An observational study in Acute Coronary Syndrome and Atrial Fibrillation, sponsored by War-Stent Investigators. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2011-08-12.
Sponsored by War-Stent Investigators · Observational
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
3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 300 across 1,362 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with War-Stent Investigators as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients treated with warfarin who are hospitalized at tertiary centers all over the country to undergo percutaneous coronary intervention with stent implantation
Exclusion Criteria:
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
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
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
This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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