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A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

Primary Purpose

Myocardial Infarction, Coronary Disease

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fondaparinux sodium
heparin
percutaneous coronary intervention (PCI)
Sponsored by
Schering-Plough
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Elective PCI, Heart catherization, Acute coronary syndromes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ocala Research Institute, Inc.
  • University of Chicago - Section of Cardiology
  • UMass Memorial Medical Center
  • University of Michigan, Dept. of Internal Medicine
  • Greenville Hospital System
  • Vanderbilt University Medical Center
  • The Methodist Hospital
  • University of Virginia Health System
  • Foothills Hospital
  • University of Alberta Hospital
  • Vancouver Hospital & Health Sciences Centre
  • QE II Health Sciences Centre, New Halifax Infirmary
  • HGH-McMaster Clinic
  • University of Ottawa Heart Institute
  • Sunnybrook & Women's College Health Sciences Center
  • St. Michael's Hospital
  • Toronto General Hospital
  • Montreal Heart Institute
  • Hopital du Sacre-Coeur de Montreal
  • Hopital Jean Minjoz
  • CHU de Caen
  • Hopital du Bocage
  • CHU de Rangueil
  • Centre Hospitalier de Lagny-Marne La Vallee
  • Hopital Europeen Georges Pompidou
  • Hopital Bichat

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 7, 2003
Last Updated
November 2, 2009
Sponsor
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00060554
Brief Title
A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Drug sold to Sanofi-Aventis who sold it to GSK; OBS no longer owns study and does not have data.
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Schering-Plough

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Disease
Keywords
Elective PCI, Heart catherization, Acute coronary syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fondaparinux sodium
Intervention Type
Drug
Intervention Name(s)
heparin
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary intervention (PCI)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ocala Research Institute, Inc.
City
Ocala
State/Province
Florida
ZIP/Postal Code
34480
Country
United States
Facility Name
University of Chicago - Section of Cardiology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan, Dept. of Internal Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R7
Country
Canada
Facility Name
Vancouver Hospital & Health Sciences Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
QE II Health Sciences Centre, New Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
HGH-McMaster Clinic
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L81 2X2
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Sunnybrook & Women's College Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hopital Jean Minjoz
City
Besancon
State/Province
Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de Caen
City
Caen
State/Province
Cedex
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital du Bocage
City
Dijon
State/Province
Cedex
ZIP/Postal Code
21034
Country
France
Facility Name
CHU de Rangueil
City
Toulouse
State/Province
Cedex
ZIP/Postal Code
31043
Country
France
Facility Name
Centre Hospitalier de Lagny-Marne La Vallee
City
Lagny
State/Province
sur Marne
ZIP/Postal Code
77405
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

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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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