Myocardial Infarction Clinical Trial
Official title:
A Randomized, Double-Blind, Crossover Study to Evaluate the Mechanism of Action of Acetaminophen
NCT number | NCT00646906 |
Other study ID # | 708270 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2, 2004 |
Est. completion date | January 24, 2012 |
Verified date | November 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study investigates whether the ability of aspirin to reduce the risk of heart
attacks may be diminished by the administration of acetaminophen. Patients who have heart
disease are often prescribed aspirin because of its unique ability to permanently prevent
platelets from aggregating and forming a blood clot. Such blood clots cause heart attacks
when they form in a blood vessel that supplies the heart with oxygen rich blood. Some of
these same patients also take acetaminophen everyday for relief from arthritis pain. Higher
doses of acetaminophen may also have the ability to prevent the platelets from clotting,
however only temporarily. Therefore, this study evaluates whether the timing of the
administration of acetaminophen (before or after aspirin) interferes with the permanent blood
clotting effects of aspirin.
The primary hypothesis is that acetaminophen given two hours before aspirin will antagonize
the effects of aspirin, while reversing the order of administration will not.
Status | Completed |
Enrollment | 55 |
Est. completion date | January 24, 2012 |
Est. primary completion date | January 24, 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Age between 18 - 55 - Subjects recruited for the "non-smoker group" must be in good health as based on medical history, physical examination, vital signs, and laboratory tests. - Subjects recruited for the "smokers group" will be chronic smokers of at least 4 years duration, but no longer than 20 years duration, who smoke 11-20 cigarettes per day. Smokers must be otherwise healthy as described above. - Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, depo-provera injection, intrauterine device, 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 acetaminophen and/or 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 coronary intervention or significant irregularities in the EKG. - Subjects with history of peripheral artery disease (claudication, bypass surgery or stent placement in extremity.) - Subjects with a history of stroke or transitory ischemic attacks. - Subjects with renal, hepatic, respiratory, endocrine, metabolic, hematopoietic or neurological disorder. - Subjects with a history of liver disease or abnormal liver function tests (>2x upper limit normal). - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of The University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change in Serum Thromboxane B2 | Thromboxan B2 is a stable metabolite of thromboxane A2. Thromboxane B2 formation during clotting of whole blood (37 degrees Celsius, 1 hour) is reflective of the capacity of platelets to form thromboxane A2. Serum Thromboxane B2 was measured by radio-immuno assay. The quantity of interest was percent change from start (8:00 am on day 1) to finish (8:00 am on last day) of each crossover period in serum thromboxane B2. This was calculated as: 100%*(value at start of period minus value at end of period)/value at start of period. | 7 days (Phase 1a and 1b), 4 days (Phase 2) | |
Secondary | Percent Change in Arachidonic Acid Induced Platelet Aggregation | Platelet aggregation was induced by 500 micro molar arachidonic acid using a Chronolog aggregometer. The quantity of interest was percent change from start (8:00 am on day 1) to finish (8:00 am on last day) of each crossover period in platelet aggregation. This was calculated as: 100%*(value at start of period minus value at end of period)/value at start of period. | 7 days (only Phase 1a) |
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