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Enrollment was too slow.
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin PF4 antibody positive -Drug (argatroban and warfarin) | Experimental | Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin |
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| Heparin PF4 antibody positive no drug | No Intervention | Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication | |
| Heparin PF4 antibody negative | No Intervention | Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argatroban and warfarin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary Artery Bypass Vein Graft Patency | Vein graft patency as measured by computed tomography | Approximately 30 Days post CABG |
| Measure | Description | Time Frame |
|---|---|---|
| Major Bleeding Events. | Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin > 5 g/dL. | At 2weeks post CABG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ik-Kyung Jang, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02474 | United States |
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The study began enrolling in January 2011 and screening ended in July 2011, after it was decided that enrollment was too slow and that the study should be terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Heparin PF4 Antibody Positive no Drug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
| FG002 | Heparin PF4 Antibody Negative | Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Heparin PF4 Antibody Positive no Drug | Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication |
| BG002 | Heparin PF4 Antibody Negative | Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Coronary Artery Bypass Vein Graft Patency | Vein graft patency as measured by computed tomography | No analysis will be done due to early study termination | Posted | Approximately 30 Days post CABG |
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| Secondary | Major Bleeding Events. | Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin > 5 g/dL. | No analysis will be done due to early study termination. | Posted | At 2weeks post CABG |
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1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 0 | 0 | 0 | ||
| EG001 | Heparin PF4 Antibody Positive no Drug | Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication | 0 | 0 | 0 | 0 | ||
| EG002 | Heparin PF4 Antibody Negative | Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication | 5 | 8 | 5 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension after Coronary Artery Bypass Graft Surgery | Vascular disorders | Systematic Assessment |
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| Atrial Fibrillation after Coronary Artery Bypass Surgery | Cardiac disorders | Systematic Assessment |
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| Bleeding during or immediately after Coronary Artery Bypass Surgery | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Hematocrit after Coronary Artery Bypass Graft Surgery | Cardiac disorders | Systematic Assessment |
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| Urinary Retention after Coronary Artery Bypass Surgery | Renal and urinary disorders | Systematic Assessment |
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| Post operative nausea | Gastrointestinal disorders | Systematic Assessment |
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| Back spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pericarditis | Cardiac disorders | Systematic Assessment |
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| Parkinson's-like features | Nervous system disorders | Systematic Assessment |
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The study was ended early due to slow enrollment and results will not be analyzed. The 4 subjects who completed the study were all in the same arm of the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Philip, Data Manager | Massachusetts General Hospital | 617 726 0423 | alphilip@partners.org |
| ID | Term |
|---|---|
| C031942 | argatroban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| >=65 years |
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| Counts |
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| Participants |
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