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

Sponsor

R&D Cardiologie (Other)

Overall Status

Completed

CT.gov ID

NCT00769938

Collaborator

(none)

573

Enrollment

Locations

Arms

Duration (Months)

38.2

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulants Platelet Aggregation Inhibitors Stents Atrial Fibrillation	Device: PCI (percutaneous coronary intervention)	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

573 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aspirin + clopidogrel + oral anticoagulation	Device: PCI (percutaneous coronary intervention) 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
Active Comparator: Oral anticoagulants + clopidogrel	Device: PCI (percutaneous coronary intervention) 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

Arm

Intervention/Treatment

Active Comparator: Aspirin + clopidogrel + oral anticoagulation

Device: PCI (percutaneous coronary intervention)

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

Active Comparator: Oral anticoagulants + clopidogrel

Device: PCI (percutaneous coronary intervention)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	OLV Aalst	Aalst	Belgium
2	UZ Antwerpen	Antwerpen	Belgium
3	ZOL	Genk	Belgium
4	Maria Middelares	Gent	Belgium
5	UZ KU Leuven	Leuven	Belgium
6	MCA Alkmaar	ALkmaar	Netherlands
7	Academisch Medisch Centrum Amsterdam	Amsterdam	Netherlands
8	OLVG	Amsterdam	Netherlands
9	Amphia Ziekenhuis	Breda	Netherlands
10	Catharina Ziekenhuis	Eindhoven	Netherlands
11	UMCG	Groningen	Netherlands
12	Sint Antonius Ziekenhuis	Nieuwegein	Netherlands	3435 CM
13	Zuiderziekenhuis	Rotterdam	Netherlands
14	Twee Steden Ziekenhuis	Tlibrug	Netherlands
15	Isala klinieken	Zwolle	Netherlands