Trial Outcomes & Findings for Vorapaxar as an Add-On Antiplatelet Therapy in Patients With and Without Diabetes Mellitus (NCT NCT02548650)

NCT ID: NCT02548650

Last Updated: 2020-02-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 66 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2020-02-12

Participant Flow

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.

Participant milestones

Measure	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.	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.
Triple Therapy STARTED	30	36
Triple Therapy COMPLETED	29	32
Triple Therapy NOT COMPLETED	1	4
Double Therapy STARTED	29	32
Double Therapy COMPLETED	28	30
Double Therapy NOT COMPLETED	1	2

Reasons for withdrawal

Measure	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.	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.
Triple Therapy Adverse Event	1	0
Triple Therapy Withdrawal by Subject	0	4
Double Therapy Adverse Event	1	1
Double Therapy Withdrawal by Subject	0	1

Baseline Characteristics

Vorapaxar as an Add-On Antiplatelet Therapy in Patients With and Without Diabetes Mellitus

Baseline characteristics by cohort

Measure	Patients With Diabetes n=30 Participants 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.	Patients Without Diabetes n=34 Participants 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 n=64 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 8 • n=5 Participants	56 years STANDARD_DEVIATION 9 • n=7 Participants	58 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
chronic kidney disease	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: 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.

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

Outcome measures

Measure	Triple Therapy n=30 Participants vorapaxar plus DAPT	Dual Therapy n=30 Participants (vorapaxar plus clopidogrel)
Maximal Platelet Aggregation in DM	65 percentage of aggregation Standard Deviation 20	78 percentage of aggregation Standard Deviation 20

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Triple Therapy n=34 Participants vorapaxar plus DAPT	Dual Therapy n=34 Participants (vorapaxar plus clopidogrel)
Maximal Platelet Aggregation in Non-DM	60 percentage of aggregation Standard Deviation 15	70 percentage of aggregation Standard Deviation 20

Adverse Events

Patients With Diabetes

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Patients Without Diabetes

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Patients With Diabetes n=30 participants at risk 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.	Patients Without Diabetes n=36 participants at risk 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.
Blood and lymphatic system disorders minor bleeding	3.3% 1/30 • Number of events 1 • Study duration (60 days)	0.00% 0/36 • Study duration (60 days)
Cardiac disorders Chest pain	3.3% 1/30 • Number of events 1 • Study duration (60 days)	5.6% 2/36 • Number of events 2 • Study duration (60 days)

Additional Information

Dominick J Angiolillo

University of Florida College of Medicine - Jacksonville

Phone: 9042443933

Email: dominick.angiolillo@jax.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place