Overview

Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)

Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. The study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who have coronary artery disease. Various assays of platelet function will be used in this study. Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12, Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein (VASP), and Thromboelastography (TEG)-platelet mapping.
Phase:
Phase 2
Details
Lead Sponsor:
Eli Lilly and Company
Collaborators:
Daiichi Sankyo Inc.
Daiichi Sankyo, Inc.
Treatments:
Clopidogrel
Prasugrel Hydrochloride
Ticlopidine