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Ongoing WARfarin and Coronary STENTing (WAR-STENT)

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ClinicalTrials.gov Identifier: NCT00722319
Recruitment Status : Unknown
Verified January 2010 by War-Stent Investigators.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2008
Last Update Posted : August 12, 2011
Sponsor:
Information provided by:
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.

Condition or disease
Acute Coronary Syndrome Atrial Fibrillation

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 Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ongoing WARfarin and Coronary STENTing. A Multi-center, Prospective Registry on Antithrombotic Treatment.
Study Start Date : March 2009
Actual Primary Completion Date : July 2010
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort
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 Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of major/minor bleeding [ Time Frame: 1, 3, 6 and 12 months ]
  2. Adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) [ Time Frame: 1, 3, 6 and 12 months ]
  3. Stent thrombosis [ Time Frame: 1, 3, 6 and 12 months ]
  4. Arterial/venous thromboembolism; [ Time Frame: 1, 3, 6 and 12 months ]
  5. Blood transfusions [ Time Frame: 1, 3, 6 and 12 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated with warfarin who are hospitalized at tertiary centers all over the country to undergo percutaneous coronary intervention with stent implantation
Criteria

Inclusion Criteria:

  • Patients with ongoing warfarin treatment.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722319


Locations
Italy
Division of Cardiology
Bologna, Italy, 40133
Sponsors and Collaborators
War-Stent Investigators
Investigators
Study Director: Andrea Rubboli, MD Division of Cardiology, Maggiore Hospital, Bologna

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Aldo P. Maggioni, Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO)
ClinicalTrials.gov Identifier: NCT00722319     History of Changes
Other Study ID Numbers: WS-1
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: January 2010

Keywords provided by War-Stent Investigators:
oral anticoagulation
warfarin
percutaneous coronary intervention
stent
antiplatelet agents

Additional relevant MeSH terms:
Atrial Fibrillation
Acute Coronary Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Warfarin
Anticoagulants