Trial Outcomes & Findings for Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia (CLI) (NCT NCT02094755)

Results Overview

Platelet inhibition to aspirin will be evaluated with the VerifyNow® aspirin (ASA) test. Clopidogrel platelet inhibition will be evaluated with two different tests: the vasodilator-stimulated phosphoprotein (VASP) and the VerifyNow® purinergic receptor P2Y12 (VN-P2Y12) assays.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

Single measurment after a minimum of one week of uninterrupted dual antiplatelet therapy with aspirin and clopidogrel

Results posted on

2019-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Single Cohort Single cohort will receive Blood draw only. Blood draw only: Blood draw only
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Cohort n=100 Participants Single cohort will receive Blood draw only. Blood draw only: Blood draw only
Age, Continuous	67.2 years STANDARD_DEVIATION 11.3 • n=100 Participants
Sex: Female, Male Female	50 Participants n=100 Participants
Sex: Female, Male Male	50 Participants n=100 Participants
Region of Enrollment United States	100 Participants n=100 Participants

PRIMARY outcome

Timeframe: Single measurment after a minimum of one week of uninterrupted dual antiplatelet therapy with aspirin and clopidogrel

Population: High on-treatment platelet reactivity on clopidigrel (HPRC) was defined as VerifyNow®P2Y12 reactive units (PRU) \>208 and VASP-platelet reactivity index (VASP-PRI) \>50%. Thromboxane A2 (TXA2) inhibition was measured with the VerifyNow®aspirin test and High on-treatment reactivity on aspirin (HPRA) was defined as aspirin reaction units (ARU) \>550.

Platelet inhibition to aspirin will be evaluated with the VerifyNow® aspirin (ASA) test. Clopidogrel platelet inhibition will be evaluated with two different tests: the vasodilator-stimulated phosphoprotein (VASP) and the VerifyNow® purinergic receptor P2Y12 (VN-P2Y12) assays.

Outcome measures

Outcome measures
Measure	Single Cohort n=100 Participants Patients were included who had a diagnosis of CLI and who received uninterrupted treatment with ASA and/or clopidogrel for ≥1 week prior to platelet inhibition testing.
Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel. HPR on Clopidogrel	18 Participants
Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel. HPR on Aspirin	17 Participants
Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel. HPR on Both	8 Participants
Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel. API on Both	57 Participants

Adverse Events

Single Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Leonardo Clavijo

University of Southern California

Phone: 3234426130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place