Trial Outcomes & Findings for Vorapaxar on Thrombin Generation and Coagulability (NCT NCT03207451)

NCT ID: NCT03207451

Last Updated: 2022-08-18

Results Overview

15 μmol/L SFLLRN (PAR-1 activating peptide) induced maximum platelet aggregation at 30 days after treatment with Vorapaxar

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 81 participants
• Primary outcome timeframe: 30 days after treatment with Vorapaxar
• Results posted on: 2022-08-18

Participant Flow

Participant milestones

Measure	Vorapaxar Subjects with multiple risk factors and antiplatelet naïve to receive Vorapaxar. Vorapaxar: Vorapaxar is the principle study drug and will be given to all subjects.	Vorapaxar and Clopidogrel Subjects with 600 mg Load /75mg QD Clopidogrel QD for ≥ 7 days to receive Vorapaxar Vorapaxar and Clopidogrel: Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.	Vorapaxar and Aspirin Subjects with 81mg QD Aspirin to receive Vorapaxar Vorapaxar and Aspirin: Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.	Vorapaxar, Aspirin, and Clopidogrel Subjects with 81 mg QD Aspirin+75mg QD Clopidogrel to receive Vorapaxar. Vorapaxar, Aspirin, and Clopidogrel: Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.
Overall Study STARTED	21	8	29	23
Overall Study COMPLETED	20	8	27	20
Overall Study NOT COMPLETED	1	0	2	3

Reasons for withdrawal

Measure	Vorapaxar Subjects with multiple risk factors and antiplatelet naïve to receive Vorapaxar. Vorapaxar: Vorapaxar is the principle study drug and will be given to all subjects.	Vorapaxar and Clopidogrel Subjects with 600 mg Load /75mg QD Clopidogrel QD for ≥ 7 days to receive Vorapaxar Vorapaxar and Clopidogrel: Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.	Vorapaxar and Aspirin Subjects with 81mg QD Aspirin to receive Vorapaxar Vorapaxar and Aspirin: Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.	Vorapaxar, Aspirin, and Clopidogrel Subjects with 81 mg QD Aspirin+75mg QD Clopidogrel to receive Vorapaxar. Vorapaxar, Aspirin, and Clopidogrel: Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.
Overall Study scheduling conflict	1	0	2	2
Overall Study Adverse Event	0	0	0	1

Baseline Characteristics

Vorapaxar on Thrombin Generation and Coagulability

Baseline characteristics by cohort

Measure	Vorapaxar n=21 Participants Subjects with multiple risk factors and antiplatelet naïve to receive Vorapaxar. Vorapaxar: Vorapaxar is the principle study drug and will be given to all subjects.	Vorapaxar and Clopidogrel n=8 Participants Subjects with 600 mg Load /75mg QD Clopidogrel QD for ≥ 7 days to receive Vorapaxar Vorapaxar and Clopidogrel: Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.	Vorapaxar and Aspirin n=29 Participants Subjects with 81mg QD Aspirin to receive Vorapaxar Vorapaxar and Aspirin: Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.	Vorapaxar, Aspirin, and Clopidogrel n=23 Participants Subjects with 81 mg QD Aspirin+75mg QD Clopidogrel to receive Vorapaxar. Vorapaxar, Aspirin, and Clopidogrel: Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.	Total n=81 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 9.8 • n=5 Participants	64.2 years STANDARD_DEVIATION 9.8 • n=7 Participants	63.6 years STANDARD_DEVIATION 7.7 • n=5 Participants	64.2 years STANDARD_DEVIATION 6.7 • n=4 Participants	63.0 years STANDARD_DEVIATION 8.0 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	23 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants	17 Participants n=4 Participants	58 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 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	2 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants	17 Participants n=4 Participants	62 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	21 participants n=5 Participants	8 participants n=7 Participants	29 participants n=5 Participants	23 participants n=4 Participants	81 participants n=21 Participants

PRIMARY outcome

Timeframe: 30 days after treatment with Vorapaxar

15 μmol/L SFLLRN (PAR-1 activating peptide) induced maximum platelet aggregation at 30 days after treatment with Vorapaxar

Outcome measures

Measure	Vorapaxar n=21 Participants Subjects with multiple risk factors and antiplatelet naïve to receive Vorapaxar. Vorapaxar: Vorapaxar is the principle study drug and will be given to all subjects.	Vorapaxar and Clopidogrel n=8 Participants Subjects with 600 mg Load /75mg QD Clopidogrel QD for ≥ 7 days to receive Vorapaxar Vorapaxar and Clopidogrel: Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.	Vorapaxar and Aspirin n=29 Participants Subjects with 81mg QD Aspirin to receive Vorapaxar Vorapaxar and Aspirin: Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.	Vorapaxar, Aspirin, and Clopidogrel n=23 Participants Subjects with 81 mg QD Aspirin+75mg QD Clopidogrel to receive Vorapaxar. Vorapaxar, Aspirin, and Clopidogrel: Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.
Effects of Vorapaxar on 15 μmol/L SFLLRN (PAR-1 Activating Peptide) Induced Platelet Aggregation	8 Maximum aggregation (%) Standard Deviation 3	5 Maximum aggregation (%) Standard Deviation 2	5 Maximum aggregation (%) Standard Deviation 2	4 Maximum aggregation (%) Standard Deviation 2

PRIMARY outcome

Timeframe: 30 days after treatment with Vorapaxar

Thrombin induced platelet-fibrin clot strength (TIP-FCS) at 30 days after treatment with Vorapaxar as measured by thromboelastography.

