Status:
COMPLETED
Mechanism Based Resistance to Aspirin
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institutes of Health (NIH)
Bayer
Conditions:
Aspirin Resistance
Pharmacological Aspirin Non-responsiveness
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this research is to study why some people do not respond to the benefits of aspirin therapy. The benefit of aspirin is cardioprotection, or decreasing the risk of heart attack and/or st...
Eligibility Criteria
Inclusion
- Age between 18 - 55
- Subjects must be in good health as based on medical history, physical examination, vital signs, and laboratory tests.
- All subjects must be non- smoking volunteers
- Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, depo-provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and just prior to the start of each treatment phase of the study, which must be negative at all time points.
- Subjects must be within 30% of their ideal body weight.
Exclusion
- Female subjects who are pregnant or nursing a child.
- Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
- Subjects with any coagulation, bleeding or blood disorders.
- Subjects who are sensitive or allergic to aspirin as well as any of their components.
- Subjects with documented history of any gastrointestinal disorders, including bleeding ulcers.
- Subjects with any evidence of cancer.
- Subjects with a history of heart disease, including myocardial infarction, angina, coronary artery disease, any evidence of coronary artery stenosis, arrhythmias, heart failure, having had a CABG
- Subjects with renal, hepatic, respiratory, endocrine, metabolic, hematopoietic or neurological disorder.
- Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
- Subjects who have had a history of drug or alcohol abuse within the last 6 months.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00948987
Start Date
September 1 2004
End Date
October 1 2009
Last Update
October 15 2009
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