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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). 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.
Primary Outcome
Vein graft patency as measured by computed tomography
Interventions
- DRUG Argatroban and warfarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
Why NCT01246011 stopped before completion
NCT01246011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Argatroban and warfarin is the first listed.
NCT01246011 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01246011's enrollment target sits among peer trials
9 1968th of 2000 higher than 29 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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