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A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

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ClinicalTrials.gov Identifier: NCT00060554
Recruitment Status : Withdrawn (Drug sold to Sanofi-Aventis who sold it to GSK; OBS no longer owns study and does not have data.)
First Posted : May 8, 2003
Last Update Posted : November 3, 2009
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : April 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060554


  Show 26 Study Locations
Sponsors and Collaborators
Schering-Plough
More Information

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)
First Posted: May 8, 2003    Key Record Dates
Last Update Posted: November 3, 2009
Last Verified: November 2009

Keywords provided by Schering-Plough:
Elective PCI
Heart catherization
Acute coronary syndromes

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Fondaparinux
PENTA
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors