Overview

This trial is active, not recruiting.

Conditions acute coronary syndrome, atrial fibrillation
Sponsor War-Stent Investigators
Start date March 2009
End date July 2010
Trial size 1000 participants
Trial identifier NCT00722319, WS-1

Summary

Patients on warfarin treatment pose particular problems when undergoing percutaneous coronary intervention with stent implantation (PCI-S), because of the poor definition of the optimal antithrombotic strategies to be adopted both peri-procedurally and during the 4 (or more) weeks after PCI-S, when dual antiplatelet therapy with aspirin and clopidogrel is recommended. In the absence of solid evidence-based data, no definite recommendations for the management of this patient subset are currently given in the guidelines on percutaneous coronary intervention issued by the most prominent Cardiology Associations. Indeed, a high variability has been reported in the current antithrombotic strategies, which may consist in either the temporary substitution of warfarin by dual antiplatelet treatment or the combination of warfarin and aspirin or clopidogrel or both. Peri-procedural bridging therapy with either intravenous unfractionated or subcutaneous low-molecular-weight heparin is also variably carried out. Purpose of this registry is to determine in patients on warfarin treatment undergoing PCI-S: 1) the contemporary peri-procedural and medium-term antithrombotic management; and 2) the relative safety and efficacy of the various antithrombotic regimens.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients on long-term oral anticoagulation who are submitted to PCI-S because of acute coronary syndrome or stable angina. No further groups nor interventions are anticipated since the study is observational

Primary Outcomes

Measure
Incidence of major/minor bleeding + adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) + arterial/venous thrombosis/thromboembolism
time frame: 1, 3, 6 and 12 months

Secondary Outcomes

Measure
Incidence of major/minor bleeding
time frame: 1, 3, 6 and 12 months
Adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death)
time frame: 1, 3, 6 and 12 months
Stent thrombosis
time frame: 1, 3, 6 and 12 months
Arterial/venous thromboembolism;
time frame: 1, 3, 6 and 12 months
Blood transfusions
time frame: 1, 3, 6 and 12 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients with ongoing warfarin treatment. Exclusion Criteria: - None

Additional Information

Official title Ongoing WARfarin and Coronary STENTing. A Multi-center, Prospective Registry on Antithrombotic Treatment.
Description Patients on oral anticoagulation with vitamin-K antagonists who undergo PCI-S will be prospectively included in the registry and follow up for 12 months
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by War-Stent Investigators.