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

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
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 :	December 2008
Actual Primary Completion Date :	August 2012
Actual Study Completion Date :	August 2012

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. The combined event of death, myocardial infarction, stroke, systemic embolization & target vessel revascularisation and the individual components of the composite primary and secondary endpoints. [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

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Locations

Belgium
OLV Aalst
Aalst, Belgium
UZ Antwerpen
Antwerpen, Belgium
ZOL
Genk, Belgium
Maria Middelares
Gent, Belgium
UZ KU Leuven
Leuven, Belgium
Netherlands
MCA Alkmaar
ALkmaar, Netherlands
Academisch Medisch Centrum Amsterdam
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
UMCG
Groningen, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Zuiderziekenhuis
Rotterdam, Netherlands
Twee Steden Ziekenhuis
Tlibrug, Netherlands
Isala klinieken
Zwolle, Netherlands

Sponsors and Collaborators

R&D Cardiologie

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

trial design 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dewilde WJ, Janssen PW, Kelder JC, Verheugt FW, De Smet BJ, Adriaenssens T, Vrolix M, Brueren GB, Van Mieghem C, Cornelis K, Vos J, Breet NJ, ten Berg JM. Uninterrupted oral anticoagulation versus bridging in patients with long-term oral anticoagulation during percutaneous coronary intervention: subgroup analysis from the WOEST trial. EuroIntervention. 2015 Aug;11(4):381-90. doi: 10.4244/EIJY14M06_07.

Dewilde WJ, Oirbans T, Verheugt FW, Kelder JC, De Smet BJ, Herrman JP, Adriaenssens T, Vrolix M, Heestermans AA, Vis MM, Tijsen JG, van 't Hof AW, ten Berg JM; WOEST study investigators. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet. 2013 Mar 30;381(9872):1107-15. doi: 10.1016/S0140-6736(12)62177-1. Epub 2013 Feb 13.

Dewilde W, Berg JT. Design and rationale of the WOEST trial: What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing (WOEST). Am Heart J. 2009 Nov;158(5):713-8. doi: 10.1016/j.ahj.2009.09.001.

Responsible Party:	W. Dewilde, Dr, R&D Cardiologie
ClinicalTrials.gov Identifier:	NCT00769938 History of Changes
Other Study ID Numbers:	RDC-2008-03
First Posted:	October 9, 2008
Last Update Posted:	January 15, 2013
Last Verified:	January 2013

Keywords provided by W. Dewilde, R&D Cardiologie:

Atrial fibrillation; Percutaneous coronary stenting; Bleeding complications; Triple therapy

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Clopidogrel; Anticoagulants; Platelet Aggregation Inhibitors	Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs