xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998525</url>
    </required_header>
    <id_info>
      <org_study_id>2</org_study_id>
      <nct_id>NCT05998525</nct_id>
    </id_info>
    <brief_title>Dapagliflozin Effects on Coronary Calcium and Epicardial Fat Assessed by Cardiotomography</brief_title>
    <official_title>Dapagliflozin Effects on Coronary Calcium and Epicardial Fat Assessed by Cardiotomography</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hilda Elizabeth Macías Cervantes</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto Mexicano del Seguro Social</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Calcification of the coronary arteries is a direct sign of atherosclerotic disease of the&#xD;
        coronary arteries and has been shown to be a strong predictor of the risk of cardiovascular&#xD;
        diseases, including myocardial infarction and/or cardiac death, especially in patients with&#xD;
        Diabetes Mellitus type 2. Therefore, there is great interest in pharmacotherapies that&#xD;
        improve the rates of cardiovascular complications, and modify the outcomes of this group of&#xD;
        patients.&#xD;
  &#xD;
        Large randomized controlled trials with SGLT2 inhibitors in patients with DM2 have shown a&#xD;
        clear reduction in cardiovascular events among individuals with atherosclerotic disease.&#xD;
        Atherosclerosis imaging allows measurable assessments of disease progression and activity,&#xD;
        revealing early signs of potential drug effects. Noninvasive methods are preferred for serial&#xD;
        imaging in drug trials due to the potential risks associated with invasive procedures. The&#xD;
        coronary artery calcium quantification using the Agatston score is the most widely used&#xD;
        method&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is now well recognized that Coronary Artery Disease (CAD) is part of the spectrum of&#xD;
        cardiovascular diseases (CVDs) that have common underlying risk factors and may manifest as&#xD;
        myocardial infarction, stroke or death.&#xD;
  &#xD;
        CAD is a pathological process characterized by the accumulation of atherosclerotic plaque in&#xD;
        the epicardial arteries, whether obstructive or non-obstructive; it can have long and stable&#xD;
        periods, but it can also become unstable at any time.&#xD;
  &#xD;
        It is unknown whether the high risk provided by the presence of obstructive coronary artery&#xD;
        atherosclerotic disease is due to stenosis per se, or due to its correlation with the total&#xD;
        burden of atherosclerotic plaque. Studies suggest that calcified atherosclerotic burden, not&#xD;
        stenosis, is the main predictor of future events of cardiovascular disease (myocardial&#xD;
        infarction and cerebrovascular disease) and death in patients with coronary artery disease.&#xD;
  &#xD;
        Atherosclerosis imaging allows measurable assessments of disease progression and activity,&#xD;
        revealing early signs of potential drug effects. Non-invasive methods are preferable for&#xD;
        serial imaging in drug trials because of the potential risks associated with invasive&#xD;
        procedures. High participant dropout rates are also observed when invasive methods are used.&#xD;
  &#xD;
        Therefore, coronary artery calcium scanning offers a simple, non-invasive, rapid, and&#xD;
        reliable method to quantify coronary calcium, which is pathognomonic for established&#xD;
        atherosclerosis. It is a powerful screening tool for asymptomatic patients at low or&#xD;
        intermediate risk of CVD, including those with diabetes mellitus, and can potentially improve&#xD;
        adherence to lifestyle advice and medication.&#xD;
  &#xD;
        Coronary artery calcium can be quantified by non-contrast-enhanced CT using the Agatston&#xD;
        score, which is currently the most widely used method. Conceptually, the Agatston score is&#xD;
        the sum of the scores for all calcified coronary lesions, representing both the total area&#xD;
        and the maximum density of coronary calcification. The area of the lesion is multiplied by&#xD;
        the density factor that is determined by pre-defined cut points. The density factor is used&#xD;
        so that the regions with higher attenuation contribute more strongly to the final calcium&#xD;
        score. A CT attenuation threshold of 130 Hounsfield units (HU) is used for calcium detection,&#xD;
        and only contiguous voxels totaling an area greater than 1 mm2 are counted as &quot;lesions&quot; to&#xD;
        reduce the influence of image noise. Standardized categories have been developed for the&#xD;
        calcium score with scores of 0 indicating the absence of calcified plaque, 1 to 10 minimal&#xD;
        plaque, 11 to 100 mild plaque, 101 to 400 moderate plaque, and &gt; 400 severe plaque.&#xD;
