Platelet Dysfunction Due to Aspirin
Conditions
Keywords
genomic markers, aspirin resistance
Brief summary
The study seeks to identify genomic markers associated with aspirin resistance.
Detailed description
Not desired
Interventions
DRUGaspirin
aspirin 81mg, 7-10 days
Sponsors
George Washington University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Volunteers 40 to 80 years old willing to sign consent and take 81 mg of aspirin for 7 - 10 days and return for laboratory testing.
Exclusion criteria
* Patient requiring more than 81 mg aspirin daily * Known GI bleeding attributed to ASA * Active peptic ulcer disease or history within the last year * Known aspirin allergy * Current use of: * warfarin, * heparin, * NSAIDs (except aspirin), * clopidogrel, * dipyridamole, * fish-oil/omega 3 supplements, * Women of childbearing potential who are pregnant, planning to become pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole Blood Coagulation | Single measurement at 7-10 days after beginning aspirin | Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from patients of the GWU Medical Faculty Associates, and physicians, faculty and staff on the GWU campus. Initially we were looking for those already prescribed to take aspirin at 81 mg daily, but due to slow recruitment, this was amended to anyone willing to take aspirin at 81 mg daily for 7-10 days
Pre-assignment details
Excluded were 58 subjects prescribed more than 81 mg of aspirin, had known GI bleeding attributed to aspirin, active peptic ulcer disease, aspirin allergy, current use of other anti-platelet, anti-thrombotic or other therapy that has these properties, women who are pregnant, planning pregnancy or nursing. Exclusions were for safety reasons.
Participants by arm
| Arm | Count |
|---|---|
| Aspirin All subjects took 7-10 days of 81 mg aspirin | 132 |
| Total | 132 |
Baseline characteristics
| Characteristic | Aspirin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 41 Participants |
| Age, Categorical Between 18 and 65 years | 91 Participants |
| Age Continuous | 61 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 132 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 132 |
| serious Total, serious adverse events | 0 / 132 |
Outcome results
Primary
Whole Blood Coagulation
Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.
Time frame: Single measurement at 7-10 days after beginning aspirin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aspirin | Whole Blood Coagulation | 453.8 Aspirin response units (ARU) | Standard Deviation 51.9 |