<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/NCT03234114</url>
  </required_header>
  <id_info>
    <org_study_id>007</org_study_id>
    <nct_id>NCT03234114</nct_id>
  </id_info>
  <brief_title>Optimal Antithrombotic Therapy for ACS Patients Concomitant With AF and Implanted With New-generation DES (OPTIMA-3, 4)</brief_title>
  <official_title>Optimal Antithrombotic Therapy for Acute Coronary Syndrome Patients Concomitant With Atrial Fibrillation and Implanted With New-generation Drug-eluting Stent: OPTImal Management of Antithrombotic Agents (OPTIMA-3, 4)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</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>
      It is a multi-center randomized clinical trial (RCT) which will enroll 3746 patients with&#xD;
      acute coronary syndrome (ACS) concomitant non-valvular atrial fibrillation (NVAF) and&#xD;
      undergoing new generation drug eluting stent (DES) implantation at 70 centers nationwide in&#xD;
      China and contains two sub-studies.&#xD;
&#xD;
      In the OPTIMA-3 sub-study, 2274 subjects who choose warfarin as anticoagulant will randomly&#xD;
      receive triple antithrombotic therapy (warfarin with targeted INR 2.0-3.0, clopidogrel 75 mg&#xD;
      od and aspirin 100 mg od) for 1 month or 6 months in a 1:1 ratio then quit aspirin till 12&#xD;
      months after percutaneous coronary intervention (PCI). The primary endpoint of the OPTIMA-3&#xD;
      is a composite of cardiovascular death, myocardial infarction, ischemic stroke, systemic&#xD;
      thromboembolism and unplanned revascularization up to 12 months; the major secondary endpoint&#xD;
      is the International Society of Thrombosis and Hemostasis (ISTH) major bleeding or clinically&#xD;
      relevant non-major bleeding (CRNMB).&#xD;
&#xD;
      In the OPTIMA-4 sub-study, 1472 subjects who prefer dabigatran will be randomly assigned in a&#xD;
      1:1 ratio to a dual antithrombotic therapy of dabigatran 110 mg twice daily with ticagrelor&#xD;
      90 mg twice daily or with clopidogrel 75 mg od for 12 months after PCI. The primary safety&#xD;
      endpoint of the OPTIMA-4 is ISTH major bleeding or CRNMB at 12 months; the primary efficacy&#xD;
      endpoint is a composite of cardiovascular death, myocardial infarction, ischemic stroke,&#xD;
      systemic thromboembolism and unplanned revascularization.&#xD;
&#xD;
      Other secondary endpoints comprise death (cardiovascular, non- cardiovascular), MI (fatal or&#xD;
      non-fatal, Q-wave or non-Q-wave), unplanned revascularization (target or non-target vessel,&#xD;
      target or non-target lesion), stent thrombosis (possible, probable, definite), stroke&#xD;
      (hemorrhage or ischemic), all bleeding (ISTH and BARC criteria) and net adverse events.&#xD;
&#xD;
      All endpoints will be collected and compared between subgroups and sub-studies during&#xD;
      hospitalization and in 1 month (± 7 days), 6 months (± 7 days) and 12 months (± 7 days) for&#xD;
      office visits and in 2 weeks (± 7 days), 2 months (± 7 days) and 3 months (± 7 days) for&#xD;
      phone call visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 3, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 4</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>Primary endpoint of OPTIMA-3</measure>
    <time_frame>Up to 12 months (± 7 days) after inclusion</time_frame>
    <description>A composite of cardiovascular death, myocardial infarction, ischemic stroke, systemic thromboembolism and unplanned revascularization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary safety endpoint of OPTIMA-4</measure>
    <time_frame>Up to 12 months (± 7 days) after inclusion</time_frame>
    <description>ISTH major bleeding or CRNMB</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary efficacy endpoint of OPTIMA-4</measure>
    <time_frame>Up to 12 months (± 7 days) after inclusion</time_frame>
    <description>A composite of cardiovascular death, myocardial infarction, ischemic stroke, systemic thromboembolism and unplanned revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major secondary endpoint of OPTIMA-3</measure>
    <time_frame>Up to 12 months (± 7 days) after inclusion</time_frame>
    <description>Major bleeding or clinically relevant non-major bleeding assessed by the ISTH definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other secondary endpoints of OPTIMA-3/4</measure>
    <time_frame>Up to 12 months (± 7 days) after inclusion</time_frame>
