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NCT01587651 · ClinicalTrials.gov registry record · Phase 4

Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease

A Phase 4 study, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 4
Development phase
110
Enrollment target

NCT01587651: Completed Phase 4 study, sponsored by Daiichi Sankyo.

NCT01587651 is a Phase 4 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01587651, a Phase 4 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 4
Development phase
110 participants
Enrollment target

Study Summary

This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized, 3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have previously received ticagrelor loading does (LD) and maintenance dose (MD)..

Primary Outcome

P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.

Interventions

  • DRUG Prasugrel Loading Dose
  • DRUG Prasugrel Maintenance Dose
  • DRUG Ticagrelor Maintenance Dose

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2012-03
Est. Completion 2013-02
Phase Phase 4
Daiichi Sankyo

236 total trials

What the finished NCT01587651 record still lists

NCT01587651 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 3 interventions - of which Prasugrel Loading Dose is the first listed.

NCT01587651 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01587651 about?

NCT01587651 is a clinical study titled "Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease". This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized, 3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with ticagrelor 90 mg BID (twice da...

What is the current status of trial NCT01587651?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2012-03. Estimated completion is 2013-02.

What interventions are being tested in trial NCT01587651?

The interventions under investigation include: Prasugrel Loading Dose (DRUG), Prasugrel Maintenance Dose (DRUG), Ticagrelor Maintenance Dose (DRUG).

Who is sponsoring clinical trial NCT01587651?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01587651's enrollment target sits among peer trials

110 727th of 2000 higher than 1,264 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 NCT01587651, the US trial registry maintained by the National Library of Medicine. NCT01587651 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.