Trial Outcomes & Findings for Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study) (NCT NCT00799396)

NCT ID: NCT00799396

Last Updated: 2022-02-24

Results Overview

Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 682 participants
• Primary outcome timeframe: Measured at baseline, and after clopidogrel treatment
• Results posted on: 2022-02-24

Participant Flow

Participant milestones

Measure	Overall Study Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment. Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment
Clopidogrel Treatment STARTED	682
Clopidogrel Treatment COMPLETED	669
Clopidogrel Treatment NOT COMPLETED	13
Clopidogrel Plus Aspirin STARTED	669
Clopidogrel Plus Aspirin COMPLETED	663
Clopidogrel Plus Aspirin NOT COMPLETED	6

Reasons for withdrawal

Measure	Overall Study Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment. Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment
Clopidogrel Treatment Adverse Event	6
Clopidogrel Treatment Physician Decision	5
Clopidogrel Treatment Withdrawal by Subject	2
Clopidogrel Plus Aspirin Adverse Event	2
Clopidogrel Plus Aspirin Physician Decision	4

Baseline Characteristics

Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)

Baseline characteristics by cohort

Measure	Overall Study n=682 Participants Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment. Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment
Age, Continuous	45.5 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	343 Participants n=5 Participants
Sex: Female, Male Male	339 Participants n=5 Participants
Region of Enrollment United States	682 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline, and after clopidogrel treatment

Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.

Outcome measures

Measure	Overall Study n=669 Participants Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment. Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation
Changes in Platelet Function in Response to Clopidogrel PRP ADP 20	38.51 percentage of maximum aggregation change Standard Deviation 14.30
Changes in Platelet Function in Response to Clopidogrel PRP Collagen 5	14.06 percentage of maximum aggregation change Standard Deviation 15.01

PRIMARY outcome

Timeframe: Measured at baseline, and after clopidogrel plus aspirin treatment

Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation

Outcome measures

Measure	Overall Study n=663 Participants Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment. Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation
Changes in Platelet Function in Response to Clopidogrel Plus Aspirin PRP ADP 20	41.21 percentage of max aggregation change Standard Deviation 13.09
Changes in Platelet Function in Response to Clopidogrel Plus Aspirin PRP Collagen 5	56.64 percentage of max aggregation change Standard Deviation 14.44

Adverse Events

Overall Study

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

Alan R Shuldiner, MD

University of Maryland School of Medicine

Phone: 410-706-1623

Email: ashuldin@medicine.umaryland.edu

Results disclosure agreements

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