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

Sponsor:	Eli Lilly and Company
Collaborator:	Daiichi Sankyo Inc.
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00642174

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Coronary Artery Disease	Drug: prasugrel Drug: Clopidogrel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	A Pharmacodynamic Comparison of Prasugrel (LY640315) Versus High Dose Clopidogrel in Subjects With Type 2 Diabetes Mellitus and Coronary Artery Disease.

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Diabetes

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Prasugrel

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Comparison of Inhibition of Platelet Aggregation (IPA) between the prasugrel and clopidogrel treatment groups assessed by Accumetrics VerifyNowTM P2Y12 Assay. [ Time Frame: 4 hours post loading dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Comparison of IPA assessed by Accumetrics VerifyNowTM P2Y12 Assay between the prasugrel and clopidogrel treatment groups. [ Time Frame: During the first 24 hours after the loading dose and 24 hours after the last maintenance dose ] [ Designated as safety issue: Yes ]
Comparison of Maximum Platelet Aggregation (MPA) between prasugrel and clopidogrel treatment groups as assessed by Light Transmittance Aggregometry (LTA) [ Time Frame: During the first 24 hours after the loading dose and 24 hours after the last maintenance dose ] [ Designated as safety issue: Yes ]
Comparison of inhibition of platelet function between prasugrel and clopidogrel treatment groups as assessed by Vasodilator-associated stimulated phosphoprotein (VASP). [ Time Frame: During the first 24 hours after the loading dose and 24 hours after the last maintenance dose ] [ Designated as safety issue: Yes ]
Comparison of inhibition of platelet function between prasugrel and clopidogrel treatment groups as measured by Thromboelastography (TEG)-platelet mapping. [ Time Frame: During the first 24 hours after the loading dose and 24 hours after the last maintenance dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	35
Study Start Date:	April 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.	Drug: prasugrel Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose.
2: Active Comparator Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.	Drug: Clopidogrel Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose.

Eligibility

Ages Eligible for Study:	18 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 75-325mg/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
HbA1c > or equal to 10mg/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 kg.
INR >1.5, platelet count <100,000/mm3, or anemia (hemoglobin <10gm/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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642174

Locations

United States, Florida
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, 32209
United States, Massachusetts
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.
Worcester, Massachusetts, United States, 01655
United States, New York
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.
New York, New York, United States, 10029
United States, Oklahoma
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.
Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

Eli Lilly and Company

Daiichi Sankyo Inc.

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT-5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11241, H7T-MC-TACA
Study First Received:	March 21, 2008
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00642174 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Hematologic Agents
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Arteriosclerosis

Pharmacologic Actions
Coronary Disease
Therapeutic Uses
Clopidogrel
Diabetes Mellitus, Type 2
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Glucose Metabolism Disorders
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010