    <description>Death (cardiovascular, non- cardiovascular), MI (fatal or non-fatal, Q-wave or non-Q-wave), unplanned revascularization (target or non-target vessel, target or non-target lesion), stent thrombosis (possible, probable, definite), stroke (hemorrhage or ischemic), all bleeding (ISTH and BARC criteria) and net adverse events</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adenosine diphosphate (ADP, final concentration 5 μmol/L) induced platelet aggregation (PLADP)</measure>
    <time_frame>The venous blood will be collected at 7:30 a.m. on the day of discharge and tested within 2 hours.</time_frame>
    <description>The PLADP will be detected by light transmission aggregometry (LTA) to reflect platelet function under the treatment of clopidogrel or ticagrelor.</description>
  </other_outcome>
  <other_outcome>
    <measure>Arachidonic acid (AA, final concentration 1 mmol/L) induced platelet aggregation (PLAA)</measure>
    <time_frame>The venous blood will be collected at 7:30 a.m. on the day of discharge and tested within 2 hours.</time_frame>
    <description>The PLAA will be detected by light transmission aggregometry (LTA) to reflect platelet function under the treatment of aspirin.</description>
  </other_outcome>
  <other_outcome>
    <measure>Trough concentration of dabigatran (Cmin)</measure>
    <time_frame>The venous blood will be collected at 0.5 hour before dosing after the patients taking at least 3 days of dabigatran and detected after stored below -80℃ for at most 2 months.</time_frame>
    <description>The trough concentration of dabigatran (Cmin) of dabigatran is to be detected by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS) in OPTIMA-4 trial.</description>
  </other_outcome>
  <other_outcome>
    <measure>Single nucleotide polymorphisms (SNPs)</measure>
    <time_frame>The venous blood will be collected at any time during hospitalization and detected after stored below -80℃ for at most 5 years.</time_frame>
    <description>The single nucleotide polymorphisms (SNPs) related to the antithrombotic agents used in different groups will be detected as follows: (1) clopidogrel-related SNPs: CYP2C19 (rs12248560, rs28399504, rs41291556, rs4244285, rs4986893, rs5633701, rs72552267, rs72558186); (2) ticagrelor-related SNPs: SLCO1B1 (rs113681054), OATP1B1 (rs4149056), CYP3A4 (rs62471956, rs56324128), UGT2B7 (rs61361928); (3) dabigatran-related SNP: ABCB1 (rs4148738, rs1045642), CES1 (rs8192935).</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">3746</enrollment>
  <condition>Acute Coronary Syndrome (ACS)</condition>
  <condition>Non-valvular Atrial Fibrillation (NVAF)</condition>
  <arm_group>
    <arm_group_label>1-month TAT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized experimental group in the OPTIMA-3 substudy; Triple antithrombotic therapy (warfarin with targeted INR 2.0-3.0, clopidogrel 75 mg q.d. and aspirin 100 mg q.d.) for 1 month (30 days) then quit aspirin till 12 months after PCI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6-month TAT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized control group in the OPTIMA-3 substudy; Triple antithrombotic therapy (warfarin with targeted INR 2.0-3.0, clopidogrel 75 mg q.d. and aspirin 100 mg q.d.) for 6 months (180 days）then quit aspirin till 12 months after PCI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>12-month DAT-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized experimental group in the OPTIMA-4 substudy; Dual antithrombotic therapy including dabigatran 110 mg b.i.d. with clopidogrel 75 mg q.d. for 12 months after PCI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>12-month DAT-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized control group in the OPTIMA-4 substudy; Dual antithrombotic therapy including dabigatran 110 mg b.i.d. with ticagrelor 90 mg b.i.d for 12 months after PCI</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triple antithrombotic therapy</intervention_name>
    <description>Including warfarin with targeted INR 2.0-3.0 (Shanghai Xinyi pharma co., LTD, China), aspirin 100 mg q.d. (Bayer, Germany) and clopidogrel 75 mg q.d. (Sanofi, France)</description>
    <arm_group_label>1-month TAT</arm_group_label>
    <arm_group_label>6-month TAT</arm_group_label>
    <other_name>TAT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dual antithrombotc therapy-1</intervention_name>
    <description>Including dabigatran 110 mg b.i.d. (Boehringer Ingelheim, Germany) plus clopidogrel 75 mg q.d. (Sanofi, France)</description>
