Ongoing WARfarin and Coronary STENTing

Official Title: “Ongoing WARfarin and Coronary STENTing. A Multi-center, Prospective Registry on Antithrombotic Treatment.”

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.

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

Arms, Groups and Cohorts in this Clinical Trial

• : A
  • 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 Measures

• 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
    Safety Issue?: Yes

Secondary Measures

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

Inclusion Criteria:

• Patients with ongoing warfarin treatment.

Exclusion Criteria:

• None

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: War-Stent Investigators Other

Overall Clinical Trial Officials and Contacts

Andrea Rubboli, MD Study Director Division of Cardiology, Maggiore Hospital, Bologna  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00722319

Study ID Number: WS-1

ClinicalTrials.gov Identifier: NCT00722319

Health Authority: Italy: Ethics Committee