Mechanism Based Resistance to Aspirin
This study has been completed.
Sponsor:
University of Pennsylvania
Collaborators:
Bayer
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948987
First received: July 29, 2009
Last updated: October 14, 2009
Last verified: October 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Aspirin Resistance Pharmacological Aspirin Non-responsiveness |
Drug: Aspirin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mechanism Based Resistance to Aspirin |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- Arachidonic acid induced platelet aggregation [ Time Frame: 8 hours postdose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Serum thromboxane B2 concentration Urinary 11-dehydro thromboxane B2 concentration Urinary 2,3 dinor-6 keto PGF1α concentration [ Time Frame: 8 hours postdose ] [ Designated as safety issue: No ]
| Enrollment: | 400 |
| Study Start Date: | September 2004 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aspirin
single dose of aspirin 325 mg p.o.
|
Drug: Aspirin
325 mg enteric coated single dose p.o.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948987
Sponsors and Collaborators
University of Pennsylvania
Bayer
Investigators
| Principal Investigator: | Garret A FitzGerald, MD | University of Pennsylvania, Institute for Translationals Medicine and Therapeutics |
| Principal Investigator: | Susanne Fries, MD | University of Pennsylvania, Institute for Translationals Medicine and Therapeutics |
| Principal Investigator: | Tilo Grosser, MD | University of Pennsylvania, Institute for Translationals Medicine and Therapeutics |
More Information
No publications provided by University of Pennsylvania
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Garret A. FitzGerald, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00948987 History of Changes |
| Other Study ID Numbers: | 801907, 0926 |
| Study First Received: | July 29, 2009 |
| Last Updated: | October 14, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pennsylvania:
|
aspirin resistance cardiovascular risk prostaglandins platelet inhibition |
Additional relevant MeSH terms:
|
Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013