A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00060554
• Other study ID #: 63133 (ASPIRE-Pilot)
• Status: Withdrawn
• Phase: Phase 2
• First received: May 7, 2003
• Last updated: November 2, 2009
• Start date: April 2003

Study information

• Verified date: November 2009
• Source: Schering-Plough
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion criteria

• Scheduled for PCI, including PCI for non-ST elevation acute coronary syndromes (ACS), primary PCI for ST elevation myocardial infarction (MI) or elective PCI (with planned overnight stay in hospital). (Patients undergoing diagnostic heart catherization who are suitable candidates for "ad hoc" PCI are also eligible).

Exclusion criteria:

• Age < 21 years

• Activated Clotting Time (ACT) > 200 seconds immediately prior to PCI

• Use of low molecular weight heparin (LMWH) in the previous 6 hours before PCI

• Currently receiving an oral anticoagulant (OAC) agent with an INR > 1.8

• Thrombolytic therapy for ST elevation MI in the previous 24 hours before PCI

• Active internal bleeding or history of hemorrhagic diathesis

• Thrombocytopenia (platelet count < 100 x 10-9/L)

• Pregnant women or women of childbearing potential who are not using an effective method of contraception

• Known allergy to unfractionated heparin, fondaparinux, aspirin or clopidogrel

• Absolute contra-indication to anticoagulation

• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment or prior participation in this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction

Intervention

Drug:
• fondaparinux sodium

• heparin

Procedure:
• percutaneous coronary intervention (PCI)

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	QE II Health Sciences Centre, New Halifax Infirmary	Halifax	Nova Scotia
Canada	HGH-McMaster Clinic	Hamilton	Ontario
Canada	Hopital du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook & Women's College Health Sciences Center	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Vancouver Hospital & Health Sciences Centre	Vancouver	British Columbia
France	Hopital Jean Minjoz	Besancon	Cedex
France	CHU de Caen	Caen	Cedex
France	Hopital du Bocage	Dijon	Cedex
France	Centre Hospitalier de Lagny-Marne La Vallee	Lagny	sur Marne
France	Hopital Bichat	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	CHU de Rangueil	Toulouse	Cedex
United States	University of Michigan, Dept. of Internal Medicine	Ann Arbor	Michigan
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Chicago - Section of Cardiology	Chicago	Illinois
United States	Greenville Hospital System	Greenville	South Carolina
United States	The Methodist Hospital	Houston	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Ocala Research Institute, Inc.	Ocala	Florida
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Schering-Plough

Countries where clinical trial is conducted

United States,  Canada,  France,