Mechanism Based Resistance to Aspirin
Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aspirin Resistance; Pharmacological Aspirin Non-responsiveness
Intervention: Aspirin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s): Garret A FitzGerald, MD, Principal Investigator, Affiliation: University of Pennsylvania, Institute for Translationals Medicine and Therapeutics Susanne Fries, MD, Principal Investigator, Affiliation: University of Pennsylvania, Institute for Translationals Medicine and Therapeutics Tilo Grosser, MD, Principal Investigator, Affiliation: University of Pennsylvania, Institute for Translationals Medicine and Therapeutics
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 stroke. Aspirin works by disabling the platelets, part of the blood cells used
in clotting, from sticking together and forming blood clots, thus protecting the heart. It
has been observed that failure to respond to aspirin therapy occurs in about 10% of the
general population and that despite taking aspirin everyday, this group of non- responders
is not getting protection for their heart. The investigators would like to determine why and
how this happens.
Clinical Details
Official title: Mechanism Based Resistance to Aspirin
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Arachidonic acid induced platelet aggregation
Secondary outcome: Serum thromboxane B2 concentration Urinary 11-dehydro thromboxane B2 concentration Urinary 2,3 dinor-6 keto PGF1α concentration
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: September 2004
Last updated: October 14, 2009
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