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NCT01246011 · ClinicalTrials.gov registry record · Phase 4
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT01246011: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01246011 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01246011, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study 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.
Interventions
- DRUG Argatroban and warfarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01246011
The ClinicalTrials.gov registry entry for NCT01246011 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Argatroban and warfarin is the first listed.
NCT01246011 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01246011 about?
NCT01246011 is a clinical study titled "Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion". 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 argatrob...
What is the current status of trial NCT01246011?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2010-11. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01246011?
The interventions under investigation include: Argatroban and warfarin (DRUG).
Who is sponsoring clinical trial NCT01246011?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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