Atherosclerosis
Conditions
Keywords
aspirin, atherosclerosis
Brief summary
This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene expression in persons at high-risk of developing heart attacks due to family history of early-onset coronary artery disease
Detailed description
In this clinical trials we will select individuals from GeneSTAR cohort based o their platelet function. Equal number of individuals will be selected from each race and gender and from low or high platelet aggregation. We will have baseline platelet functions performed and baseline platelet gene expression examined. Participants will be given 2-week supply of aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation studies and a repeat platelet gene-expression (using RNA-seq). The ultimate goal is to examine platelet gene expression differences due to aspirin and across different gender, race, platelet-aggregation groups.
Interventions
DRUGAspirin
2-week aspirin therapy (81mg/day)
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 45-75 years * GeneSTAR participant * No personal History of Coronary Artery Disease * Women who are post-menopausal * Women who are using a reliable method of contraception, such as history of tubal ligation, IUD or taking OCP
Exclusion criteria
* Taking aspirin prescribed by physician * weight \< 60 kg * History of recent or current bleeding * allergy to aspirin or history of adverse events to aspirin * serious comorbid conditions (such as AIDS, active cancer) * high blood pressure (\>160/95) * History of gastrointestinal ulcer/bleeding * Mental incompetence to make decision to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differential Gene Expression | 2-weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aspirin Aspirin: 2-week aspirin therapy (81mg/day) | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Aspirin |
|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 10.3 |
| Gender Female | 17 Participants |
| Gender Male | 17 Participants |
| Race/Ethnicity, Customized African Americans | 17 participants |
| Race/Ethnicity, Customized Caucasians | 17 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Differential Gene Expression
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aspirin | Differential Gene Expression | 77.1 FPKM for HBG1 Gene | Standard Error 19.8 |
Comparison: Null Hypothesis: There is no difference in gene expression before and after aspirin therapyp-value: <0.000005negative binomial