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

Phase 4

Completed

• Conditions: Anticoagulants; Platelet Aggregation Inhibitors; Stents; Atrial Fibrillation
• Interventions: Device: PCI (percutaneous coronary intervention)

• Registration Number: NCT00769938
• Lead Sponsor: R&D Cardiologie

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

Study Timeline

• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Study Start: 2008-12
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-12
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 573

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin + clopidogrel + oral anticoagulation	PCI (percutaneous coronary intervention)	-
Oral anticoagulants + clopidogrel	PCI (percutaneous coronary intervention)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Academisch Medisch Centrum Amsterdam; 🇳🇱 Amsterdam, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

OLV Aalst; 🇧🇪 Aalst, Belgium

ZOL; 🇧🇪 Genk, Belgium

Maria Middelares; 🇧🇪 Gent, Belgium

UZ Antwerpen; 🇧🇪 Antwerpen, Belgium

UZ KU Leuven; 🇧🇪 Leuven, Belgium

MCA Alkmaar; 🇳🇱 ALkmaar, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

Sint Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Isala klinieken; 🇳🇱 Zwolle, Netherlands

OLVG; 🇳🇱 Amsterdam, Netherlands

UMCG; 🇳🇱 Groningen, Netherlands

Zuiderziekenhuis; 🇳🇱 Rotterdam, Netherlands

Twee Steden Ziekenhuis; 🇳🇱 Tlibrug, Netherlands