<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/NCT03273322</url>
  </required_header>
  <id_info>
    <org_study_id>P161102J</org_study_id>
    <nct_id>NCT03273322</nct_id>
  </id_info>
  <brief_title>Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure</brief_title>
  <acronym>ADRIFT</acronym>
  <official_title>Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure: The Randomized ADRIFT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Action Research Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy&#xD;
      (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at&#xD;
      10 and 90 days: central laboratory hemostasis analysis and clinical events assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data on antithrombotic therapy after Left Atrial Appendage Closure (LAAC) are scarce and no&#xD;
      randomized evaluation has been performed to demonstrate what is the best antithrombotic&#xD;
      strategy following LAAC. LAAC is classically associated with a 6-week period of&#xD;
      anticoagulation with warfarin + aspirin followed by once daily clopidogrel (75 mg) + aspirin&#xD;
      (81-325 mg) until the 6 months visit, then aspirin alone is continued indefinitely, as tested&#xD;
      in patients without contraindication for anticoagulation in the pivotal Watchman trials. LAAC&#xD;
      is mostly used in Europe as an alternative to warfarin anticoagulation when patients have a&#xD;
      contraindication to or are unsuitable for warfarin anticoagulation. The classic regimen is&#xD;
      not applicable and believed to be too risky in such frail patients. These patients usually&#xD;
      receive a regimen of daily clopidogrel + aspirin followed by single antiplatelet therapy&#xD;
      (most frequently used treatment). Some patients receive oral anticoagulation without aspirin,&#xD;
      including NOAC anticoagulation. Rivaroxaban is a tempting strategy for anticoagulation&#xD;
      following LAAC in atrial fibrillation (AF) patients. The dose needs first to be carefully&#xD;
      evaluated the trial propose a dose ranging study in patients who have undergone successful&#xD;
      LAAC.&#xD;
&#xD;
      The study will evaluate two different Rivaroxaban regimen (10 or 15 mg a day) in comparison&#xD;
      to dual antiplatelet therapy (DAPT) (aspirin+clopidogrel : control arm representing standard&#xD;
      of care) after successful LAAC. The aim is to investigate whether rivaroxaban could provide&#xD;
      correct anticoagulation levels and adequately suppress coagulation activation after LAAC.&#xD;
&#xD;
      The patient will be enrolled after left atrial appendage closure before discharge. The&#xD;
      randomization is 1/1/1 between the 3 groups : rivaroxaban 10mg a day, rivaroxaban 15 mg a day&#xD;
      and aspirin 75mg + clopidogrel 75 mg a day. At 10 and 90 days, the patients will be sampled&#xD;
      for biological assessment : Prothrombin fragments 1+2, Factor Xa inhibitory activity, Russel&#xD;
      Viper venom enzyme assay, thrombin anti-thrombin (TAT) complex, D-Dimers, Prothrombin time&#xD;
      (Neoplastin) and plasma von Willebrand factor (vWf) Ag level&#xD;
&#xD;
      After 90 days, the patient will end his/her participation in the trial. Clinical endpoints&#xD;
      (death, MI, Stroke, TIA, systemic embolism, extracranial major bleeding or clinically&#xD;
      relevant non major bleeding) at 90 days will be assessed by a clinical endpoint committee.&#xD;
      Central echographic laboratory will review all 90 days transesophageal echocardiography (TEE)&#xD;
      to detect the presence of thrombus or peri-device leak.&#xD;
&#xD;
      The study is open-label. Central laboratory, clinical endpoint committee and echographic core&#xD;
      laboratory is blinded to randomization arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 20, 2018</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>Measure of prothrombin fragment 1 + 2</measure>
    <time_frame>at Day 10</time_frame>
    <description>Measure of prothrombin fragment 1 + 2 at Day 10 (2 to 4 hours after last intake : concentration peak)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of prothrombin fragment 1 + 2</measure>
    <time_frame>at Day 90</time_frame>
    <description>Measure of prothrombin fragment 1 + 2 at Day 90 (2 to 4 hours after last intake : concentration peak)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factor Xa inhibitory activity at day 10</measure>
    <time_frame>at Day 10</time_frame>
    <description>Factor Xa inhibitory activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factor Xa inhibitory activity at day 90</measure>
    <time_frame>at Day 90</time_frame>
    <description>Factor Xa inhibitory activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Russel Viper venom enzyme assay</measure>
    <time_frame>at Day 90</time_frame>
    <description>Russel Viper venom enzyme assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TAT complex</measure>
    <time_frame>at Day 10</time_frame>
    <description>TAT complex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TAT complex</measure>
    <time_frame>at Day 90</time_frame>
    <description>TAT complex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-Dimers</measure>
    <time_frame>at Day 10</time_frame>
    <description>D-Dimersand at peak, 2 to 4 hours after treatment intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-Dimers</measure>
    <time_frame>at Day 90</time_frame>
    <description>D-Dimersand at peak, 2 to 4 hours after treatment intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time (Neoplastin)</measure>
