Trial Outcomes & Findings for CES1 Carriers in the PAPI Study (NCT NCT03188705)

Last Updated: 2023-06-15

Results Overview

Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation in response to ADP (20 ug/ml) or collagen (5 ug/ml). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline (recorded as a percentage) minus the maximum platelet aggregation value obtained after clopidogrel administration but before aspirin administration (also recorded as percentage). Thus, values recorded below represent a percentage change.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

Measured at baseline and after 8 days of clopidogrel treatment

Results posted on

2023-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Clopidogrel Alone Followed by Clopidogrel and Aspirin Treatment Participants will receive clopidogrel treatment alone (300 mg loading dose followed by 75 mg/d for 6 days), followed by clopidogrel (75 mg) plus aspirin (324 mg) treatment on day 8. Clopidogrel: Participants will receive 300 mg of clopidogrel on the first day, then 75 mg per day for the next 6 days. Measures of pharmacodynamics will be assessed pre- and post-drug administration. Aspirin: Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration.
Clopidogrel Treatment STARTED	6
Clopidogrel Treatment COMPLETED	5
Clopidogrel Treatment NOT COMPLETED	1
Clopidogrel Plus Aspirin Treatment STARTED	6
Clopidogrel Plus Aspirin Treatment COMPLETED	5
Clopidogrel Plus Aspirin Treatment NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Clopidogrel Alone Followed by Clopidogrel and Aspirin Treatment Participants will receive clopidogrel treatment alone (300 mg loading dose followed by 75 mg/d for 6 days), followed by clopidogrel (75 mg) plus aspirin (324 mg) treatment on day 8. Clopidogrel: Participants will receive 300 mg of clopidogrel on the first day, then 75 mg per day for the next 6 days. Measures of pharmacodynamics will be assessed pre- and post-drug administration. Aspirin: Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration.
Clopidogrel Treatment Withdrawal by Subject	1
Clopidogrel Plus Aspirin Treatment Withdrawal by Subject	1

Baseline Characteristics

CES1 Carriers in the PAPI Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clopidogrel Alone Followed by Clopidogrel and Aspirin Treatment n=5 Participants Participants will receive clopidogrel treatment alone (300 mg loading dose followed by 75 mg/d for 6 days), followed by clopidogrel (75 mg) plus aspirin (324 mg) treatment on day 8. Clopidogrel: Participants will receive 300 mg of clopidogrel on the first day, then 75 mg per day for the next 6 days. Measures of pharmacodynamics will be assessed pre- and post-drug administration. Aspirin: Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration.
Age, Continuous	47.8 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and after 8 days of clopidogrel treatment

Outcome measures

Outcome measures
Measure	Clopidogrel Alone Followed by Clopidogrel and Aspirin Treatment n=5 Participants Participants will receive clopidogrel treatment alone (300 mg loading dose followed by 75 mg/d for 6 days), followed by clopidogrel (75 mg) plus aspirin (324 mg) treatment on day 8. Clopidogrel: Participants will receive 300 mg of clopidogrel on the first day, then 75 mg per day for the next 6 days. Measures of pharmacodynamics will be assessed pre- and post-drug administration. Aspirin: Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration.
Changes in Platelet Function in Response to Clopidogrel Change in the percentage of maximal platelet aggregation in response to 20 ug/ml ADP	37.4 percentage of maximum aggregation change Standard Deviation 5.5
Changes in Platelet Function in Response to Clopidogrel Change in the percentage of maximal platelet aggregation in response to 5 ug/ml collagen	20.4 percentage of maximum aggregation change Standard Deviation 7.9

PRIMARY outcome

Timeframe: Measured at baseline and after 8 days clopidogrel administration plus 1 day of aspirin treatment

Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation in response to ADP (20 ug/ml) or collagen (5 ug/ml). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline (recorded as a percentage) minus the maximum platelet aggregation value obtained after clopidogrel and aspirin administration (also recorded as percentage). Thus, values recorded below represent a percentage change.

Outcome measures

Outcome measures
Measure	Clopidogrel Alone Followed by Clopidogrel and Aspirin Treatment n=5 Participants Participants will receive clopidogrel treatment alone (300 mg loading dose followed by 75 mg/d for 6 days), followed by clopidogrel (75 mg) plus aspirin (324 mg) treatment on day 8. Clopidogrel: Participants will receive 300 mg of clopidogrel on the first day, then 75 mg per day for the next 6 days. Measures of pharmacodynamics will be assessed pre- and post-drug administration. Aspirin: Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration.
Changes in Platelet Function in Response to Clopidogrel Plus Aspirin Change in the percentage of maximal platelet aggregation in response to 20 ug/ml ADP	38.0 percentage of max aggregation change Standard Deviation 8.2
Changes in Platelet Function in Response to Clopidogrel Plus Aspirin Change in the percentage of maximal platelet aggregation in response to 5 ug/ml collagen	55.8 percentage of max aggregation change Standard Deviation 8.8

Adverse Events

Clopidogrel Alone Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clopidogrel and Aspirin Treatment

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

Joshua P. Lewis, PhD

University of Maryland School of Medicine

Phone: 410-706-5087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place