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Completed

NCT Number: NCT00769938

WOEST ( 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ KU Leuven, Leuven, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

    Time frame: 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.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

R&D Cardiologie

Other

Registry information

Official study title

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

Acronym: WOEST

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 9, 2008
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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