Anticoagulants, Atrial Fibrillation, Platelet Aggregation Inhibitors, Stents
Conditions
Keywords
Atrial fibrillation, Percutaneous coronary stenting, Bleeding complications, Triple therapy
Brief summary
The study will assess the hypothesis that the combination warfarin & clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect to the prevention of thrombotic complications in patients with both indications for warfarin use and dual antiplatelet (clopidogrel 75mg/day + aspirin 80mg/day) treatment.
Detailed description
Chronic oral antithrombotic treatment is necessary in patients with mechanical heart valves and in the majority of patients with atrial fibrillation. When these patients have to undergo Percutaneous Coronary Intervention (PCI) with stenting, there is also an indication for treatment with aspirin and clopidogrel. However, triple therapy is known to augment the risk for bleeding complications.Unfortunately, no prospective data are available to solve this issue. Nevertheless, it all comes down to finding the ideal therapy in patients with both atrial fibrillation and percutaneous intervention to prevent thrombotic complications (e.g. stent thrombosis) without increasing the risk of bleeding. This prospective randomised study will assess the hypothesis that in patients on warfarin therapy and indication for elective percutaneous intervention, the combination warfarin & clopidogrel 75 mg/day is superior to triple therapy treatment in reducing the risk of bleeds while equally safe with respect to the prevention of thrombotic complications
Interventions
only patients scheduled for PCI can be included tough this intervention would also take place without this study. What we want to study is the difference in outcome after a little change in the antithrombotic treatment
Sponsors
R&D Cardiologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients is on oral anticoagulation therapy and this will be continued throughout the period of 1 year-and deployment of at least 1 coronary stent (bare metal stent (BMS) or drug eluting stent (DES)). -age of more than 18 years
Exclusion criteria
* cardiogenic shock, * contra-indication for aspirin or clopidogrel * allergy to aspirin or clopidogrel, * documented peptic ulcer disease within the previous six months, * pregnancy and * previous intracerebral haemorrhage or * significant thrombocytopenia (platelet count \< 50x10 9/L). * major bleeding according to timi criteria within the past 12 months * age \> 80 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria). | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| The combined event of death, myocardial infarction, stroke, systemic embolization & target vessel revascularisation and the individual components of the composite primary and secondary endpoints. | 1 year |
Countries
Belgium, Netherlands
Outcome results
None listed