CAD
Conditions
Keywords
aspirin resistance, hyporesponsive, CAD, women
Brief summary
The purpose of this study is to measure the percentage of women with known Coronary Artery Disease (CAD) who are hyporesponsive to low dose (81 mg) aspirin.
Interventions
None listed
Sponsors
Creighton University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Able and willing to provide informed consent * Women at least 45 years old of any race * Taking 81 mg aspirin daily, for at least one month * Diagnosed with known or suspected CAD with at least one of the following: angiographic evidence of at least one lesion \> 50% stenosis, history of significant elevation of biomarker troponin or CK-MB, or history of ECG changes in at least 2 contiguous leads characterized by either new ST depression \> 0.1 mV or transient (\<30 min) ST elevation \> 0.1 mV, coronary artery revascularization either by PCI or CABG
Exclusion criteria
* \< 45 years or \> 85 years of age * Clinically unstable: hypotension defined as sustained systolic blood pressure of \<90 mmHg due to cardiac failure with associated symptoms, unstable or severe pulmonary edema, decompensated congestive heart failure, acute mitral regurgitation, acute ventricular septal defect, acute cerebrovascular event or transient ischemic attack (TIA) within the past six months, history of ventricular fibrillation and no implantable cardioverter defibrillator (ICD), sustained supraventricular tachycardia \> 30 seconds or associated with symptoms and no ICD, untreated complete heart block or untreated high grade secondary heart block * Pregnant, planning to become pregnant, or breastfeeding * Alcohol abuse or illicit drug abuse * Allergy or intolerance to salicylates and/or excipients including a history of and/or active GI bleed * Use of NSAIDs within seven days or planned regular use during the study * Taking HRT or oral contraceptives within the past 30 days or planned use during study * Use of heparin, warfarin, ADP inhibitors (clopidogrel, prasugrel, or ticlopidine), or glycoprotein IIb/IIa inhibitors within previous 96 hours or planned use during the study * Use or planned use of any other medications known to interfere with AA-induced platelet function * Currently participating in another investigational drug or device study * Survival less than six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin | Time of enrollment | Hyporesponsive was defined as Aspirin Response Unit (ARU) \> 550 equating to less than 50% platelet inhibition. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aspirin 81 mg Women with CAD taking 81 mg aspirin. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Aspirin 81 mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age Continuous | 71.8 years STANDARD_DEVIATION 6.13 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 15 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 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin
Hyporesponsive was defined as Aspirin Response Unit (ARU) \> 550 equating to less than 50% platelet inhibition.
Time frame: Time of enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspirin 81 mg | Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin | 0 participants |