Phase 2
N=35
Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)
Diabetes Mellitus · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00642174 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNow™ P2Y12 Assay — 9.4; 9.3; 89.3; 27.7 percent inhibition — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- prasugrel (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNow™ P2Y12 Assay |
9.4; 9.3; 89.3; 27.7 | <0.0001 sig |
| SECONDARY Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNow™ P2Y12 Assay |
49.9; 13.4; 87.1; 29.3; 61.8; 44.2 | <0.0001 sig |
| SECONDARY Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA) |
64.9; 65.7; 33.7; 56.7; 18.0; 44.6 | 0.5466 |
| SECONDARY Platelet Reactivity Index (PRI) |
83.5; 80.6; 40.0; 76.2; 14.5; 67.5 | 0.3692 |
| SECONDARY Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate |
56.8; 58.1; 38.5; 54.8; 24.2; 48.1 | 0.5238 |
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 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 75-325 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 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.
Data sourced from ClinicalTrials.gov (NCT00642174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.