A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

Sponsor

Schering-Plough (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00060554

Collaborator

(none)

300

Enrollment

Locations

11.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Coronary Disease	Drug: fondaparinux sodium Drug: heparin Procedure: percutaneous coronary intervention (PCI)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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