  &#xD;
        In 2017, the Society of Cardiovascular Computed Tomography (SCCT) and the Society of Thoracic&#xD;
        Radiology (STR) proposed the CAC-DRS as a way to standardize communication regarding CAC&#xD;
        findings on non-contrast-enhanced CT scans. CAC-DRS categories are defined as Ax/Ny, where A&#xD;
        represents the Agatston score group (where A0, A1, A2, and A3 represent CAC of 0, CAC of&#xD;
        1-99, CAC of 100-299, and CAC ≥ 300, respectively), and N represents the number of vessels&#xD;
        affected by CAC, ranging from 0 to 4 for the major epicardial coronary arteries.,&#xD;
        respectively), and N represents the number of vessels affected by CAC, which varies from 0 to&#xD;
        4 for the main epicardial coronary arteries.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 21, 2021</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Any patient presenting with a diagnosis of acute myocardial infarction with and without ST segment elevation will be explained the objective of the study and after performing percutaneous coronary intervention they will be randomized using an excel sheet to one of two groups, the intervention group will receive Dapagliflozin 10 mg every 24 hours and the control group will receive placebo. In both groups, a simple cardiotomography was performed to evaluate the calcium score and epicardial fat at baseline and after 12 months of intervention.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The blinding will be double blind, since neither the patient, the responsible investigator, the radiologists and the one who will perform the statistical analysis will know to which group each patient was assigned.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in the coronary calcium score quantified by Agatston's score using simple coronary tomography. Quantified in agatston units (AU)</measure>
      <time_frame>A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.</time_frame>
      <description>Standardized categories have been developed for the calcium score with scores of 0 indicating the absence of calcified plaque, 1 to 10 minimal plaque, 11 to 100 mild plaque, 101 to 400 moderate plaque, and &gt; 400 severe plaque. This is evaluated by the Agatston score. cardiac tomography will be performed on admission prior to hospital discharge and after 12 months of treatment in both groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>changes in cardiac epicardial fat volume quantified in cm3 and evaluated by simple cardiac tomography.</measure>
      <time_frame>A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.</time_frame>
      <description>Visceral fat depot of the heart and can secrete bioactive molecules that have modulatory effects on the myocardium. Cardiac tomography will be performed on admission prior to hospital discharge and after 12 months of treatment in both groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients with progression of atherosclerotic disease. The increase in coronary calcium and the increase in epicardial fat after 12 months of treatment will be considered as progression.</measure>
      <time_frame>A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.</time_frame>
      <description>Determine changes in the total burden of atherosclerotic disease with the use of Dapagliflozin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with new event of acute myocardial infarction</measure>
      <time_frame>12 months</time_frame>
      <description>Determine the association of the coronary calcium score on the development of acute myocardial infarction in both study groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with new event of unstable angina</measure>
      <time_frame>12 months</time_frame>
      <description>Determine the association of the coronary calcium score on the development of unstable angina in both study groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality due to cardiovascular causes</measure>
      <time_frame>12 months</time_frame>
      <description>During the follow-up of the study, the cause of cardiovascular origin will be taken as that related to acute myocardial infarction or worsening of heart failure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">54</enrollment>
    <condition>Diabete Type 2</condition>
    <condition>Unstable Angina</condition>
    <condition>Myocardial Infarction</condition>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Dapagliflozin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dapagliflozin 10 mg orally every 24 hours for 12 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo orally every 24 hours for 12 months</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dapagliflozin 10Mg Tab</intervention_name>
      <description>patients who meet the inclusion criteria and after catheterization will be randomized to receive Dapagliflozin 10 mg every 24 hours and upon dischargetreatment will continue for 12 months</description>
