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Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Bypass Graft Surgery; Presence of Heparin/Platelet Factor 4 Antibody

Intervention: Argatroban and warfarin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Ik-Kyung Jang, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

Summary

Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with a negative antibody result will also be followed in the study. All subjects will have a cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery bypass vein grafts. This study will evaluate if treating patients who have heparin PF4 antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of coronary artery bypass vein grafts.

Clinical Details

Official title: Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Primary outcome: Coronary Artery Bypass Vein Graft Patency

Secondary outcome: Major Bleeding Events.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients scheduled for CABG (males or non-pregnant females) 2. > 18 years old with at least one vein graft planned 3. Able to provide written informed consent Exclusion Criteria: 1. Patients who, in the investigator's or attending surgeon's opinion, are unsuitable for anticoagulation due to their clinical status 2. Documented history of allergy to iodinated contrast media, warfarin, or argatroban 3. Chronic renal impairment with CrCl<60 ml/min 4. Recent bleeding episode 5. Congestive Heart Failure (EF< 30%) 6. Bleeding diathesis or known thrombophilic disorder 7. Atrial fibrillation or other condition requiring anticoagulation at the time of enrollment 8. Documented history of heparin induced thrombocytopenia 9. Clinical suspicion of HIT at the time of randomization, defined as 50% decrease in Platelet count from last heparin exposure or Platelet count <100,000/ml 10. Hepatic dysfunction (defined as LFTs > 3 times the upper limit of normal) 11. Patients with a history of bleeding complications post-CABG 12. Hemorrhagic stroke 13. Gastrointestinal bleeding 14. Requirement for fresh frozen plasma 15. Recent central nervous system or ophthalmic surgery 16. Aneurysm 17. History of psychosis or senility 18. Malignant hypertension 19. Clinically significant pericarditis or pericardial effusion 20. Bacterial endocarditis 21. Hematocrit < 24% 22. Valve replacement or repair at time of CABG 23. Subjects with signs or symptoms of possible Transient Ischemic Attack or stroke

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02474, United States
Additional Information

Starting date: November 2010
Last updated: March 9, 2012

Page last updated: August 23, 2015

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