A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

NCTId: NCT00060554

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.

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 21 Years N/A False

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.

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

fondaparinux sodium
heparin
heparin

Procedure Intervention(s)

percutaneous coronary intervention (PCI)

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status
First 15 facilities are shown on map

Clinical Research Study Facility Locations

Hopital Europeen Georges Pompidou
Paris, 75015 France

Hopital Bichat
Paris, 75018 France

Centre Hospitalier de Lagny-Marne La Vallee
Lagny, sur Marne 77405 France

CHU de Rangueil
Toulouse, Cedex 31043 France

Hopital du Bocage
Dijon, Cedex 21034 France

CHU de Caen
Caen, Cedex 14033 France

Hopital Jean Minjoz
Besancon, Cedex 25030 France

Hopital du Sacre-Coeur de Montreal
Montreal, Quebec H4J 1C5 Canada

Montreal Heart Institute
Montreal, Quebec H1T 1C8 Canada

Toronto General Hospital
Toronto, Ontario M5G 2C4 Canada

Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario M4N 3M5 Canada

St. Michael's Hospital
Toronto, Ontario M5B 1W8 Canada

University of Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7 Canada

HGH-McMaster Clinic
Hamilton, Ontario L81 2X2 Canada

QE II Health Sciences Centre, New Halifax Infirmary
Halifax, Nova Scotia B3H 3A7 Canada

Vancouver Hospital & Health Sciences Centre
Vancouver, British Columbia V5Z 1M9 Canada

University of Alberta Hospital
Edmonton, Alberta T6G 2R7 Canada

Foothills Hospital
Calgary, Alberta T2N 2T9 Canada

University of Virginia Health System
Charlottesville, Virginia 22908 United States

The Methodist Hospital
Houston, Texas 77030 United States

Vanderbilt University Medical Center
Nashville, Tennessee 37232 United States

Greenville Hospital System
Greenville, South Carolina 29605 United States

University of Michigan, Dept. of Internal Medicine
Ann Arbor, Michigan 48109 United States

UMass Memorial Medical Center
Worcester, Massachusetts 01655 United States

University of Chicago - Section of Cardiology
Chicago, Illinois 60637 United States

Ocala Research Institute, Inc.
Ocala, Florida 34480 United States

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Myocardial Infarction
  2. Coronary Disease

Other Related Condition Keywords

  1. Coronary Artery Disease
  2. Infarction

Related Intervention Keywords

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