NCT00060554

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Geographic Reach
3 countries

26 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2003

Completed
Last Updated

November 3, 2009

Status Verified

November 1, 2009

First QC Date

May 7, 2003

Last Update Submit

November 2, 2009

Conditions

Myocardial InfarctionCoronary Disease

Keywords

Elective PCIHeart catherizationAcute coronary syndromes

Interventions

fondaparinux sodiumDRUG
heparinDRUG
percutaneous coronary intervention (PCI)PROCEDURE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Ocala Research Institute, Inc.

Ocala, Florida, 34480, United States

Location

University of Chicago - Section of Cardiology

Chicago, Illinois, 60637, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Michigan, Dept. of Internal Medicine

Ann Arbor, Michigan, 48109, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2R7, Canada

Location

Vancouver Hospital & Health Sciences Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

QE II Health Sciences Centre, New Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location

HGH-McMaster Clinic

Hamilton, Ontario, L81 2X2, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Sunnybrook & Women's College Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Hopital Jean Minjoz

Besançon, Cedex, 25030, France

Location

CHU de Caen

Caen, Cedex, 14033, France

Location

Hopital du Bocage

Dijon, Cedex, 21034, France

Location

CHU de Rangueil

Toulouse, Cedex, 31043, France

Location

Centre Hospitalier de Lagny-Marne La Vallee

Lagny, Sur Marne, 77405, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

Myocardial InfarctionCoronary DiseaseAcute Coronary Syndrome

Interventions

FondaparinuxHeparinPercutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydratesGlycosaminoglycansEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2003

First Posted

May 8, 2003

Study Start

April 1, 2003

Last Updated

November 3, 2009

Record last verified: 2009-11

Locations

FR(7)US(8)CA(11)