    <time_frame>at Day 10</time_frame>
    <description>Prothrombin time (Neoplastin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time (Neoplastin)</measure>
    <time_frame>at Day 90</time_frame>
    <description>Prothrombin time (Neoplastin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma vWf Ag level</measure>
    <time_frame>at Day 10</time_frame>
    <description>plasma vWf Ag level treatment intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma vWf Ag level</measure>
    <time_frame>at Day 90</time_frame>
    <description>plasma vWf Ag level treatment intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemorrhagic stroke and bleeding will be safety outcomes TEE with central core lab reading: presence of thrombus, peri-device leak</measure>
    <time_frame>at Day 90</time_frame>
    <description>Haemorrhagic stroke and bleeding will be safety outcomes 3-month TEE with central core lab reading: presence of thrombus, peri-device leak</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite clinical endpoint combining all clinical outcomes</measure>
    <time_frame>at Day 90</time_frame>
    <description>Composite clinical endpoint combining all clinical outcomes : Death, MI, stroke, TIA,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death (any cause)</measure>
    <time_frame>at Day 90</time_frame>
    <description>Death (any cause) assessed individually and combined at other outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction (MI)</measure>
    <time_frame>at Day 90</time_frame>
    <description>Myocardial infarction (MI) assessed individually and combined at other outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke (ischaemic stroke, haemorrhagic stroke)</measure>
    <time_frame>at Day 90</time_frame>
    <description>Stroke (ischaemic stroke, haemorrhagic stroke) assessed individually and combined at other outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transient Ischemic Attack (TIA)</measure>
    <time_frame>at Day 90</time_frame>
    <description>Transient Ischemic Attack (TIA) assessed individually and combined at other outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic embolism</measure>
    <time_frame>at Day 90</time_frame>
    <description>Systemic embolism assessed individually and combined at other outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extracranial major bleeding or clinically relevant non major bleeding (ISTH definition) at day 90</measure>
    <time_frame>at Day 90</time_frame>
    <description>Extracranial major bleeding or clinically relevant non major bleeding (ISTH definition) assessed individually and combined at other outcomes</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Atrial Appendage</condition>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>1: Rivaroxaban 10 mg qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rivaroxaban 10 mg, 1 tablet a day, from randomization to Day 90 should be taken between 8 and 10 AM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2: Rivaroxaban 15 mg qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rivaroxaban 15 mg, 1 tablet a day, from randomization to Day 90&#xD;
should be taken between 8 and 10 AM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3: DAPT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aspirin 75 mg, 1 a day Clopidogrel 75 mg, 1 tablet a day from randomization to Day 90 should be taken between 8 and 10 AM</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban 10 mg qd</intervention_name>
    <description>10mg qd</description>
    <arm_group_label>1: Rivaroxaban 10 mg qd</arm_group_label>
    <other_name>Experimental</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban 15 mg qd</intervention_name>
    <description>15mg qd</description>
    <arm_group_label>2: Rivaroxaban 15 mg qd</arm_group_label>
    <other_name>Experimental</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAPT</intervention_name>
    <description>Aspirin 75 mg qd + Clopidogrel 75 mg qd</description>
    <arm_group_label>3: DAPT</arm_group_label>
    <other_name>Active comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women ≥18 years of age&#xD;
&#xD;
          -  Patients who underwent a clinically successful LAAC procedure (device implanted&#xD;
             without procedural or bleeding complication). LAAC may have been indicated for&#xD;
             patients contraindicated or unsuitable for long-term Vitamin K antagonists (VKA)&#xD;
             anticoagulation.&#xD;
&#xD;
          -  AF (permanent or persistent or paroxysmal) patients irrespective of prior&#xD;
             antithrombotic treatment are eligible for randomization.&#xD;
&#xD;
          -  Written informed consent by the patient or designee if the patient is unable to&#xD;
             consent&#xD;
&#xD;
          -  Patients affiliated to the French social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Creatinine clearance &lt;30 mL / min (Cockcroft formula).&#xD;
&#xD;
          -  Dialysis.&#xD;
&#xD;
          -  Mechanical heart valves or valvular disease requiring surgery or interventional&#xD;
             procedure&#xD;
&#xD;
          -  Planned Ablation of AF during follow up period&#xD;
&#xD;
          -  Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single&#xD;
             anti-platelet treatment (SAPT) (e.g. high coronary risk).&#xD;
&#xD;
          -  Any contra-indication or known allergy to aspirin or clopidogrel or rivaroxaban.&#xD;
&#xD;
