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Status:

COMPLETED

The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)

Lead Sponsor:

Eli Lilly and Company

Collaborating Sponsors:

Daiichi Sankyo

Conditions:

Acute Coronary Syndrome

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

Brief Summary

This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel ...

Eligibility Criteria

Inclusion

  • Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose).
  • Are between the ages of 18 and 85 years.
  • Willing and able to sign informed consent.

Exclusion

  • Have overt ST-segment elevation myocardial infarction (STEMI).
  • Have cardiogenic shock.
  • Have refractory ventricular arrhythmias.
  • Have New York Heart Association (NYHA) Class IV congestive heart failure.
  • Have severe and uncontrolled hypertension.
  • Have active internal bleeding or history of bleeding diathesis.
  • Have an increased risk of bleeding.
  • Have history of cerebrovascular accidents.
  • Have certain abnormal blood level values.
  • Are currently receiving chemotherapy or radiation therapy.

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2007

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT00385944

Start Date

March 1 2007

End Date

October 1 2007

Last Update

September 16 2010

Active Locations (2)

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Page 1 of 1 (2 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Créteil, France, 94010

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Paris, France, 75013