WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing)
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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 |
- 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 ]
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00769938
| 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 | |
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 Cardiovascular Diseases Heart Diseases Pathologic Processes |
Anticoagulants Hematologic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015