          -  Any mandatory indication for anticoagulation for a reason other than AF (e.g.&#xD;
             Pulmonary embolism)&#xD;
&#xD;
          -  Ongoing major bleeding or complicated or recent (&lt;72hours) major surgery&#xD;
&#xD;
          -  Known large oesophageal varices or decompensated liver disease (unless a documented&#xD;
             positive opinion of a gastro-enterologist)&#xD;
&#xD;
          -  Severe thrombocytopenia (&lt;50,000/ml) after referral to haematologist to confirm or not&#xD;
             contraindication&#xD;
&#xD;
          -  Recent myocardial infarction (&lt;6 weeks).&#xD;
&#xD;
          -  Recent cerebro-vascular event (CVE) or transient ischemic attack (&lt;6 weeks) after&#xD;
             evaluation of stroke vs bleeding risk by the referring neurologist.&#xD;
&#xD;
          -  Recent Intracranial bleeding (&lt; 6 months): these patients will be evaluated by a&#xD;
             neurologist as these patients may be considered at higher stroke risk. Neurologist may&#xD;
             consider that the LAAC procedure with a short (90 days) period of anticoagulation or&#xD;
             antiplatelet therapy as tested in the protocol is a preferable option (in that case&#xD;
             intracranial hemorrhage (ICH) will not be considered as a contraindication).&#xD;
&#xD;
          -  Prasugrel or ticagrelor concomitant use&#xD;
&#xD;
          -  Participating in an investigational drug or another device trial within the previous&#xD;
             30 days.&#xD;
&#xD;
          -  High likelihood of being unavailable for follow-up or psycho-social condition making&#xD;
             study participation impractical.&#xD;
&#xD;
          -  Woman with child bearing potential who do not use an efficient method of&#xD;
             contraception.&#xD;
&#xD;
          -  positive serum or urine pregnancy test for woman with child bearing potential&#xD;
&#xD;
          -  Pregnancy or within 48 hours post-partum or breast feeding women&#xD;
&#xD;
          -  Patient under legal protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilles MONTALESCOT, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Pitié-Salpêtrière Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Cardiologie - Hôpital Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>December 20, 2021</last_update_submitted>
  <last_update_submitted_qc>December 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Left atrial appendage closure</keyword>
  <keyword>Rivaroxaban</keyword>
  <keyword>Dual antiplatelet therapy</keyword>
  <keyword>Anticoagulation</keyword>
  <keyword>Stroke prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</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/NCT03273322
org study id: P161102J
nct id: NCT03273322
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy
      (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at
      10 and 90 days: central laboratory hemostasis analysis and clinical events assessment.
Data on antithrombotic therapy after Left Atrial Appendage Closure (LAAC) are scarce and no
      randomized evaluation has been performed to demonstrate what is the best antithrombotic
      strategy following LAAC. LAAC is classically associated with a 6-week period of
      anticoagulation with warfarin + aspirin followed by once daily clopidogrel (75 mg) + aspirin
      (81-325 mg) until the 6 months visit, then aspirin alone is continued indefinitely, as tested
      in patients without contraindication for anticoagulation in the pivotal Watchman trials. LAAC
      is mostly used in Europe as an alternative to warfarin anticoagulation when patients have a
      contraindication to or are unsuitable for warfarin anticoagulation. The classic regimen is
      not applicable and believed to be too risky in such frail patients. These patients usually
      receive a regimen of daily clopidogrel + aspirin followed by single antiplatelet therapy
      (most frequently used treatment). Some patients receive oral anticoagulation without aspirin,
      including NOAC anticoagulation. Rivaroxaban is a tempting strategy for anticoagulation
      following LAAC in atrial fibrillation (AF) patients. The dose needs first to be carefully
      evaluated the trial propose a dose ranging study in patients who have undergone successful
      LAAC.

      The study will evaluate two different Rivaroxaban regimen (10 or 15 mg a day) in comparison
      to dual antiplatelet therapy (DAPT) (aspirin+clopidogrel : control arm representing standard
      of care) after successful LAAC. The aim is to investigate whether rivaroxaban could provide
      correct anticoagulation levels and adequately suppress coagulation activation after LAAC.

      The patient will be enrolled after left atrial appendage closure before discharge. The
      randomization is 1/1/1 between the 3 groups : rivaroxaban 10mg a day, rivaroxaban 15 mg a day
      and aspirin 75mg + clopidogrel 75 mg a day. At 10 and 90 days, the patients will be sampled
      for biological assessment : Prothrombin fragments 1+2, Factor Xa inhibitory activity, Russel
      Viper venom enzyme assay, thrombin anti-thrombin (TAT) complex, D-Dimers, Prothrombin time
      (Neoplastin) and plasma von Willebrand factor (vWf) Ag level

      After 90 days, the patient will end his/her participation in the trial. Clinical endpoints
      (death, MI, Stroke, TIA, systemic embolism, extracranial major bleeding or clinically
      relevant non major bleeding) at 90 days will be assessed by a clinical endpoint committee.
