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Anticoagulant

Fondaparinux for Coronary Bypass Graft (Fonda CABG Trial)

Phase 3

Waitlist Available

Led By Jack CJ Sun, MD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing first ever multivessel CABG-only surgery with at least 2 free grafts (e.g. Radial artery, saphenous vein, free internal mammary artery)

Age at least 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in-hospital

Awards & highlights

Fonda CABG Trial Summary

This trial will study the effect of fondaparinux on coronary graft patency, heart attack, stroke, and death in patients who have undergone coronary artery bypass grafting (CABG).

Who is the study for?

This trial is for adults at least 18 years old who are undergoing their first multivessel coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass and need at least two free grafts. It's not for those with a clear need for anticoagulation, allergies to fondaparinux or heparin, inability to consent, renal failure, or contraindications for CT angiograms.Check my eligibility

What is being tested?

The study tests the effect of fondaparinux on blood flow in bypass grafts and its impact on heart attack, stroke, venous thromboembolism, and death rates post-CABG. Safety concerns like bleeding and transfusion needs will be monitored alongside HIT antibody levels which indicate risk of developing Heparin Induced Thrombocytopenia.See study design

What are the potential side effects?

Potential side effects include bleeding risks similar to other anticoagulants but without the high risk of Heparin Induced Thrombocytopenia (HIT). There may also be a need for additional surgery due to bleeding complications.

Fonda CABG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having my first CABG surgery with at least 2 grafts.

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I am 18 years old or older.

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I am scheduled for heart bypass surgery using a heart-lung machine.

Fonda CABG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Graft patency

Secondary outcome measures

Bleeding events

Death

Myocardial infarction

+3 more

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,901 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,070,716 Total Patients Enrolled

Jack CJ Sun, MDPrincipal InvestigatorMcMaster University

1 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Fondaparinux (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT00474591 — Phase 3

Coronary Bypass Graft Research Study Groups:

Coronary Bypass Graft Clinical Trial 2023: Fondaparinux Highlights & Side Effects. Trial Name: NCT00474591 — Phase 3

Fondaparinux (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00474591 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any dangers associated with this particular course of treatment?

"This Phase 3 trial has generated data that supports the efficacy of the treatment, as well as its safety, which our team has rated a 3 on a scale from 1 to 3."

Answered by AI

Recent research and studies

Journal of Thrombosis and HaemostasisJournal

Anti-pf4/heparin Antibodies and Venous Graft Occlusion in Postcoronary Artery Bypass Surgery Patients Randomized to Postoperative Unfractionated Heparin or Fondaparinux Thromboprophylaxis

WARKENTIN, T. E., J. I. SHEPPARD, J. C. J. SUN, H. JUNG, and J. W. EIKELBOOM. 2013. “Anti-pf4/heparin Antibodies and Venous Graft Occlusion in Postcoronary Artery Bypass Surgery Patients Randomized to Postoperative Unfractionated Heparin or Fondaparinux Thromboprophylaxis”. Journal of Thrombosis and Haemostasis. Wiley. doi:10.1111/jth.12098.

clinicaltrials.govStudy

Fondaparinux to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery: The Fonda CABG Study

2024. "Fondaparinux to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery: The Fonda CABG Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00474591.