Outcome measures

Measure	Vorapaxar n=21 Participants Subjects with multiple risk factors and antiplatelet naïve to receive Vorapaxar. Vorapaxar: Vorapaxar is the principle study drug and will be given to all subjects.	Vorapaxar and Clopidogrel n=8 Participants Subjects with 600 mg Load /75mg QD Clopidogrel QD for ≥ 7 days to receive Vorapaxar Vorapaxar and Clopidogrel: Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.	Vorapaxar and Aspirin n=29 Participants Subjects with 81mg QD Aspirin to receive Vorapaxar Vorapaxar and Aspirin: Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.	Vorapaxar, Aspirin, and Clopidogrel n=23 Participants Subjects with 81 mg QD Aspirin+75mg QD Clopidogrel to receive Vorapaxar. Vorapaxar, Aspirin, and Clopidogrel: Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.
Effects of Vorapaxar on Thrombin Induced Platelet-fibrin Clot Strength (TIP-FCS)	62.8 mm Standard Deviation 3.7	61.0 mm Standard Deviation 4.1	61.6 mm Standard Deviation 4.3	62.2 mm Standard Deviation 3.7

SECONDARY outcome

Timeframe: 30 Days after treatment with Vorapaxar

Effects of plasma von Willebrand factor (vWF) at 30 days after treatment with Vorapaxar

Outcome measures

Measure	Vorapaxar n=21 Participants Subjects with multiple risk factors and antiplatelet naïve to receive Vorapaxar. Vorapaxar: Vorapaxar is the principle study drug and will be given to all subjects.	Vorapaxar and Clopidogrel n=8 Participants Subjects with 600 mg Load /75mg QD Clopidogrel QD for ≥ 7 days to receive Vorapaxar Vorapaxar and Clopidogrel: Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.	Vorapaxar and Aspirin n=29 Participants Subjects with 81mg QD Aspirin to receive Vorapaxar Vorapaxar and Aspirin: Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.	Vorapaxar, Aspirin, and Clopidogrel n=23 Participants Subjects with 81 mg QD Aspirin+75mg QD Clopidogrel to receive Vorapaxar. Vorapaxar, Aspirin, and Clopidogrel: Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.
Effects of Vorapaxar on Von Willebrand Factor (vWF).	130 activity % Standard Deviation 36	137 activity % Standard Deviation 40	132 activity % Standard Deviation 48	137 activity % Standard Deviation 45

Adverse Events

Vorapaxar

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vorapaxar and Clopidogrel

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Vorapaxar and Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vorapaxar, Aspirin, and Clopidogrel

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vorapaxar n=21 participants at risk Subjects with multiple risk factors and antiplatelet naïve to receive Vorapaxar. Vorapaxar: Vorapaxar is the principle study drug and will be given to all subjects.	Vorapaxar and Clopidogrel n=8 participants at risk Subjects with 600 mg Load /75mg QD Clopidogrel QD for ≥ 7 days to receive Vorapaxar Vorapaxar and Clopidogrel: Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.	Vorapaxar and Aspirin n=29 participants at risk Subjects with 81mg QD Aspirin to receive Vorapaxar Vorapaxar and Aspirin: Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.	Vorapaxar, Aspirin, and Clopidogrel n=23 participants at risk Subjects with 81 mg QD Aspirin+75mg QD Clopidogrel to receive Vorapaxar. Vorapaxar, Aspirin, and Clopidogrel: Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.
Gastrointestinal disorders Bleeding	0.00% 0/21 • Safety assessments for this trial included adverse events (AEs) including bleeding after the first administration of study treatment through the end of participation in the study (60 days from start of Vorapaxar).	0.00% 0/8 • Safety assessments for this trial included adverse events (AEs) including bleeding after the first administration of study treatment through the end of participation in the study (60 days from start of Vorapaxar).	0.00% 0/29 • Safety assessments for this trial included adverse events (AEs) including bleeding after the first administration of study treatment through the end of participation in the study (60 days from start of Vorapaxar).	4.3% 1/23 • Safety assessments for this trial included adverse events (AEs) including bleeding after the first administration of study treatment through the end of participation in the study (60 days from start of Vorapaxar).

Other adverse events

Measure	Vorapaxar n=21 participants at risk Subjects with multiple risk factors and antiplatelet naïve to receive Vorapaxar. Vorapaxar: Vorapaxar is the principle study drug and will be given to all subjects.	Vorapaxar and Clopidogrel n=8 participants at risk Subjects with 600 mg Load /75mg QD Clopidogrel QD for ≥ 7 days to receive Vorapaxar Vorapaxar and Clopidogrel: Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.	Vorapaxar and Aspirin n=29 participants at risk Subjects with 81mg QD Aspirin to receive Vorapaxar Vorapaxar and Aspirin: Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.	Vorapaxar, Aspirin, and Clopidogrel n=23 participants at risk Subjects with 81 mg QD Aspirin+75mg QD Clopidogrel to receive Vorapaxar. Vorapaxar, Aspirin, and Clopidogrel: Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.
Skin and subcutaneous tissue disorders minor bleeding	0.00% 0/21 • Safety assessments for this trial included adverse events (AEs) including bleeding after the first administration of study treatment through the end of participation in the study (60 days from start of Vorapaxar).	25.0% 2/8 • Number of events 2 • Safety assessments for this trial included adverse events (AEs) including bleeding after the first administration of study treatment through the end of participation in the study (60 days from start of Vorapaxar).	0.00% 0/29 • Safety assessments for this trial included adverse events (AEs) including bleeding after the first administration of study treatment through the end of participation in the study (60 days from start of Vorapaxar).	30.4% 7/23 • Number of events 7 • Safety assessments for this trial included adverse events (AEs) including bleeding after the first administration of study treatment through the end of participation in the study (60 days from start of Vorapaxar).

Additional Information

Director of Clinical Trials

Inova Health System

Phone: 443-244-1497

Email: kevin.bliden@inova.org

Results disclosure agreements

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