Clinical trial NCT00060554: A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Myocardial Infarction
Coronary Disease
Keywords: Elective PCI
Heart catherization
Acute coronary syndromes
Lead sponsor: Schering-Plough
Sponsor class: INDUSTRY
First posted: 2003-05-08
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

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