Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
Condition: Atrial Fibrillation; Percutaneous Coronary Intervention
MeSH terms: Atrial Fibrillation
Intervention: Dabigatran Etexilate 110mg; Warfarin 3mg; Aspirin; Dabigatran Etexilate 150mg; Clopidogrel or Ticagrelor; Clopidogrel or Ticagrelor; Warfarin 5mg; Clopidogrel or Ticagrelor; Warfarin 1mg
Intervention description: Active treatment; Active comparator; Active comparator; Active treatment; Active comparator; Active comparator; Active comparator; Active comparator; Active comparator
Intervention MeSH terms: Aspirin; Warfarin; Dabigatran; Clopidogrel; Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2725.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of
      110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate
      (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT)
      with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or
      ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial
      Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary
      Syndrome).

      The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT
      in terms of safety. Safety will be determined by comparing the rates of bleeding events,
      assessed using the modified International Society of Thrombosis and Haemostasis
      classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patients aged >=18 years

          -  Patients with Non Valvular Atrial Fibrillation

          -  Patient presenting with:

        An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI
        [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either
        Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at
        least one lesion eligible for PCI that was successfully treated by elective PCI and
        stenting (either BMS or DES)

          -  The patient must be able to give informed consent in accordance with International
             Conference on Harmonisation Good Clinical Practice guidelines and local legislation
             and/or regulations.

        Exclusion criteria:

          -  Patients with a mechanical or biological heart valve prosthesis

          -  Cardiogenic shock during current hospitalisation

          -  Stroke within 1 month prior to screening visit

          -  Patients who have had major surgery within the month prior to screening

          -  Gastrointestinal haemorrhage within one month prior to screening, unless, in the
             opinion of the Investigator, the cause has been permanently eliminated

          -  Major bleeding episode including life-threatening bleeding episode in one month prior
             to screening visit

          -  Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced
             thrombocytopenia (platelet count <100 x 109/L) at screening

          -  Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by
             Cockcroft-Gault equation) <30mL/min at screening

          -  Active liver disease