Trial Outcomes & Findings for Pharmacogenomics of Antiplatelet Response

Results Overview

ADP-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined. Higher impedance represent higher platelet aggregation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

at baseline and at 1 week

Results posted on

2017-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Clopidogrel Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily Clopidogrel: Clopidogrel 75 mg daily Aspirin: Aspirin 81 mg daily
Overall Study STARTED	19
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacogenomics of Antiplatelet Response - I

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clopidogrel n=14 Participants Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily Clopidogrel: Clopidogrel 75 mg daily Aspirin: Aspirin 81 mg daily
Age, Continuous	45.9 years STANDARD_DEVIATION 5.2 • n=99 Participants
Gender Female	6 Participants n=99 Participants
Gender Male	8 Participants n=99 Participants
Race/Ethnicity, Customized African Americans	14 participants n=99 Participants

PRIMARY outcome

Timeframe: at baseline and at 1 week

Population: Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.

ADP-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined. Higher impedance represent higher platelet aggregation.

Outcome measures

Outcome measures
Measure	Clopidogrel n=14 Participants Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily Clopidogrel: Clopidogrel 75 mg daily Aspirin: Aspirin 81 mg daily
Difference in ADP-induced Platelet Aggregation	-5.2 Difference in ohms (Post-Pre) Standard Deviation 4.1

SECONDARY outcome

Timeframe: At baseline and after 1-week

Population: Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.

Arachidonic Acid-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined

Outcome measures

Outcome measures
Measure	Clopidogrel n=14 Participants Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily Clopidogrel: Clopidogrel 75 mg daily Aspirin: Aspirin 81 mg daily
Difference in Arachidonic Acid-induced Platelet Aggregation	-5.2 Difference in ohms (Post-Pre) Standard Deviation 4.4

SECONDARY outcome

Timeframe: At Baseline and at 1 week

Population: Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding.

Collagen-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined

Outcome measures

Outcome measures
Measure	Clopidogrel n=15 Participants Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily Clopidogrel: Clopidogrel 75 mg daily Aspirin: Aspirin 81 mg daily
Difference in Collagen-induced Platelet Aggregation	-1.13 Difference in ohms (Post-Pre) Standard Deviation 4.1

SECONDARY outcome

Timeframe: At baseline and at 1 week

Population: Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding. Note that the top most gene (CNOT2) with the lowest p-value is being reported.

Platelet transcriptome will be examined before and after 1 week of therapy with clopidogrel and differences will be determined

Outcome measures

Outcome measures
Measure	Clopidogrel n=8 Participants Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily Clopidogrel: Clopidogrel 75 mg daily Aspirin: Aspirin 81 mg daily
Changes in Platelet Transcriptome With Clopidogrel	13.7 FPKM Standard Error 3.55

Adverse Events

Clopidogrel

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

Rehan Qayyum

Johns Hopkins School of Medicine

Phone: 410-955-7781

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place