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

NCT00769938 | Completed Phase 4 DMC

• 1 other identifier: RDC-2008-03
• Study Type: interventional
• Target: 573
• Locations: 2 countries
• Sites: 15

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.

Conditions

Anticoagulants; Platelet Aggregation Inhibitors; Stents; Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

  1 year

Study Arms (2)

Aspirin + clopidogrel + oral anticoagulation

ACTIVE COMPARATOR

Device: PCI (percutaneous coronary intervention)

Oral anticoagulants + clopidogrel

ACTIVE COMPARATOR

Device: PCI (percutaneous coronary intervention)

Interventions

PCI (percutaneous coronary intervention) 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

Aspirin + clopidogrel + oral anticoagulation; Oral anticoagulants + clopidogrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• R&D Cardiologie: lead

Study Sites (15)

UZ KU Leuven

Leuven, Leuven, Belgium

Location

OLV Aalst

Aalst, Belgium

Location

UZ Antwerpen

Antwerp, Belgium

Location

ZOL

Genk, Belgium

Location

Maria Middelares

Ghent, Belgium

Location

MCA Alkmaar

Alkmaar, Netherlands

Location

Academisch Medisch Centrum Amsterdam

Amsterdam, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

UMCG

Groningen, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Zuiderziekenhuis

Rotterdam, Netherlands

Location

Twee Steden Ziekenhuis

Tlibrug, Netherlands

Location

Isala klinieken

Zwolle, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 24970794 DERIVED

• 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.

  PMID: 23415013 DERIVED

• 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.

  PMID: 19853687 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: December 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

NL (10); BE (5)