Vorapaxar as an Add-On Antiplatelet Therapy in Patients With and Without Diabetes Mellitus (OPTIMUS-5)
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ClinicalTrials.gov Identifier: NCT02548650 |
Recruitment Status :
Completed
First Posted : September 14, 2015
Results First Posted : January 27, 2020
Last Update Posted : February 12, 2020
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Condition or disease | Intervention/treatment | Phase |
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Myocardial Infarction Diabetes Mellitus Peripheral Arterial Disease | Drug: Vorapaxar Drug: Clopidogrel Drug: Aspirin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacodynamic Effects of Vorapaxar as an Add-On Antiplatelet Therapy in Patients With and Without Diabetes Mellitus: The Optimizing Anti-Platelet Therapy In Diabetes MellitUS (OPTIMUS)-5 Study |
Actual Study Start Date : | March 25, 2016 |
Actual Primary Completion Date : | December 2018 |
Actual Study Completion Date : | February 14, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Patients with diabetes
Triple therapy (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days.
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Drug: Vorapaxar
Triple therapy with DAPT plus vorapaxar (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days
Other Name: Zontivity Drug: Clopidogrel Triple therapy with DAPT plus vorapaxar (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days
Other Name: Plavix Drug: Aspirin Triple therapy with DAPT plus vorapaxar(vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days
Other Name: ASA |
Active Comparator: Patients without diabetes
Triple therapy (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days.
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Drug: Vorapaxar
Triple therapy with DAPT plus vorapaxar (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days
Other Name: Zontivity Drug: Clopidogrel Triple therapy with DAPT plus vorapaxar (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days
Other Name: Plavix Drug: Aspirin Triple therapy with DAPT plus vorapaxar(vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days
Other Name: ASA |
- Maximal Platelet Aggregation in DM [ Time Frame: 30 days ]Comparison of maximal platelet aggregation (%) measured by light transmittance aggregometry between between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy in diabetic patients
- Maximal Platelet Aggregation in Non-DM [ Time Frame: 30 days ]Comparison of maximal platelet aggregation (%) measured by light transmittance aggregometry between between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy in non-diabetic patients

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patients with a prior MI between 2 weeks and 24 months or with PAD.
- On DAPT with low-dose aspirin (81mg od) and clopidogrel (75mg od) as per standard-of-care for at least 14 days.
- Age ≥ 18 years old.
Exclusion criteria:
- History of acute coronary syndrome in the previous 2 weeks.
- History of stroke, transient ischemic attack, or intracranial hemorrhage.
- Active pathological bleeding, history of bleeding events or increased risk of bleeding.
- Known severe hepatic impairment.
- Use of strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) or inducers (e.g., rifampin, carbamazepine, St. John's Wort and phenytoin).
- On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban).
- On treatment with any antiplatelet agent other than aspirin and clopidogrel in the past 14 days.
- Creatinine clearance <30 mL/minute.
- Platelet count <80x106/mL
- Hemoglobin <10g/dL
- Hemodynamic instability
- Pregnant females

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548650
United States, Florida | |
University of Florida | |
Jacksonville, Florida, United States, 32209 |
Principal Investigator: | Dominick J Angiolillo, MD, PhD | University of Florida College of Medicine-Jacksonville |
Documents provided by University of Florida:
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT02548650 |
Other Study ID Numbers: |
IIS 53377 |
First Posted: | September 14, 2015 Key Record Dates |
Results First Posted: | January 27, 2020 |
Last Update Posted: | February 12, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
myocardial infarction diabetes mellitus vorapaxar peripheral arterial disease |
Myocardial Infarction Peripheral Arterial Disease Peripheral Vascular Diseases Diabetes Mellitus Infarction Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Aspirin Clopidogrel Vorapaxar Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents |