A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

This study has been withdrawn prior to enrollment.

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

First Received on May 7, 2003. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

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

Show 26 Study Locations

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

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

Keywords provided by Schering-Plough:

Elective PCI
Heart catherization
Acute coronary syndromes

Additional relevant MeSH terms:

Coronary Disease
Coronary Artery Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes

Necrosis
Fondaparinux
PENTA
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012