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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Patients With Diabetes Patients Without Diabetes Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 30 participants 34 participants 64 participants
Female
7
  23.3%
11
  32.4%
18
  28.1%
Male
23
  76.7%
23
  67.6%
46
  71.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 34 participants 64 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
  46.7%
11
  32.4%
25
  39.1%
White
15
  50.0%
22
  64.7%
37
  57.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.3%
1
   2.9%
2
   3.1%
chronic kidney disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 34 participants 64 participants
2
   6.7%
2
   5.9%
4
   6.3%
1.Primary Outcome
Title Maximal Platelet Aggregation in DM
Hide Description 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
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
The PD population included all patients with PD data and without a major protocol deviation thought to affect the PD effects of vorapaxar, aspirin and clopidogrel. Two patients were not compliant with medications and therefore excluded from the PD analysis. Some patients did not have primary end point data but were considered for other analyses.
Arm/Group Title Triple Therapy Dual Therapy
Hide Arm/Group Description:
vorapaxar plus DAPT
(vorapaxar plus clopidogrel)
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percentage of aggregation
65  (20) 78  (20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triple Therapy, Dual Therapy
Comments The primary end point of our study was the comparison of CAT-induced MPA measured by LTA between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy. We hypothesized that dual therapy would be non-inferior to triple therapy after 30±5 days of treatment
Type of Statistical Test Non-Inferiority
Comments Under the null hypothesis that the mean aggregation between dual and triple therapy is not equal to 0 and a common standard deviation of 13%, a sample size of 28 patients per group with a valid primary end point time point allowed for the 95% confidence interval (CI) to stay within ± 10% with a 80% power and a two-sided alpha=0.05.
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 12
Confidence Interval (2-Sided) 95%
3 to 21
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Maximal Platelet Aggregation in Non-DM
Hide Description 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
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triple Therapy Dual Therapy
Hide Arm/Group Description:
vorapaxar plus DAPT
(vorapaxar plus clopidogrel)
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: percentage of aggregation
60  (15) 70  (20)
Time Frame Study duration (60 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Diabetes Patients Without Diabetes
Hide Arm/Group Description 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.
All-Cause Mortality
Patients With Diabetes Patients Without Diabetes
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/36 (0.00%)    
Hide Serious Adverse Events
Patients With Diabetes Patients Without Diabetes
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/36 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With Diabetes Patients Without Diabetes
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/30 (6.67%)      2/36 (5.56%)    
Blood and lymphatic system disorders     
minor bleeding * [1]  1/30 (3.33%)  1 0/36 (0.00%)  0
Cardiac disorders     
Chest pain * [2]  1/30 (3.33%)  1 2/36 (5.56%)  2
*
Indicates events were collected by non-systematic assessment
[1]
hematuria
[2]
chest pain not requiring intervention
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dominick J Angiolillo
Organization: University of Florida College of Medicine - Jacksonville
Phone: 9042443933
EMail: dominick.angiolillo@jax.ufl.edu
Layout table for additonal information
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