<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/NCT02979704</url>
  </required_header>
  <id_info>
    <org_study_id>No.BSMMU/2016/8307</org_study_id>
    <nct_id>NCT02979704</nct_id>
  </id_info>
  <brief_title>A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia</brief_title>
  <official_title>Randomized. Open Label Trial of Comparison Between Rosuvastatin and Atorvastatin on Oxidative Stress, Inflammatory and Thrombogenic Biomarkers in Patients With Hyperlipidemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to assess the status of oxidative stress inflammation and&#xD;
      thrombogenesis in patients with hyperlipidemia and to compare the antioxidative,&#xD;
      anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hyperlipidemia is the major risk factor for development of atherosclerosis which ultimately&#xD;
      leads to cardiovascular disease (CVD), an important cause of mortality and morbidity&#xD;
      worldwide. Atherosclerosis was previously considered as a lipid storage disease but now&#xD;
      growing evidence indicates that increased oxidative stress, vascular inflammation and&#xD;
      platelet activation play an important role in the initiation and progression of&#xD;
      atherosclerosis. Among the hypolipidemic drugs, statins, 3-hydroxyl-3-methylglutaryl coenzyme&#xD;
      A (HMG-CoA) reductase inhibitors, have proved to be very much effective. Therefore, statins&#xD;
      are the most widely used hypolipidemic agents. Evidence shows that besides hypolipidemic&#xD;
      action statins possess antioxidative, anti-inflammatory and antithrombogenic effects known as&#xD;
      pleiotropic action which might play an important role in attenuating the atherosclerotic&#xD;
      process. However, pleiotropic effect varies with different members of statins.&#xD;
&#xD;
      The present prospective interventional study would be conducted in the Department of&#xD;
      Pharmacology, Department of Cardiology and Internal Medicine, BSMMU from March 2016 to August&#xD;
      2017. Total 90 cases will be selected according to inclusion and exclusion criteria. The&#xD;
      cases will be subdivided into 2 groups: group A and B. Group A consisting of 45 patients who&#xD;
      will receive rosuvastatin (5-10) mg orally once daily and Group B consisting of 45 patients&#xD;
      who will receive atorvastatin (10-20) mg orally once daily for 08 weeks. Patient's blood&#xD;
      sample will be collected to measure baseline lipid profile, malondialdehyde (MDA),&#xD;
      erythrocytic glutathione (GSH), high sensitive C-reactive protein (hs-CRP), prothrombin time&#xD;
      (PT), platelet count. After obtaining baseline data patients will be assigned to the&#xD;
      respective group. Parameters of baseline will again be evaluated after 08 weeks of&#xD;
      therapeutic intervention. Regularity of drug intake will be ensured over telephone, pill&#xD;
      count, and from the patient's compliance sheet. Patient's data will be recorded in a&#xD;
      predetermined data sheet. Patients will be informed about study, its merits and demerits in&#xD;
      easy language and then informed consent will be taken.Therefore, the present study has been&#xD;
      designed to compare the antioxidative, anti-inflammatory and antithrombogenic effects of&#xD;
      rosuvastatin and atorvastatin in hyperlipidemic patients to establish the superiority of a&#xD;
      particular statin, so that it will provide a better therapeutic option in order to prevent&#xD;
      CVD related mortality and morbidity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Phase 2/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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Establishment of superiority between rosuvastatin and atorvastatin on reduction of MDA in patients with hyperlipidemia</measure>
    <time_frame>[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]</time_frame>
    <description>Reduction of oxidative stress will be measured by changes in level of MDA in µmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment of superiority between rosuvastatin and atorvastatin on reduction of inflammation in patients with hyperlipidemia</measure>
    <time_frame>[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]</time_frame>
    <description>Reduction of inflammation will be measured by change in level of hs-CRP in mg/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment of superiority between rosuvastatin and atorvastatin on reduction platelet count in patients with hyperlipidemia</measure>
    <time_frame>[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]</time_frame>
    <description>Reduction of thrombogenesis will be measured by changes in level of platelet count in per L of blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment of superiority between rosuvastatin and atorvastatin on increase prothrombin time in patients with hyperlipidemia</measure>
    <time_frame>[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]</time_frame>
    <description>Reduction of thrombogenesis will be measured by changes in level of prothrombin time in per sec</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment of superiority between rosuvastatin and atorvastatin on increase level of erythrocytic GSH in patients with hyperlipidemia</measure>
    <time_frame>[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]</time_frame>
    <description>Reduction of oxidative stress will be measured by changes in level of erythrocytic GSH in mg/gm of Hb</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Tablet Rosuvastatin (5-10) mg orally once daily dose for 08 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Tablet Atorvastatin (10-20) mg orally once daily dose for 08 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>45 patients will be treated with rosuvastatin at a dose of (5-10) mg orally once daily dose for 08 weeks</description>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <other_name>Rocovas</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>45 patients will be treated with atorvastatin at a dose of (10-20) mg orally once daily dose for 08 weeks</description>
    <arm_group_label>Atorvastatin</arm_group_label>
    <other_name>Tiginor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age from (20-75) yrs, both male and female having LDL cholesterol: 160-190 mg/dl,&#xD;
             triglyceride (TG): 200-499 mg/dl will be recruited in the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients age &lt;25 years or &gt;75 years&#xD;
&#xD;
          -  Patients are on lipid lowering medications&#xD;
&#xD;
          -  Patients taking omega-3 fatty acid or garlic&#xD;
&#xD;
          -  Patients with history of hypersensitivity on any member of statin&#xD;
&#xD;
          -  Patients taking anti-inflammatory medications (steroid or NSAIDS)&#xD;
&#xD;
          -  Patients taking antioxidant vitamins (vitamin A, C, E)&#xD;
&#xD;
          -  Patients with impaired renal function&#xD;
&#xD;
          -  Patients with impaired liver function&#xD;
&#xD;
          -  Pregnant women and nursing mother&#xD;
&#xD;
          -  Patients having serious infections or terminal illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samia Tonu, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samia Tonu, MBBS</last_name>
    <phone>+8801769350011</phone>
    <email>tonusamia@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nargis Akhter, Mphill, Msc</last_name>
    <phone>+8801552391036</phone>
    <email>nargisakhter@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BSMMU</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samia Tonu, MBBS</last_name>
      <phone>+8801769350011</phone>
      <email>tonusamia@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Nargis Akhter, Mphill, MSc</last_name>
      <phone>+880152391036</phone>
      <email>nargisakhter@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 31, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
    <investigator_full_name>Samia Haque Tonu</investigator_full_name>
    <investigator_title>Dr. and MD resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02979704
org study id: No.BSMMU/2016/8307
nct id: NCT02979704
lead sponsor: 
has dmc: Yes
This study will be conducted to assess the status of oxidative stress inflammation and
      thrombogenesis in patients with hyperlipidemia and to compare the antioxidative,
      anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin.
