Heart Disease
Conditions
Brief summary
The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then re-tested for aspirin responsiveness.
Interventions
DRUGAspirin
Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily
Sponsors
Creighton University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women at least 19 years old * Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease. * Able and willing to provide informed consent
Exclusion criteria
* Pregnancy or breastfeeding * Known CHD * Currently taking clopidogrel or ticlopidine * Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours * Allergy or hypersensitivity to salicylates * Use of other OTC or prescription analgesics or anti-inflammatory medication in the past two weeks * Currently participating in another investigational drug or device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Aspirin Resistant | Baseline | Aspirin responsive unit (ARU) \> 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg | 2 weeks | Aspirin resistance was defined as ARU \> 550 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aspirin 81mg Aspirin 81mg at baseline | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Aspirin 81mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age Continuous Non-resistant to 81 mg | 52.6 years STANDARD_DEVIATION 8.3 |
| Age Continuous Resistant to 81 mg | 56.7 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Number of Women Aspirin Resistant
Aspirin responsive unit (ARU) \> 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspirin 81 mg | Number of Women Aspirin Resistant | 3 participants |
Secondary
Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg
Aspirin resistance was defined as ARU \> 550
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspirin 81 mg | Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg | 3 participants |