Status:
COMPLETED
Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Diabetes Mellitus
Coronary Artery Disease
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief 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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00642174
Start Date
April 1 2008
End Date
January 1 2009
Last Update
February 23 2010
Active Locations (4)
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1
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
2
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
3
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
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.
Oklahoma City, Oklahoma, United States, 73104