Ongoing WARfarin and Coronary STENTing

• Conditions: Acute Coronary Syndrome; Atrial Fibrillation

• Registration Number: NCT00722319
• Lead Sponsor: War-Stent Investigators

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-25
• Study Start: 2009-03
• Status Verified: 2010-01
• Primary Completion: 2010-07
• Last Update Submitted: 2011-08-11
• Last Update Posted: 2011-08-12
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients with ongoing warfarin treatment.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Cardiology; 🇮🇹 Bologna, Italy