Ongoing WARfarin and Coronary STENTing (WAR-STENT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by War-Stent Investigators.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
War-Stent Investigators
ClinicalTrials.gov Identifier:
NCT00722319
First received: July 23, 2008
Last updated: August 11, 2011
Last verified: January 2010
  Purpose

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
Acute Coronary Syndrome
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ongoing WARfarin and Coronary STENTing. A Multi-center, Prospective Registry on Antithrombotic Treatment.

Resource links provided by NLM:


Further study details as provided by War-Stent Investigators:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of major/minor bleeding [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Arterial/venous thromboembolism; [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Blood transfusions [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: March 2009
Estimated Study Completion Date: October 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Additional 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
Study First Received: July 23, 2008
Last Updated: August 11, 2011
Health Authority: Italy: Ethics Committee

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
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Platelet Aggregation Inhibitors
Warfarin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on July 23, 2014