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

R&D Cardiologie573 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

573

Conditions

Anticoagulants

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (15)

UZ KU Leuven

Leuven, Leuven, Belgium

OLV Aalst

Aalst, Belgium

UZ Antwerpen

Antwerp, Belgium

ZOL

Genk, Belgium

Maria Middelares

Ghent, Belgium

MCA Alkmaar

Alkmaar, Netherlands

Academisch Medisch Centrum Amsterdam

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

...and 5 more locations

Outcomes

Primary Outcomes

The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria).

Time frame: 1 year

Secondary Outcomes

The combined event of death, myocardial infarction, stroke, systemic embolization & target vessel revascularisation and the individual components of the composite primary and secondary endpoints.