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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: Completed Phase 4 study, sponsored by Tufts Medical Center.

NCT01789814 is a Phase 4 study that has completed, run by Tufts Medical Center. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

To document the extent of inhibition of ADP mediated platelet aggregation following the discontinuation of bivalirudin therapy in patients treated with prasugrel as compared to patients treated with clopidogrel. The percent inhibition of platelet aggregation was measured by light transmission aggregometry of platelet-rich plasma in response to P2Y12 and PAR1 and PAR4 thrombin receptor agonists at baseline and at 1, 2, 4 and 16 h following the cessation of bivalirudin infusion. Platelet response

Interventions

  • DRUG Clopidogrel
  • DRUG Prasugrel

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2013-07
Est. Completion 2014-07
Phase Phase 4
Tufts Medical Center

169 total trials

What the finished NCT01789814 record still lists

NCT01789814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Clopidogrel is the first listed.

NCT01789814 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01789814's enrollment target sits among peer trials

24 1699th of 2000 higher than 276 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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Source: ClinicalTrials.gov NCT01789814, the US trial registry maintained by the National Library of Medicine. NCT01789814 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.