WithdrawnPhase 2

A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

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

United States, Canada, France300 participantsStarted 2003-04

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00060554

SponsorSchering-Plough

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Myocardial Infarction trials