WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing)

R&D Cardiologie

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation; Anticoagulants; Stents; Platelet Aggregation Inhibitors

Treatments: Device: PCI (percutaneous coronary intervention)

Study type: Interventional

Funder types: Other

Identifiers

NCT00769938

RDC-2008-03

Details and patient eligibility

About

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.

Full 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

Enrollment: 573 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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573 participants in 2 patient groups

Aspirin + clopidogrel + oral anticoagulation

Active Comparator group

Treatment:

Device: PCI (percutaneous coronary intervention)

Oral anticoagulants + clopidogrel

Active Comparator group

Treatment:

Device: PCI (percutaneous coronary intervention)