CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 13,619 enrolled
Drug / intervention
Prasugrel +1 moredrug
Likely dose
Prasugrel and clopidogrel dosing not specified in the provided textAI-extracted
Key inclusion· 2
  • ✓Diagnosed with acute coronary syndrome and scheduled for percutaneous coronary intervention
  • ✓Age ≥18 years and mentally competent
Key exclusion· 5
  • ✕Ischemic stroke within 3 months or any prior hemorrhagic stroke
  • ✕Active internal bleeding or history of bleeding disorder
  • ✕Increased bleeding risk based on lab criteria or medications that cause bleeding
  • ✕Liver disease (e.g., cirrhosis)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00097591
NCT00097591Phase 3Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Nov 25, 2004·Updated Sep 16, 2010

In Brief

A Phase 3 clinical trial evaluating Prasugrel and Clopidogrel for Coronary Arteriosclerosis and Acute Coronary Syndromes. Completed, enrolled 13,619 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Arteriosclerosis, Acute Coronary Syndromes
CountriesUnited States
CollaboratorsDaiichi Sankyo

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 25, 2004
Enrollment StartNov 1, 2004
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 21.6 years ago

Interventions

Prasugreldrug

Administered orally

Clopidogreldrug

Administered orally