Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 8, 2008
January 12, 2013
December 2008
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00769938 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing)
What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anticoagulants
  • Platelet Aggregation Inhibitors
  • Stents
  • Atrial Fibrillation
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: Aspirin + clopidogrel + oral anticoagulation
    Intervention: Device: PCI (percutaneous coronary intervention)
  • Active Comparator: Oral anticoagulants + clopidogrel
    Intervention: Device: PCI (percutaneous coronary intervention)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
573
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
 
NCT00769938
RDC-2008-03
Yes
W. Dewilde, R&D Cardiologie
R&D Cardiologie
Not Provided
Not Provided
R&D Cardiologie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP