A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting
Overview
- Phase
- Phase 3
- Intervention
- Warfarin 3mg
- Conditions
- Atrial Fibrillation
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 2725
- Locations
- 418
- Primary Endpoint
- Time to First Adjudicated ISTH MBE or CRNMBE
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Warfarin
Warfarin doses to maintain INR
Intervention: Warfarin 3mg
Dabigatran Etexilate 110mg
Patient to receive Dabigatran Etexilate 110mg twice a day (BID)
Intervention: Dabigatran Etexilate 110mg
Dabigatran Etexilate 110mg
Patient to receive Dabigatran Etexilate 110mg twice a day (BID)
Intervention: Clopidogrel or Ticagrelor
Dabigatran Etexilate 150mg
Patient to receive Dabigatran Etexilate 150mg twice a day (BID)
Intervention: Dabigatran Etexilate 150mg
Dabigatran Etexilate 150mg
Patient to receive Dabigatran Etexilate 150mg twice a day (BID)
Intervention: Clopidogrel or Ticagrelor
Warfarin
Warfarin doses to maintain INR
Intervention: Aspirin
Warfarin
Warfarin doses to maintain INR
Intervention: Clopidogrel or Ticagrelor
Warfarin
Warfarin doses to maintain INR
Intervention: Warfarin 5mg
Warfarin
Warfarin doses to maintain INR
Intervention: Warfarin 1mg
Outcomes
Primary Outcomes
Time to First Adjudicated ISTH MBE or CRNMBE
Time Frame: up to 30 months
Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial. Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status. Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.
Secondary Outcomes
- Time to First Adjudicated Stroke(up to 30 months)
- Time to First Adjudicated Unplanned Revascularisation by PCI/CABG(up to 30 months)
- Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG(up to 30 months)
- Time to Adjudicated Non-CV(up to 30 months)
- Time to First Adjudicated MI(up to 30 months)
- Time to Composite Endpoint of Death + MI + Stroke(up to 30 months)
- Time to Composite Endpoint of Death or First Thrombotic Event(up to 30 months)
- Time to Adjudicated All Cause Death(up to 30 months)
- Time to First Adjudicated SE(up to 30 months)
- Time to Adjudicated Undetermined Cause of Death(up to 30 months)
- Time to Adjudicated CV(up to 30 months)
- Time to First Adjudicated ST(up to 30 months)