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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W. Dewilde, R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT00769938
First received: October 8, 2008
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Anticoagulants
Platelet Aggregation Inhibitors
Stents
Atrial Fibrillation
Device: PCI (percutaneous coronary intervention)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing

Resource links provided by NLM:


Further study details as provided by R&D Cardiologie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 573
Study Start Date: December 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769938

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:
No publications provided by R&D Cardiologie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: W. Dewilde, Dr, R&D Cardiologie
ClinicalTrials.gov Identifier: NCT00769938     History of Changes
Other Study ID Numbers: RDC-2008-03
Study First Received: October 8, 2008
Last Updated: January 12, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by 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
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014