      Central echographic laboratory will review all 90 days transesophageal echocardiography (TEE)
      to detect the presence of thrombus or peri-device leak.

      The study is open-label. Central laboratory, clinical endpoint committee and echographic core
      laboratory is blinded to randomization arm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Measure of prothrombin fragment 1 + 2
time frame: at Day 10
description: Measure of prothrombin fragment 1 + 2 at Day 10 (2 to 4 hours after last intake : concentration peak)
measure: Measure of prothrombin fragment 1 + 2
time frame: at Day 90
description: Measure of prothrombin fragment 1 + 2 at Day 90 (2 to 4 hours after last intake : concentration peak)
measure: Factor Xa inhibitory activity at day 10
time frame: at Day 10
description: Factor Xa inhibitory activity
measure: Factor Xa inhibitory activity at day 90
time frame: at Day 90
description: Factor Xa inhibitory activity
measure: Russel Viper venom enzyme assay
time frame: at Day 90
description: Russel Viper venom enzyme assay
measure: TAT complex
time frame: at Day 10
description: TAT complex
measure: TAT complex
time frame: at Day 90
description: TAT complex
measure: D-Dimers
time frame: at Day 10
description: D-Dimersand at peak, 2 to 4 hours after treatment intake
measure: D-Dimers
time frame: at Day 90
description: D-Dimersand at peak, 2 to 4 hours after treatment intake
measure: Prothrombin time (Neoplastin)
time frame: at Day 10
description: Prothrombin time (Neoplastin)
measure: Prothrombin time (Neoplastin)
time frame: at Day 90
description: Prothrombin time (Neoplastin)
measure: Plasma vWf Ag level
time frame: at Day 10
description: plasma vWf Ag level treatment intake
measure: Plasma vWf Ag level
time frame: at Day 90
description: plasma vWf Ag level treatment intake
measure: Haemorrhagic stroke and bleeding will be safety outcomes TEE with central core lab reading: presence of thrombus, peri-device leak
time frame: at Day 90
description: Haemorrhagic stroke and bleeding will be safety outcomes 3-month TEE with central core lab reading: presence of thrombus, peri-device leak
measure: Composite clinical endpoint combining all clinical outcomes
time frame: at Day 90
description: Composite clinical endpoint combining all clinical outcomes : Death, MI, stroke, TIA,
measure: Death (any cause)
time frame: at Day 90
description: Death (any cause) assessed individually and combined at other outcomes
measure: Myocardial infarction (MI)
time frame: at Day 90
description: Myocardial infarction (MI) assessed individually and combined at other outcomes
measure: Stroke (ischaemic stroke, haemorrhagic stroke)
time frame: at Day 90
description: Stroke (ischaemic stroke, haemorrhagic stroke) assessed individually and combined at other outcomes
measure: Transient Ischemic Attack (TIA)
time frame: at Day 90
description: Transient Ischemic Attack (TIA) assessed individually and combined at other outcomes
measure: Systemic embolism
time frame: at Day 90
description: Systemic embolism assessed individually and combined at other outcomes
measure: Extracranial major bleeding or clinically relevant non major bleeding (ISTH definition) at day 90
time frame: at Day 90
description: Extracranial major bleeding or clinically relevant non major bleeding (ISTH definition) assessed individually and combined at other outcomes
arm group label: 1: Rivaroxaban 10 mg qd
arm group type: Experimental
description: Rivaroxaban 10 mg, 1 tablet a day, from randomization to Day 90 should be taken between 8 and 10 AM
arm group label: 2: Rivaroxaban 15 mg qd
arm group type: Experimental
description: Rivaroxaban 15 mg, 1 tablet a day, from randomization to Day 90
should be taken between 8 and 10 AM
arm group label: 3: DAPT
arm group type: Active Comparator
description: Aspirin 75 mg, 1 a day Clopidogrel 75 mg, 1 tablet a day from randomization to Day 90 should be taken between 8 and 10 AM
intervention type: Drug
intervention name: Rivaroxaban 10 mg qd
description: 10mg qd
arm group label: 1: Rivaroxaban 10 mg qd
other name: Experimental
intervention type: Drug
intervention name: Rivaroxaban 15 mg qd
description: 15mg qd
arm group label: 2: Rivaroxaban 15 mg qd
other name: Experimental
intervention type: Drug
intervention name: DAPT
description: Aspirin 75 mg qd + Clopidogrel 75 mg qd
arm group label: 3: DAPT
other name: Active comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles MONTALESCOT, MD, PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Hemorrhage
mesh term: Rivaroxaban
sharing ipd: No