Evaluation of Dual Therapy with Dabigatran vs. Triple Therapy with Warfarin in Patients with AF that undergo a PCI with Stenting

Phase 1

• Conditions: Patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting; MedDRA version: 18.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.0Level: PTClassification code 10065608Term: Percutaneous coronary interventionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003201-26-FR
• Lead Sponsor: Boehringer Ingelheim France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-23
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10500

Inclusion Criteria

- Male or female patients aged >=18 years
- Patients with Non Valvular Atrial Fibrillation
- Patient presenting with:

An ACS (STEMI, NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7220

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 CrCl calculated by Cockcroft-Gault equation) <30mL/min at screening
- Active liver disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare a dual antithrombotic treatment regimen of 110mg dabigatran etexilate twice a day (b.i.d.) plus clopidogrel or ticagrelor and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor with triple antithrombotic therapy combination of warfarin plus clopidogrel or ticagrelor plus Aspirin <= 100mg once a day (q.d.) in patients with Atrial Fibrillation (AF) that undergo a Percutaneous Coronary Intervention (PCI) with stenting.;Secondary Objective: Not applicable;Primary end point(s): 1: Time to death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE))<br><br><br>2: Time to first International Society of Thrombosis and Haemostasis Major Bleeding Event<br>;Timepoint(s) of evaluation of this end point: 1: up to 30 months<br><br>2: up to 30 months<br>