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

NCT ID: NCT00769938

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 573 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-08-31

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

Conditions

Anticoagulants; Platelet Aggregation Inhibitors; Stents; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspirin + clopidogrel + oral anticoagulation

Group Type: ACTIVE_COMPARATOR

PCI (percutaneous coronary intervention)

Intervention Type: DEVICE

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

Oral anticoagulants + clopidogrel

Group Type: ACTIVE_COMPARATOR

PCI (percutaneous coronary intervention)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

R&D Cardiologie

OTHER

Sponsor Role: lead

Responsible Party

W. Dewilde

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

UMCG

Groningen, , Netherlands

Sint Antonius Ziekenhuis

Nieuwegein, , Netherlands

Zuiderziekenhuis

Rotterdam, , Netherlands

Twee Steden Ziekenhuis

Tlibrug, , Netherlands

Isala klinieken

Zwolle, , Netherlands

Countries

Belgium; Netherlands

References

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.

Reference Type: DERIVED

PMID: 24970794 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23415013 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19853687 (View on PubMed)

Other Identifiers

RDC-2008-03

Identifier Type: -

Identifier Source: org_study_id