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

Lilly

Status and phase

Completed

Phase 2

Conditions

Coronary Artery Disease

Diabetes Mellitus

Treatments

Drug: prasugrel

Drug: Clopidogrel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00642174

11241

H7T-MC-TACA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 Diabetes Mellitus and on oral or parenteral hypoglycemic therapy for at least 1 month.
History of Coronary Artery Disease with or without other types of vascular disease (such as peripheral vascular disease).
Taking Aspirin 75-325 mg/day for at least 1 week prior to randomization.
Between the ages of 18-74 years old.
If a woman of child bearing age, must not be pregnant and must agree to use reliable method of birth control during the duration of the study.

Exclusion criteria

Thienopyridine therapy within 30 days or have a defined need for thienopyridine treatment.
Coronary Artery Bypass Graft (CABG) or Percutaneous Coronary Intervention (PCI) with no stent placed within 30 days.
Planned coronary revascularization
Hemoglobin A1c (HbA1c) > or equal to 10 mg/dL within the last 3 months.
Received fibrolytic therapy <24 hours prior to randomization.
Received non-fibrin-specific fibrinolytic therapy <48 hours prior to randomization.
At risk of bleeding.
History of ischemic stroke, transient ischemic attack (TIA), intercranial neoplasm, arteriovenous malformation, or aneurysm.
Body weight <60 kilograms (kg).
International Normalized Ratio (INR) >1.5, platelet count <100,000/mm3, or anemia (hemoglobin <10 gm/dL) within 1 week of study entry.
Are receiving or will receive oral anticoagulation or antiplatelet treatment therapy.
Are being treated with daily non-steroidal anti-inflammatory drugs (NSAIDS).
Are pregnant, breast-feeding or plan to become pregnant.