Hyperlipidemia is the major risk factor for development of atherosclerosis which ultimately
      leads to cardiovascular disease (CVD), an important cause of mortality and morbidity
      worldwide. Atherosclerosis was previously considered as a lipid storage disease but now
      growing evidence indicates that increased oxidative stress, vascular inflammation and
      platelet activation play an important role in the initiation and progression of
      atherosclerosis. Among the hypolipidemic drugs, statins, 3-hydroxyl-3-methylglutaryl coenzyme
      A (HMG-CoA) reductase inhibitors, have proved to be very much effective. Therefore, statins
      are the most widely used hypolipidemic agents. Evidence shows that besides hypolipidemic
      action statins possess antioxidative, anti-inflammatory and antithrombogenic effects known as
      pleiotropic action which might play an important role in attenuating the atherosclerotic
      process. However, pleiotropic effect varies with different members of statins.

      The present prospective interventional study would be conducted in the Department of
      Pharmacology, Department of Cardiology and Internal Medicine, BSMMU from March 2016 to August
      2017. Total 90 cases will be selected according to inclusion and exclusion criteria. The
      cases will be subdivided into 2 groups: group A and B. Group A consisting of 45 patients who
      will receive rosuvastatin (5-10) mg orally once daily and Group B consisting of 45 patients
      who will receive atorvastatin (10-20) mg orally once daily for 08 weeks. Patient's blood
      sample will be collected to measure baseline lipid profile, malondialdehyde (MDA),
      erythrocytic glutathione (GSH), high sensitive C-reactive protein (hs-CRP), prothrombin time
      (PT), platelet count. After obtaining baseline data patients will be assigned to the
      respective group. Parameters of baseline will again be evaluated after 08 weeks of
      therapeutic intervention. Regularity of drug intake will be ensured over telephone, pill
      count, and from the patient's compliance sheet. Patient's data will be recorded in a
      predetermined data sheet. Patients will be informed about study, its merits and demerits in
      easy language and then informed consent will be taken.Therefore, the present study has been
      designed to compare the antioxidative, anti-inflammatory and antithrombogenic effects of
      rosuvastatin and atorvastatin in hyperlipidemic patients to establish the superiority of a
      particular statin, so that it will provide a better therapeutic option in order to prevent
      CVD related mortality and morbidity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Establishment of superiority between rosuvastatin and atorvastatin on reduction of MDA in patients with hyperlipidemia
time frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
description: Reduction of oxidative stress will be measured by changes in level of MDA in µmol/L
measure: Establishment of superiority between rosuvastatin and atorvastatin on reduction of inflammation in patients with hyperlipidemia
time frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
description: Reduction of inflammation will be measured by change in level of hs-CRP in mg/L
measure: Establishment of superiority between rosuvastatin and atorvastatin on reduction platelet count in patients with hyperlipidemia
time frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
description: Reduction of thrombogenesis will be measured by changes in level of platelet count in per L of blood
measure: Establishment of superiority between rosuvastatin and atorvastatin on increase prothrombin time in patients with hyperlipidemia
time frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
description: Reduction of thrombogenesis will be measured by changes in level of prothrombin time in per sec
measure: Establishment of superiority between rosuvastatin and atorvastatin on increase level of erythrocytic GSH in patients with hyperlipidemia
time frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
description: Reduction of oxidative stress will be measured by changes in level of erythrocytic GSH in mg/gm of Hb
arm group label: Rosuvastatin
arm group type: Active Comparator
description: Intervention: Tablet Rosuvastatin (5-10) mg orally once daily dose for 08 weeks.
arm group label: Atorvastatin
arm group type: Active Comparator
description: Intervention: Tablet Atorvastatin (10-20) mg orally once daily dose for 08 weeks
intervention type: Drug
intervention name: Rosuvastatin
description: 45 patients will be treated with rosuvastatin at a dose of (5-10) mg orally once daily dose for 08 weeks
arm group label: Rosuvastatin
other name: Rocovas
intervention type: Drug
intervention name: Atorvastatin
description: 45 patients will be treated with atorvastatin at a dose of (10-20) mg orally once daily dose for 08 weeks
arm group label: Atorvastatin
other name: Tiginor
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Samia Tonu, MBBS
role: Principal Investigator
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
last name: Samia Tonu, MBBS
phone: +8801769350011
email: tonusamia@gmail.com
last name: Nargis Akhter, Mphill, Msc
phone: +8801552391036
email: nargisakhter@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
investigator full name: Samia Haque Tonu
investigator title: Dr. and MD resident
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium
sharing ipd: No