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NCT00097591 · ClinicalTrials.gov registry record · Phase 3

A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
13,619
Enrollment target

NCT00097591: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT00097591 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 13,619 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1666% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00097591, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
13,619 participants
Enrollment target

Study Summary

The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.

Primary Outcome

The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).

Interventions

  • DRUG Clopidogrel
  • DRUG Prasugrel

Trial Details

FieldValue
Enrollment Target 13,619 participants
Start Date 2004-11
Est. Completion 2007-07
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00097591 record still lists

NCT00097591 is an interventional study that assigns participants to a tested intervention. Its 13,619 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1666% higher).

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

NCT00097591 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00097591 about?

NCT00097591 is a clinical study titled "A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention". The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). P...

What is the current status of trial NCT00097591?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 13,619 participants. The study started on 2004-11. Estimated completion is 2007-07.

What interventions are being tested in trial NCT00097591?

The interventions under investigation include: Clopidogrel (DRUG), Prasugrel (DRUG).

Who is sponsoring clinical trial NCT00097591?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00097591's enrollment target sits among peer trials

13,619 17th of 2000 higher than 1,984 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00097591, the US trial registry maintained by the National Library of Medicine. NCT00097591 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.