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

Atrial Fibrillation Clinical Trial

— WOEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769938
• Other study ID #: RDC-2008-03
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2008
• Last updated: January 12, 2013
• Start date: December 2008
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: R&D Cardiologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 573
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anticoagulants
• Atrial Fibrillation
• Platelet Aggregation Inhibitors
• Stents

Intervention

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

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst
Belgium	UZ Antwerpen	Antwerpen
Belgium	ZOL	Genk
Belgium	Maria Middelares	Gent
Belgium	UZ KU Leuven	Leuven
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	Zuiderziekenhuis	Rotterdam
Netherlands	Twee Steden Ziekenhuis	Tlibrug
Netherlands	Isala klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
R&D Cardiologie

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria).		1 year	Yes
Secondary	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	Yes

External Links

•   trial design