Trial Outcomes & Findings for Pharmacogenomics of Antiplatelet Response (NCT NCT02234427)

Results Overview

Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

2-weeks

Results posted on

2017-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Aspirin Aspirin: 2-week aspirin therapy (81mg/day)
Overall Study STARTED	34
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacogenomics of Antiplatelet Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin n=34 Participants Aspirin: 2-week aspirin therapy (81mg/day)
Age, Continuous	53.4 years STANDARD_DEVIATION 10.3 • n=5 Participants
Gender Female	17 Participants n=5 Participants
Gender Male	17 Participants n=5 Participants
Race/Ethnicity, Customized African Americans	17 participants n=5 Participants
Race/Ethnicity, Customized Caucasians	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-weeks

Population: The data were analyzed combining results from two studies (24 from this study and additional 33 individuals from study NCT01894555; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.

Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area

Outcome measures

Outcome measures
Measure	Aspirin n=57 Participants Aspirin: 2-week aspirin therapy (81mg/day)
Differential Gene Expression	77.1 FPKM for HBG1 Gene Standard Error 19.8

Adverse Events

Aspirin

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