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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Sponsor:
University of Florida
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Florida
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Myocardial Infarction Diabetes Mellitus Peripheral Arterial Disease |
Interventions |
Drug: Vorapaxar Drug: Clopidogrel Drug: Aspirin |
Enrollment | 66 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Between March 2016 and October 2018, 71 patients agreed to participate in the study; 5 patients were not eligible for randomization due to the presence of an exclusion criteria. 66 patients (DM, n=30; non-DM, n=36) were exposed to at least one dose of study medication, representing the safety population. |
Arm/Group Title | Patients With Diabetes | Patients Without Diabetes |
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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. | 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. |
Period Title: Triple Therapy | ||
Started | 30 | 36 |
Completed | 29 | 32 |
Not Completed | 1 | 4 |
Reason Not Completed | ||
Adverse Event | 1 | 0 |
Withdrawal by Subject | 0 | 4 |
Period Title: Double Therapy | ||
Started | 29 | 32 |
Completed | 28 | 30 |
Not Completed | 1 | 2 |
Reason Not Completed | ||
Adverse Event | 1 | 1 |
Withdrawal by Subject | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Patients With Diabetes | Patients Without Diabetes | Total | |
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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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 30 | 34 | 64 | |
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Two patients were not compliant with medications and therefore excluded from the PD analysis. Thus, a total of 64 patients (DM, n=30; non-DM, n=34) represented the PD population of the study and were analyzed for baseline characteristics and PD data.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 30 participants | 34 participants | 64 participants | |
61 (8) | 56 (9) | 58 (10) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 30 participants | 34 participants | 64 participants | |
Female |
7 23.3%
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11 32.4%
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18 28.1%
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Male |
23 76.7%
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23 67.6%
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46 71.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 30 participants | 34 participants | 64 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
14 46.7%
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11 32.4%
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25 39.1%
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White |
15 50.0%
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22 64.7%
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37 57.8%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
1 3.3%
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1 2.9%
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2 3.1%
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chronic kidney disease
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 30 participants | 34 participants | 64 participants | |
2 6.7%
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2 5.9%
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4 6.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dominick J Angiolillo |
Organization: | University of Florida College of Medicine - Jacksonville |
Phone: | 9042443933 |
EMail: | dominick.angiolillo@jax.ufl.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT02548650 |
Other Study ID Numbers: |
IIS 53377 |
First Submitted: | September 8, 2015 |
First Posted: | September 14, 2015 |
Results First Submitted: | January 10, 2020 |
Results First Posted: | January 27, 2020 |
Last Update Posted: | February 12, 2020 |