Trial Outcomes & Findings for Pharmacogenomics of Antiplatelet Response - II (PARes-II) (NCT NCT01894555)

NCT ID: NCT01894555

Last Updated: 2017-01-09

Results Overview

Comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after 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: 33 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2017-01-09

Participant Flow

Participant milestones

Measure	Aspirin Participants treated with aspirin - there is no control group. Participant's baseline will act as their control. Aspirin: 81 mg daily for 4 weeks
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacogenomics of Antiplatelet Response - II (PARes-II)

Baseline characteristics by cohort

Measure	Aspirin n=33 Participants Participants treated with aspirin - there is no control group. Participant's baseline will act as their control. Aspirin: 81 mg daily for 4 weeks
Age, Continuous	50.6 years STANDARD_DEVIATION 8.0 • n=5 Participants
Gender Female	15 Participants n=5 Participants
Gender Male	18 Participants n=5 Participants
Race/Ethnicity, Customized African Americans	22 participants n=5 Participants
Race/Ethnicity, Customized Caucasians	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: The data were analyzed combining results from two studies (33 from this study and additional 24 individuals from study NCT02234427; 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.

Comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after 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

Measure	Aspirin n=57 Participants Participants treated with aspirin - there is no control group. Participant's baseline will act as their control. Aspirin: 81 mg daily for 4 weeks
Changes in Platelet Transcriptome	77.1 FPKM difference 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: rqayyum@jhmi.edu

Results disclosure agreements

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