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

• ClinicalTrials.gov Identifier: NCT00769938
• Recruitment Status: Completed
• First Posted: October 9, 2008
• Last Update Posted: January 15, 2013
• Sponsor: R&D Cardiologie
• Information provided by (Responsible Party): W. Dewilde, R&D Cardiologie

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 (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

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

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

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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

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
• 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