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

Stopped early · Phase 4

Conditions studied: Coronary Artery Bypass Graft Surgery, Presence of Heparin/Platelet Factor 4 Antibody

In brief

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.

Key facts

Study ID

NCT01246011

Run by

Massachusetts General Hospital

People needed

9

Starts

2010-11-01

Expected to finish

2011-07-01

Last updated by the study team

2017-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients scheduled for CABG (males or non-pregnant females)
• > 18 years old with at least one vein graft planned
• Able to provide written informed consent

You may not qualify if…

• Patients who, in the investigator's or attending surgeon's opinion, are unsuitable for anticoagulation due to their clinical status
• Documented history of allergy to iodinated contrast media, warfarin, or argatroban
• Chronic renal impairment with CrCl<60 ml/min
• Recent bleeding episode
• Congestive Heart Failure (EF< 30%)
• Bleeding diathesis or known thrombophilic disorder
• Atrial fibrillation or other condition requiring anticoagulation at the time of enrollment
• Documented history of heparin induced thrombocytopenia
• 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
• Hepatic dysfunction (defined as LFTs > 3 times the upper limit of normal)
• Patients with a history of bleeding complications post-CABG
• Hemorrhagic stroke
• Gastrointestinal bleeding
• Requirement for fresh frozen plasma
• Recent central nervous system or ophthalmic surgery
• Aneurysm
• History of psychosis or senility
• Malignant hypertension
• Clinically significant pericarditis or pericardial effusion
• Bacterial endocarditis
• Hematocrit < 24%
• Valve replacement or repair at time of CABG
• Subjects with signs or symptoms of possible Transient Ischemic Attack or stroke

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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