A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

This study has been withdrawn prior to recruitment.

( Drug sold to Sanofi-Aventis who sold it to GSK; OBS no longer owns study and does not have data. )

First Received: May 7, 2003 Last Updated: November 2, 2009 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00060554

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction Coronary Disease	Drug: fondaparinux sodium Drug: heparin Procedure: percutaneous coronary intervention (PCI)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Coronary Artery Disease Heart Attack

Drug Information available for: ORG 31540 Fondaparinux sodium Heparin

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	300
Study Start Date:	April 2003

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060554

Hide Study Locations

Locations

United States, Florida
Ocala Research Institute, Inc.
Ocala, Florida, United States, 34480
United States, Illinois
University of Chicago - Section of Cardiology
Chicago, Illinois, United States, 60637
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan, Dept. of Internal Medicine
Ann Arbor, Michigan, United States, 48109
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2R7
Canada, British Columbia
Vancouver Hospital & Health Sciences Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
QE II Health Sciences Centre, New Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
HGH-McMaster Clinic
Hamilton, Ontario, Canada, L81 2X2
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
France
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Bichat
Paris, France, 75018
France, Cedex
Hopital Jean Minjoz
Besancon, Cedex, France, 25030
CHU de Caen
Caen, Cedex, France, 14033
CHU de Rangueil
Toulouse, Cedex, France, 31043
Hopital du Bocage
Dijon, Cedex, France, 21034
France, sur Marne
Centre Hospitalier de Lagny-Marne La Vallee
Lagny, sur Marne, France, 77405

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	63133 (ASPIRE-Pilot)
Study First Received:	May 7, 2003
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00060554 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Elective PCI
Heart catherization
Acute coronary syndromes

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Anticoagulants
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Fondaparinux
Cardiovascular Agents
Arteriosclerosis
Ischemia

Pharmacologic Actions
Org 31540
Coronary Disease
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Infarction
Myocardial Infarction
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 27, 2009