A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

This study has been withdrawn prior to enrollment.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.)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00060554
First received: May 7, 2003
Last updated: November 2, 2009
Last verified: November 2009
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 September 16, 2014