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Ongoing WARfarin and Coronary STENTing

Ongoing WARfarin and Coronary STENTing. A Multi-center, Prospective Registry on Antithrombotic Treatment.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00722319
Acronym
WAR-STENT
Enrollment
1000
Registered
2008-07-25
Start date
2009-03-31
Completion date
2011-10-31
Last updated
2011-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Atrial Fibrillation

Keywords

oral anticoagulation, warfarin, percutaneous coronary intervention, stent, antiplatelet agents

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

Interventions

None listed

Sponsors

War-Stent Investigators
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with ongoing warfarin treatment.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Incidence of major/minor bleeding + adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) + arterial/venous thrombosis/thromboembolism1, 3, 6 and 12 months

Secondary

MeasureTime frame
Incidence of major/minor bleeding1, 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 thrombosis1, 3, 6 and 12 months
Arterial/venous thromboembolism;1, 3, 6 and 12 months
Blood transfusions1, 3, 6 and 12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026