Early Phase 1
N=92
Aspirin Resistance in Coronary Artery Disease
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00753935 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Change in Serum Thromboxane B2 — 5.02; 2.78 ng/mL — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- enteric-coated aspirin (Drug); Chewable aspirin (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Thromboxane B2 |
5.02; 2.78 | 0.005 sig |
Summary
The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a molecular level in aspirin-treated patients with coronary artery disease. We hypothesize that certain patient characteristics associate with aspirin resistance. In addition, we will compare the effects of enteric-coated aspirin and chewable aspirin.
Eligibility Criteria
Inclusion Criteria
- On aspirin 81-325mg daily at time of enrollment
- Documented stable coronary artery disease or > 6 months after coronary artery bypass grafting or interventional cardiac procedure
- Written informed consent
Exclusion Criteria
- Pre-menopausal female
- Renal disease (creatinine >= 2 mg/dl)
- Anemia (Hematocrit 180 mmHg)
- Decompensated congestive heart failure
- Recent coronary syndrome (< 6 months)
- History of significant GI bleeding
Data sourced from ClinicalTrials.gov (NCT00753935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.