      <arm_group_label>Dapagliflozin</arm_group_label>
      <other_name>Forxiga</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>patients who meet the inclusion criteria and after catheterization will be randomized to receive a placebo pill 24 hours and upon discharge treatment will continue for 12 months</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>Placebo pill</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female patients over 18 years of age&#xD;
  &#xD;
            -  Who meet the criteria of the fourth definition of infarction with and without ST&#xD;
               segment elevation&#xD;
  &#xD;
            -  Known with diabetes mellitus 2 or newly diagnosed diabetes according to ADA criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with Type 1 Diabetes Mellitus&#xD;
  &#xD;
            -  Patients on chronic replacement therapy for renal function using peritoneal dialysis&#xD;
               or hemodialysis or with GFR less than 30 ml / min / 1.73m2&#xD;
  &#xD;
            -  Patients who have recently undergone immunosuppressive therapy&#xD;
  &#xD;
            -  Patients with a history of recurrent urinary tract infection&#xD;
  &#xD;
            -  Patients known to be allergic to SGLT-2 inhibitors&#xD;
  &#xD;
            -  Patients presenting as sudden aborted death.&#xD;
  &#xD;
            -  Patients who after percutaneous coronary intervention require orotracheal intubation&#xD;
               or present a state of shock&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Unidad Medica de Alta Especialidad No. 1, Bajío</name>
        <address>
          <city>Leon</city>
          <state>Guanajuato</state>
          <zip>37260,</zip>
          <country>Mexico</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <results_reference>
      <citation>Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4242.</citation>
      <PMID>31504439</PMID>
    </results_reference>
    <results_reference>
      <citation>Glass CK, Witztum JL. Atherosclerosis. the road ahead. Cell. 2001 Feb 23;104(4):503-16. doi: 10.1016/s0092-8674(01)00238-0. No abstract available.</citation>
      <PMID>11239408</PMID>
    </results_reference>
    <results_reference>
      <citation>Mortensen MB, Dzaye O, Steffensen FH, Botker HE, Jensen JM, Ronnow Sand NP, Kragholm KH, Sorensen HT, Leipsic J, Maeng M, Blaha MJ, Norgaard BL. Impact of Plaque Burden Versus Stenosis on Ischemic Events in Patients With Coronary Atherosclerosis. J Am Coll Cardiol. 2020 Dec 15;76(24):2803-2813. doi: 10.1016/j.jacc.2020.10.021.</citation>
      <PMID>33303068</PMID>
    </results_reference>
    <results_reference>
      <citation>Terasaki M, Hiromura M, Mori Y, Kohashi K, Nagashima M, Kushima H, Watanabe T, Hirano T. Amelioration of Hyperglycemia with a Sodium-Glucose Cotransporter 2 Inhibitor Prevents Macrophage-Driven Atherosclerosis through Macrophage Foam Cell Formation Suppression in Type 1 and Type 2 Diabetic Mice. PLoS One. 2015 Nov 25;10(11):e0143396. doi: 10.1371/journal.pone.0143396. eCollection 2015.</citation>
      <PMID>26606676</PMID>
    </results_reference>
    <results_reference>
      <citation>Hecht HS. Coronary artery calcium scanning: past, present, and future. JACC Cardiovasc Imaging. 2015 May;8(5):579-596. doi: 10.1016/j.jcmg.2015.02.006.</citation>
      <PMID>25937196</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 27, 2021</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Instituto Mexicano del Seguro Social</investigator_affiliation>
      <investigator_full_name>Hilda Elizabeth Macías Cervantes</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <keyword>Dapagliflozin</keyword>
    <keyword>coronary calcium</keyword>
    <keyword>Atherosclerosis</keyword>
    <keyword>Myocardial Infarction</keyword>
    <keyword>Agatston score</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Angina, Unstable</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dapagliflozin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The provision of data can be by direct request to the principal investigator</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998525
  org study id: 2
  nct id: NCT05998525
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Calcification of the coronary arteries is a direct sign of atherosclerotic disease of the
        coronary arteries and has been shown to be a strong predictor of the risk of cardiovascular
        diseases, including myocardial infarction and/or cardiac death, especially in patients with
        Diabetes Mellitus type 2. Therefore, there is great interest in pharmacotherapies that
        improve the rates of cardiovascular complications, and modify the outcomes of this group of
        patients.
  
        Large randomized controlled trials with SGLT2 inhibitors in patients with DM2 have shown a
        clear reduction in cardiovascular events among individuals with atherosclerotic disease.
