Trial intelligence / Profile preview

rHuEpo on Platelet Function in Healthy Subjects

NCT00368238Phase 2

Key facts

Status
Completed
Start
Oct 2005
Countries
1
Sponsor
Yale University
Modality
Biologic, rProtein (Recombinant Protein)
Conditions
myocardial infarction (MI)
01

Overview

Phase 2, randomised, double-blind trial of epoetin alfa in myocardial infarction (MI) (4 arms), sponsored by Yale University. Primary endpoints: Bleeding time and Platelet function assay closure time. Started Oct 2005; status: completed.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • rHuEpo 100 U/kg

    rHuEpo 100 U/kg daily + Aspirin + Clopidogrel

  • rHuEpo 200 U/kg

    rHuEpo 200 U/kg daily + Aspirin + Clopidogrel

  • rHuEpo 400 U/kg

    rHuEpo 400 U/kg daily + Aspirin + Clopidogrel

  • Placebo

    Placebo + Aspirin + Clopidogrel

03

Endpoints

Primary

  • Bleeding time

  • Platelet function assay closure time

Secondary

  • Complete Blood Count

  • Prothrombin Time

  • Partial Thromboplastin Time

  • P-selectin

  • von Willebrand factor

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