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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

NCT ID: NCT01246011

Last Updated: 2017-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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This is a prospective, randomized, single center study. Patients scheduled for CABG will be screened and enrolled. Subjects positive for heparin/PF4 antibody within 24 h after CABG and without clinical suspicion of HIT will be randomized into one of two groups. An additional 30 patients with negative antibody titers will serve as a control group.

Conditions

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Coronary Artery Bypass Graft Surgery Presence of Heparin/Platelet Factor 4 Antibody

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Heparin PF4 antibody positive -Drug (argatroban and warfarin)

Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin

Group Type EXPERIMENTAL

Argatroban and warfarin

Intervention Type DRUG

Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month.

Heparin PF4 antibody positive no drug

Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Heparin PF4 antibody negative

Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Argatroban and warfarin

Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ik-Kyung Jang, MD, PhD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ik-Kyung Jang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2010P001386

Identifier Type: -

Identifier Source: org_study_id