Patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting MedDRA version: 19.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders MedDRA version: 19.0 Level: PT Classification code 10065608 Term: Percutaneous coronary intervention System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Pradaxa
Product Name: dabigatran etexilate, 110 mg
Product Code: BIBR 1048 MS
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DABIGATRAN ETEXILATE MESILATE
Other descriptive nam
Sponsors
Boehringer Ingelheim AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2127
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 first ISTH Major or Clinically Relevant Non-Major Bleeding Event ;Timepoint(s) of evaluation of this end point: 1: up to 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Time to event for thrombotic events or death (DTE: all death + MI + stroke/SE) and unplanned revascularisation by PCI/CABG 2: Time to event for thrombotic events or death (DTE: all death + MI + stroke/SE) 3: Time to event for individual outcome events: - All death (Cardiovascular death, Non-cardiovascular death, Undetermined) 4: Time to event for individual outcome events: - MI 5: Time to event for individual outcome events: - Stroke 6: Time to event for individual outcome events: - SE 7: Time to event for individual outcome events: - Stent Thrombosis 8: Time to event for death + MI + stroke 9: Time to unplanned revascularisation by PCI/CABG ;Timepoint(s) of evaluation of this end point: 1: up to 30 months 2: up to 30 months 3: up to 30 months 4: up to 30 months 5: up to 30 months 6: up to 30 months 7: up to 30 months 8: up to 30 months 9: up to 30 months | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, Slovenia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactQPRE pSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co.KG
Outcome results
None listed