Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Coronary Artery Disease
Intervention: prasugrel (Drug); Clopidogrel (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT-5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Overall contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559
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.
Clinical Details
Official title: A Pharmacodynamic Comparison of Prasugrel (LY640315) Versus High Dose Clopidogrel in Subjects With Type 2 Diabetes Mellitus and Coronary Artery Disease.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Comparison of Inhibition of Platelet Aggregation (IPA) between the prasugrel and clopidogrel treatment groups assessed by Accumetrics VerifyNowTM P2Y12 Assay.
Secondary outcome: Comparison of IPA assessed by Accumetrics VerifyNowTM P2Y12 Assay between the prasugrel and clopidogrel treatment groups.Comparison of Maximum Platelet Aggregation (MPA) between prasugrel and clopidogrel treatment groups as assessed by Light Transmittance Aggregometry (LTA) Comparison of inhibition of platelet function between prasugrel and clopidogrel treatment groups as assessed by Vasodilator-associated stimulated phosphoprotein (VASP). Comparison of inhibition of platelet function between prasugrel and clopidogrel treatment groups as measured by Thromboelastography (TEG)-platelet mapping.
Eligibility
Minimum age: 18 Years.
Maximum age: 74 Years.
Gender(s): Both.
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.
Locations and Contacts
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559
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 32209, United States; Recruiting
Eli Lilly
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 01655, United States; Recruiting
Eli Lilly
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 10029, United States; Recruiting
Eli Lilly
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 73104, United States; Recruiting
Eli Lilly
Additional Information
Lilly Clinical Trial Registry
Starting date: April 2008
Ending date: January 2009
Last updated: May 13, 2008
|