    <arm_group_label>12-month DAT-1</arm_group_label>
    <other_name>DAT-1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dual antithrombotc therapy-2</intervention_name>
    <description>Including dabigatran 110 mg b.i.d. (Boehringer Ingelheim, Germany) plus ticagrelor 90 mg b.i.d. (AstraZeneca, Britain)</description>
    <arm_group_label>12-month DAT-2</arm_group_label>
    <other_name>DAT-2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years;&#xD;
&#xD;
          -  ACS patients concomitant non-valvular AF (paroxysmal, persistent and permanent)&#xD;
             underwent PCI and new-generation DES implantation;&#xD;
&#xD;
          -  CHA2DS2-VASc score ≥ 2;&#xD;
&#xD;
          -  Acceptable risk of bleeding at the discretion of the researchers (e.g. HAS-BLED score&#xD;
             ≤ 2)&#xD;
&#xD;
          -  Consent to participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DES implanted in the left main coronary artery&#xD;
&#xD;
          -  Cardiogenic shock or Killip III-IV&#xD;
&#xD;
          -  STEMI patients with malignant arrhythmias or underwent electrodefibrillation or CPR or&#xD;
             with cardiac mechanical complications (heart rupture, ventricular septal perforation,&#xD;
             nipple muscle fracture, etc.)&#xD;
&#xD;
          -  History of gastrointestinal or intracranial hemorrhage; active bleeding, trauma or&#xD;
             major surgery within one month; suspected or diagnosed aortic dissection&#xD;
&#xD;
          -  Ischemic stroke with limb dysfunction or dysphasia&#xD;
&#xD;
          -  Known allergy or intolerance to the study medications: warfarin, clopidogrel, aspirin,&#xD;
             dabigatran, ticagrelor and heparin&#xD;
&#xD;
          -  Participating in other ongoing trials&#xD;
&#xD;
          -  Planned surgery in 12 months requiring to withdraw the antiplatelet agents&#xD;
&#xD;
          -  Planned RFCA or left atrial appendage occlusion in the next 12m&#xD;
&#xD;
          -  Abnormal liver or kidney function (ALT ≥ 3 ULN; estimated CrCl &lt; 30 ml/min calculated&#xD;
             by Cockcroft-Gault equation); diagnosed liver cirrhosis&#xD;
&#xD;
          -  Hematological disease with bleeding tendency; hemoglobin &lt; 100 g/L, platelet count &lt;&#xD;
             100 × 10^9 /L&#xD;
&#xD;
          -  Malignancies or life expectancy less than 1 year&#xD;
&#xD;
          -  Pregnant (present, suspected, or planned) or lactating woman&#xD;
&#xD;
          -  Patients who are taking drugs which may interact with study agents, such as&#xD;
             miconazole, ketoconazole, fluconazole, voriconazole, itraconazole, posaconazole,&#xD;
             efinaconazole, and rifampicin, etc.&#xD;
&#xD;
          -  Patients with any other conditions that may not be suitable to participate in the&#xD;
             trial at the discretion of the researchers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chunjian Li, Dr, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chunjian Li, Dr, PhD</last_name>
    <phone>+86-13701465229</phone>
    <email>drcjli@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaoxuan Gong, MD</last_name>
    <phone>+86-18851727059</phone>
    <email>xiaoxuangong@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fuming Zhang, M.D.</last_name>
      <phone>+86-25-83718836</phone>
      <phone_ext>6360</phone_ext>
      <email>jsphkj@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yi Chai, M.D.</last_name>
      <phone>+86-25-83718836</phone>
      <phone_ext>6360</phone_ext>
      <email>jsphkj@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Chunjian Li, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiaoxuan Gong, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Chunjian Li</investigator_full_name>
    <investigator_title>Dr., MD, Ph.D, Director of CCU Ward</investigator_title>
  </responsible_party>
  <keyword>new generation drug eluting stent (DES)</keyword>
  <keyword>antithrombotic therapy</keyword>
  <keyword>randomized clinical trial (RCT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_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/NCT03234114
org study id: 007
nct id: NCT03234114
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is a multi-center randomized clinical trial (RCT) which will enroll 3746 patients with
      acute coronary syndrome (ACS) concomitant non-valvular atrial fibrillation (NVAF) and
      undergoing new generation drug eluting stent (DES) implantation at 70 centers nationwide in
      China and contains two sub-studies.

