A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

Schering-Plough

Status and phase

Withdrawn

Phase 2

Conditions

Myocardial Infarction

Coronary Disease

Treatments

Drug: heparin

Drug: fondaparinux sodium

Procedure: percutaneous coronary intervention (PCI)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00060554

63133 (ASPIRE-Pilot)

Details and patient eligibility

About

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.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.