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Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3) | Clinical Trials | Clareo Health

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

A Pharmacodynamic Comparison of Prasugrel (LY640315) Versus High Dose Clopidogrel in Subjects With Type 2 Diabetes Mellitus and Coronary Artery Disease.

NCT00642174•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 74 years

Sex

ALL

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.
+3 more criteria

Locations (4)

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.

Jacksonville, Florida, United States

Worcester, Massachusetts, United States

New York, New York, United States

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

April 1, 2008

Primary Completion Date

January 1, 2009

Completion Date

January 1, 2009

Last Updated

February 23, 2010

Enrollment

ACTUAL participants

Conditions

Diabetes MellitusCoronary Artery Disease

Interventions

prasugrel

DRUG

Clopidogrel

DRUG

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

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RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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