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NCT01789814 · ClinicalTrials.gov registry record · Phase 4
Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation
A Phase 4 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT01789814 is a Phase 4 study that has completed, run by Tufts Medical Center. The registered enrollment target is 24 participants.
The verdict
NCT01789814, a Phase 4 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
Early stent thrombosis has been noted with increased frequency in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) who are treated with bivalirudin and clopidogrel. The brief half life of bivalirudin acting in concert with the delayed action of clopidogrel likely exposes patients to thrombosis during a vulnerable period of reduced antiplatelet effect in the immediate post stenting period. Combination therapy with bivalirudin and prasugrel is conceptually attractive as the more rapid onset of action of prasugrel could potentially significantly diminish the vulnerable period, likely reducing the potential for acute stent thrombosis. The trials which have documented the efficacy of prasugrel as compared to clopidogrel have, in general, not reported on patients in whom bivalirudin was utilized. Currently, in the United States, bivalirudin is the most commonly used adjunctive agent used during PCI. Using light transmission aggregometry, this study will examine the inhibition of platelet aggregation in patients randomized to treatment with clopidogrel vs prasugrel during the vulnerable period following the discontinuation of bivalirudin therapy. The investigators anticipate that this study will document significant enhancement of inhibition of platelet aggregation in patients randomized to prasugrel treatment.
Interventions
- DRUG Clopidogrel
- DRUG Prasugrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01789814
The ClinicalTrials.gov registry entry for NCT01789814 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Clopidogrel is the first listed.
NCT01789814 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01789814 about?
NCT01789814 is a clinical study titled "Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation". Early stent thrombosis has been noted with increased frequency in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) who are treated with bivalirudin and clopidogrel. The brief half life of bivalirudin acting in concert with the delayed action of clopidogrel l...
What is the current status of trial NCT01789814?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2013-07. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01789814?
The interventions under investigation include: Clopidogrel (DRUG), Prasugrel (DRUG).
Who is sponsoring clinical trial NCT01789814?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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