      In the OPTIMA-3 sub-study, 2274 subjects who choose warfarin as anticoagulant will randomly
      receive triple antithrombotic therapy (warfarin with targeted INR 2.0-3.0, clopidogrel 75 mg
      od and aspirin 100 mg od) for 1 month or 6 months in a 1:1 ratio then quit aspirin till 12
      months after percutaneous coronary intervention (PCI). The primary endpoint of the OPTIMA-3
      is a composite of cardiovascular death, myocardial infarction, ischemic stroke, systemic
      thromboembolism and unplanned revascularization up to 12 months; the major secondary endpoint
      is the International Society of Thrombosis and Hemostasis (ISTH) major bleeding or clinically
      relevant non-major bleeding (CRNMB).

      In the OPTIMA-4 sub-study, 1472 subjects who prefer dabigatran will be randomly assigned in a
      1:1 ratio to a dual antithrombotic therapy of dabigatran 110 mg twice daily with ticagrelor
      90 mg twice daily or with clopidogrel 75 mg od for 12 months after PCI. The primary safety
      endpoint of the OPTIMA-4 is ISTH major bleeding or CRNMB at 12 months; the primary efficacy
      endpoint is a composite of cardiovascular death, myocardial infarction, ischemic stroke,
      systemic thromboembolism and unplanned revascularization.

      Other secondary endpoints comprise death (cardiovascular, non- cardiovascular), MI (fatal or
      non-fatal, Q-wave or non-Q-wave), unplanned revascularization (target or non-target vessel,
      target or non-target lesion), stent thrombosis (possible, probable, definite), stroke
      (hemorrhage or ischemic), all bleeding (ISTH and BARC criteria) and net adverse events.

      All endpoints will be collected and compared between subgroups and sub-studies during
      hospitalization and in 1 month (± 7 days), 6 months (± 7 days) and 12 months (± 7 days) for
      office visits and in 2 weeks (± 7 days), 2 months (± 7 days) and 3 months (± 7 days) for
      phone call visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary endpoint of OPTIMA-3
time frame: Up to 12 months (± 7 days) after inclusion
description: A composite of cardiovascular death, myocardial infarction, ischemic stroke, systemic thromboembolism and unplanned revascularization
measure: Primary safety endpoint of OPTIMA-4
time frame: Up to 12 months (± 7 days) after inclusion
description: ISTH major bleeding or CRNMB
measure: Primary efficacy endpoint of OPTIMA-4
time frame: Up to 12 months (± 7 days) after inclusion
description: A composite of cardiovascular death, myocardial infarction, ischemic stroke, systemic thromboembolism and unplanned revascularization
measure: Major secondary endpoint of OPTIMA-3
time frame: Up to 12 months (± 7 days) after inclusion
description: Major bleeding or clinically relevant non-major bleeding assessed by the ISTH definition
measure: Other secondary endpoints of OPTIMA-3/4
time frame: Up to 12 months (± 7 days) after inclusion
description: Death (cardiovascular, non- cardiovascular), MI (fatal or non-fatal, Q-wave or non-Q-wave), unplanned revascularization (target or non-target vessel, target or non-target lesion), stent thrombosis (possible, probable, definite), stroke (hemorrhage or ischemic), all bleeding (ISTH and BARC criteria) and net adverse events
measure: Adenosine diphosphate (ADP, final concentration 5 μmol/L) induced platelet aggregation (PLADP)
time frame: The venous blood will be collected at 7:30 a.m. on the day of discharge and tested within 2 hours.