        Atherosclerosis imaging allows measurable assessments of disease progression and activity,
        revealing early signs of potential drug effects. Noninvasive methods are preferred for serial
        imaging in drug trials due to the potential risks associated with invasive procedures. The
        coronary artery calcium quantification using the Agatston score is the most widely used
        method
  It is now well recognized that Coronary Artery Disease (CAD) is part of the spectrum of
        cardiovascular diseases (CVDs) that have common underlying risk factors and may manifest as
        myocardial infarction, stroke or death.
  
        CAD is a pathological process characterized by the accumulation of atherosclerotic plaque in
        the epicardial arteries, whether obstructive or non-obstructive; it can have long and stable
        periods, but it can also become unstable at any time.
  
        It is unknown whether the high risk provided by the presence of obstructive coronary artery
        atherosclerotic disease is due to stenosis per se, or due to its correlation with the total
        burden of atherosclerotic plaque. Studies suggest that calcified atherosclerotic burden, not
        stenosis, is the main predictor of future events of cardiovascular disease (myocardial
        infarction and cerebrovascular disease) and death in patients with coronary artery disease.
  
        Atherosclerosis imaging allows measurable assessments of disease progression and activity,
        revealing early signs of potential drug effects. Non-invasive methods are preferable for
        serial imaging in drug trials because of the potential risks associated with invasive
        procedures. High participant dropout rates are also observed when invasive methods are used.
  
        Therefore, coronary artery calcium scanning offers a simple, non-invasive, rapid, and
        reliable method to quantify coronary calcium, which is pathognomonic for established
        atherosclerosis. It is a powerful screening tool for asymptomatic patients at low or
        intermediate risk of CVD, including those with diabetes mellitus, and can potentially improve
        adherence to lifestyle advice and medication.
  
        Coronary artery calcium can be quantified by non-contrast-enhanced CT using the Agatston
        score, which is currently the most widely used method. Conceptually, the Agatston score is
        the sum of the scores for all calcified coronary lesions, representing both the total area
        and the maximum density of coronary calcification. The area of the lesion is multiplied by
        the density factor that is determined by pre-defined cut points. The density factor is used
        so that the regions with higher attenuation contribute more strongly to the final calcium
        score. A CT attenuation threshold of 130 Hounsfield units (HU) is used for calcium detection,
        and only contiguous voxels totaling an area greater than 1 mm2 are counted as "lesions" to
        reduce the influence of image noise. Standardized categories have been developed for the
        calcium score with scores of 0 indicating the absence of calcified plaque, 1 to 10 minimal
        plaque, 11 to 100 mild plaque, 101 to 400 moderate plaque, and > 400 severe plaque.
  
        In 2017, the Society of Cardiovascular Computed Tomography (SCCT) and the Society of Thoracic
        Radiology (STR) proposed the CAC-DRS as a way to standardize communication regarding CAC
        findings on non-contrast-enhanced CT scans. CAC-DRS categories are defined as Ax/Ny, where A
        represents the Agatston score group (where A0, A1, A2, and A3 represent CAC of 0, CAC of
        1-99, CAC of 100-299, and CAC ≥ 300, respectively), and N represents the number of vessels
        affected by CAC, ranging from 0 to 4 for the major epicardial coronary arteries.,
        respectively), and N represents the number of vessels affected by CAC, which varies from 0 to
        4 for the main epicardial coronary arteries.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Any patient presenting with a diagnosis of acute myocardial infarction with and without ST segment elevation will be explained the objective of the study and after performing percutaneous coronary intervention they will be randomized using an excel sheet to one of two groups, the intervention group will receive Dapagliflozin 10 mg every 24 hours and the control group will receive placebo. In both groups, a simple cardiotomography was performed to evaluate the calcium score and epicardial fat at baseline and after 12 months of intervention.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The blinding will be double blind, since neither the patient, the responsible investigator, the radiologists and the one who will perform the statistical analysis will know to which group each patient was assigned.
  measure: Changes in the coronary calcium score quantified by Agatston's score using simple coronary tomography. Quantified in agatston units (AU)
  time frame: A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.
