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
- Conditions
- non-valvular atrial fibrillation and percutaneous coronary intervention1000752110014523
- Registration Number
- NL-OMON44285
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- 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.
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>See section 5.1.1 of the protocol.<br /><br><br /><br>The primary endpoint for this trial is a safety endpoint; time to first ISTH<br /><br>Major or Clinically Relevant Non-Major Bleeding Event</p><br>
- Secondary Outcome Measures
Name Time Method <p>See section 5.1.2 of the protocol.<br /><br><br /><br>The secondary endpoints of efficacy are (all time to first event):<br /><br>1. A combined endpoint of thrombotic events or death (DTE: all death + MI +<br /><br>stroke/SE) and unplanned revascularisation by PCI/CABG<br /><br>2. A combined endpoint of thrombotic events or death (DTE: all death + MI +<br /><br>stroke/SE)<br /><br>3. Individual outcome events:<br /><br>**All death (Cardiovascular, Non-cardiovascular, Undetermined)<br /><br>**MI<br /><br>**Stroke<br /><br>**SE<br /><br>**Stent thrombosis<br /><br>4. Composite endpoint of death + MI + stroke<br /><br>5. Repeated revascularisation by PCI/CABG</p><br>