description: The PLADP will be detected by light transmission aggregometry (LTA) to reflect platelet function under the treatment of clopidogrel or ticagrelor.
measure: Arachidonic acid (AA, final concentration 1 mmol/L) induced platelet aggregation (PLAA)
time frame: The venous blood will be collected at 7:30 a.m. on the day of discharge and tested within 2 hours.
description: The PLAA will be detected by light transmission aggregometry (LTA) to reflect platelet function under the treatment of aspirin.
measure: Trough concentration of dabigatran (Cmin)
time frame: The venous blood will be collected at 0.5 hour before dosing after the patients taking at least 3 days of dabigatran and detected after stored below -80℃ for at most 2 months.
description: The trough concentration of dabigatran (Cmin) of dabigatran is to be detected by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS) in OPTIMA-4 trial.
measure: Single nucleotide polymorphisms (SNPs)
time frame: The venous blood will be collected at any time during hospitalization and detected after stored below -80℃ for at most 5 years.
description: The single nucleotide polymorphisms (SNPs) related to the antithrombotic agents used in different groups will be detected as follows: (1) clopidogrel-related SNPs: CYP2C19 (rs12248560, rs28399504, rs41291556, rs4244285, rs4986893, rs5633701, rs72552267, rs72558186); (2) ticagrelor-related SNPs: SLCO1B1 (rs113681054), OATP1B1 (rs4149056), CYP3A4 (rs62471956, rs56324128), UGT2B7 (rs61361928); (3) dabigatran-related SNP: ABCB1 (rs4148738, rs1045642), CES1 (rs8192935).
arm group label: 1-month TAT
arm group type: Experimental
description: Randomized experimental group in the OPTIMA-3 substudy; Triple antithrombotic therapy (warfarin with targeted INR 2.0-3.0, clopidogrel 75 mg q.d. and aspirin 100 mg q.d.) for 1 month (30 days) then quit aspirin till 12 months after PCI
arm group label: 6-month TAT
arm group type: Experimental
description: Randomized control group in the OPTIMA-3 substudy; Triple antithrombotic therapy (warfarin with targeted INR 2.0-3.0, clopidogrel 75 mg q.d. and aspirin 100 mg q.d.) for 6 months (180 days）then quit aspirin till 12 months after PCI
arm group label: 12-month DAT-1
arm group type: Experimental
description: Randomized experimental group in the OPTIMA-4 substudy; Dual antithrombotic therapy including dabigatran 110 mg b.i.d. with clopidogrel 75 mg q.d. for 12 months after PCI
arm group label: 12-month DAT-2
arm group type: Experimental
description: Randomized control group in the OPTIMA-4 substudy; Dual antithrombotic therapy including dabigatran 110 mg b.i.d. with ticagrelor 90 mg b.i.d for 12 months after PCI
intervention type: Drug
intervention name: Triple antithrombotic therapy
description: Including warfarin with targeted INR 2.0-3.0 (Shanghai Xinyi pharma co., LTD, China), aspirin 100 mg q.d. (Bayer, Germany) and clopidogrel 75 mg q.d. (Sanofi, France)
arm group label: 1-month TAT
arm group label: 6-month TAT
other name: TAT
intervention type: Drug
intervention name: Dual antithrombotc therapy-1
description: Including dabigatran 110 mg b.i.d. (Boehringer Ingelheim, Germany) plus clopidogrel 75 mg q.d. (Sanofi, France)
arm group label: 12-month DAT-1
other name: DAT-1
intervention type: Drug
intervention name: Dual antithrombotc therapy-2
description: Including dabigatran 110 mg b.i.d. (Boehringer Ingelheim, Germany) plus ticagrelor 90 mg b.i.d. (AstraZeneca, Britain)
arm group label: 12-month DAT-2
other name: DAT-2
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chunjian Li, Dr, PhD
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Chunjian Li, Dr, PhD
phone: +86-13701465229
email: drcjli@hotmail.com
last name: Xiaoxuan Gong, MD
phone: +86-18851727059
email: xiaoxuangong@sina.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: Chunjian Li
investigator title: Dr., MD, Ph.D, Director of CCU Ward
mesh term: Atrial Fibrillation
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No