  description: Standardized categories have been developed for the calcium score with scores of 0 indicating the absence of calcified plaque, 1 to 10 minimal plaque, 11 to 100 mild plaque, 101 to 400 moderate plaque, and > 400 severe plaque. This is evaluated by the Agatston score. cardiac tomography will be performed on admission prior to hospital discharge and after 12 months of treatment in both groups.
  measure: changes in cardiac epicardial fat volume quantified in cm3 and evaluated by simple cardiac tomography.
  time frame: A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.
  description: Visceral fat depot of the heart and can secrete bioactive molecules that have modulatory effects on the myocardium. Cardiac tomography will be performed on admission prior to hospital discharge and after 12 months of treatment in both groups.
  measure: Number of patients with progression of atherosclerotic disease. The increase in coronary calcium and the increase in epicardial fat after 12 months of treatment will be considered as progression.
  time frame: A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.
  description: Determine changes in the total burden of atherosclerotic disease with the use of Dapagliflozin
  measure: Number of patients with new event of acute myocardial infarction
  time frame: 12 months
  description: Determine the association of the coronary calcium score on the development of acute myocardial infarction in both study groups
  measure: Number of patients with new event of unstable angina
  time frame: 12 months
  description: Determine the association of the coronary calcium score on the development of unstable angina in both study groups
  measure: Mortality due to cardiovascular causes
  time frame: 12 months
  description: During the follow-up of the study, the cause of cardiovascular origin will be taken as that related to acute myocardial infarction or worsening of heart failure
  arm group label: Dapagliflozin
  arm group type: Experimental
  description: Dapagliflozin 10 mg orally every 24 hours for 12 months
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo orally every 24 hours for 12 months
  intervention type: Drug
  intervention name: Dapagliflozin 10Mg Tab
  description: patients who meet the inclusion criteria and after catheterization will be randomized to receive Dapagliflozin 10 mg every 24 hours and upon dischargetreatment will continue for 12 months
  arm group label: Dapagliflozin
  other name: Forxiga
  intervention type: Drug
  intervention name: Placebo
  description: patients who meet the inclusion criteria and after catheterization will be randomized to receive a placebo pill 24 hours and upon discharge treatment will continue for 12 months
  arm group label: Placebo
  other name: Placebo pill
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: Mexico
  citation: Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4242.
  PMID: 31504439
  citation: Glass CK, Witztum JL. Atherosclerosis. the road ahead. Cell. 2001 Feb 23;104(4):503-16. doi: 10.1016/s0092-8674(01)00238-0. No abstract available.
  PMID: 11239408
  citation: Mortensen MB, Dzaye O, Steffensen FH, Botker HE, Jensen JM, Ronnow Sand NP, Kragholm KH, Sorensen HT, Leipsic J, Maeng M, Blaha MJ, Norgaard BL. Impact of Plaque Burden Versus Stenosis on Ischemic Events in Patients With Coronary Atherosclerosis. J Am Coll Cardiol. 2020 Dec 15;76(24):2803-2813. doi: 10.1016/j.jacc.2020.10.021.
  PMID: 33303068
  citation: Terasaki M, Hiromura M, Mori Y, Kohashi K, Nagashima M, Kushima H, Watanabe T, Hirano T. Amelioration of Hyperglycemia with a Sodium-Glucose Cotransporter 2 Inhibitor Prevents Macrophage-Driven Atherosclerosis through Macrophage Foam Cell Formation Suppression in Type 1 and Type 2 Diabetic Mice. PLoS One. 2015 Nov 25;10(11):e0143396. doi: 10.1371/journal.pone.0143396. eCollection 2015.
  PMID: 26606676
  citation: Hecht HS. Coronary artery calcium scanning: past, present, and future. JACC Cardiovasc Imaging. 2015 May;8(5):579-596. doi: 10.1016/j.jcmg.2015.02.006.
  PMID: 25937196
  responsible party type: Sponsor-Investigator
  investigator affiliation: Instituto Mexicano del Seguro Social
  investigator full name: Hilda Elizabeth Macías Cervantes
  investigator title: principal investigator
  mesh term: Myocardial Infarction
  mesh term: Angina, Unstable
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Infarction
  mesh term: Dapagliflozin
  sharing ipd: Yes
  ipd description: The provision of data can be by direct request to the principal investigator
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)