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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients who have had a heart attack.
Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack.
Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.
Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 81 mg Aspirin |
|
| 2 | Active Comparator | 162 mg Aspirin |
|
| 3 | Active Comparator | 325 mg Aspirin |
|
| 4 | Active Comparator | 650 mg Aspirin |
|
| 5 | Active Comparator | 1300 mg Aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nitric Oxide Formation From Baseline to 3 Months. | Heme oxygenase a downstream target of nitric oxide formation | Baseline to 3 Months (90-97 days) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory Markers From Baseline to 3 Months. | Baseline to 3 Months (90-97 days) | |
| Change in Platelet Biomarkers From Baseline to 3 Months. | Baseline to 3 Months (90-97 days) |
Inclusion Criteria:
Age 40 to 80 years, inclusive.
Patients with stable coronary disease, with and without diabetes mellitus, defined by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles H Hennekens, MD, DrPH | Florida Atlantic University | Principal Investigator |
| Wendy R Schneider, MSN, CCRC | Florida Atlantic University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cardiovascular Research | Atlantis | Florida | 33462 | United States | ||
| The Broward Heart Group, P.A. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14680440 | Background | Williams A, Hennekens CH. The role of aspirin in cardiovascular diseases--forgotten benefits? Expert Opin Pharmacother. 2004 Jan;5(1):109-15. doi: 10.1517/14656566.5.1.109. | |
| 2676237 | Background | Hennekens CH, Buring JE, Sandercock P, Collins R, Peto R. Aspirin and other antiplatelet agents in the secondary and primary prevention of cardiovascular disease. Circulation. 1989 Oct;80(4):749-56. doi: 10.1161/01.cir.80.4.749. No abstract available. |
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This trial did not include a wash-out or run-in period.
37 subjects were enrolled. Recruitment began in November 2006 and completed in July 2007 in two cardiology office practices directed by Ricky Schneider M.D. and Steven Borzak M.D.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 of 5 Randomized Treatment Arms | 81 mg Aspirin |
| FG001 | 2 of 5 Randomized Treatment Arms | 162 mg Aspirin |
| FG002 | 3 of 5 Randomized Treatment Arms | 325 mg Aspirin |
| FG003 | 4 of 5 Randomized Treatment Arms | 650 mg Aspirin |
| FG004 | 5 of 5 Randomized Treatment Arms | 1300 mg Aspirin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 of 5 Randomized Treatment Arms | 81 mg Aspirin |
| BG001 | 2 of 5 Randomized Treatment Arms | 162 mg Aspirin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Nitric Oxide Formation From Baseline to 3 Months. | Heme oxygenase a downstream target of nitric oxide formation | Complete baseline and follow-up data | Posted | Mean | Standard Deviation | ng/mL | Baseline to 3 Months (90-97 days) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 of 5 Randomized Treatment Arms | 81 mg Aspirin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nose Bleed | General disorders |
At the conclusion of the trial in 2010, due to lack of funds for analysis, we chose to analyze and report only the change in nitric oxide formation from baseline to 3 months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles H. Hennekens, M.D. | Florida Atlantic University | chenneke@fau.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Tamarac |
| Florida |
| 33321 |
| United States |
| 5284360 | Background | Vane JR. Inhibition of prostaglandin synthesis as a mechanism of action for aspirin-like drugs. Nat New Biol. 1971 Jun 23;231(25):232-5. doi: 10.1038/newbio231232a0. No abstract available. |
| 810797 | Background | Roth GJ, Stanford N, Majerus PW. Acetylation of prostaglandin synthase by aspirin. Proc Natl Acad Sci U S A. 1975 Aug;72(8):3073-6. doi: 10.1073/pnas.72.8.3073. |
| 7045161 | Background | Patrignani P, Filabozzi P, Patrono C. Selective cumulative inhibition of platelet thromboxane production by low-dose aspirin in healthy subjects. J Clin Invest. 1982 Jun;69(6):1366-72. doi: 10.1172/jci110576. |
| 3790723 | Background | Reilly IA, FitzGerald GA. Inhibition of thromboxane formation in vivo and ex vivo: implications for therapy with platelet inhibitory drugs. Blood. 1987 Jan;69(1):180-6. |
| 1154306 | Background | Mustard JF, Packham MA. The role of blood and platelets in atherosclerosis and the complications of atherosclerosis. Thromb Diath Haemorrh. 1975 Jun 30;33(3):444-56. |
| 928433 | Background | Mustard JF, Moore S, Packham MA, Kinlough-Rathbone RL. Platelets, thrombosis and atherosclerosis. Prog Biochem Pharmacol. 1977;13:312-25. |
| 356564 | Background | Mustard JF, Packham MA, Kinlough-Rathbone RL. Platelets and thrombosis in the development of atherosclerosis and its complications. Adv Exp Med Biol. 1978;102:7-30. doi: 10.1007/978-1-4757-1217-9_2. No abstract available. |
| 10458713 | Background | Ikonomidis I, Andreotti F, Economou E, Stefanadis C, Toutouzas P, Nihoyannopoulos P. Increased proinflammatory cytokines in patients with chronic stable angina and their reduction by aspirin. Circulation. 1999 Aug 24;100(8):793-8. doi: 10.1161/01.cir.100.8.793. |
| 9077376 | Background | Ridker PM, Cushman M, Stampfer MJ, Tracy RP, Hennekens CH. Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men. N Engl J Med. 1997 Apr 3;336(14):973-9. doi: 10.1056/NEJM199704033361401. |
| 15381661 | Background | Hennekens CH, Schror K, Weisman S, FitzGerald GA. Terms and conditions: semantic complexity and aspirin resistance. Circulation. 2004 Sep 21;110(12):1706-8. doi: 10.1161/01.CIR.0000142056.69970.DB. No abstract available. |
| 9155612 | Background | Steer KA, Wallace TM, Bolton CH, Hartog M. Aspirin protects low density lipoprotein from oxidative modification. Heart. 1997 Apr;77(4):333-7. doi: 10.1136/hrt.77.4.333. |
| 11804997 | Background | Wu R, Lamontagne D, de Champlain J. Antioxidative properties of acetylsalicylic Acid on vascular tissues from normotensive and spontaneously hypertensive rats. Circulation. 2002 Jan 22;105(3):387-92. doi: 10.1161/hc0302.102609. |
| 9598599 | Background | Oberle S, Polte T, Abate A, Podhaisky HP, Schroder H. Aspirin increases ferritin synthesis in endothelial cells: a novel antioxidant pathway. Circ Res. 1998 May 18;82(9):1016-20. doi: 10.1161/01.res.82.9.1016. |
| 12927812 | Background | Grosser N, Abate A, Oberle S, Vreman HJ, Dennery PA, Becker JC, Pohle T, Seidman DS, Schroder H. Heme oxygenase-1 induction may explain the antioxidant profile of aspirin. Biochem Biophys Res Commun. 2003 Sep 5;308(4):956-60. doi: 10.1016/s0006-291x(03)01504-3. |
| 9355934 | Background | Hennekens CH, Dyken ML, Fuster V. Aspirin as a therapeutic agent in cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation. 1997 Oct 21;96(8):2751-3. doi: 10.1161/01.cir.96.8.2751. No abstract available. |
| 16391594 | Background | Hennekens CH, Hollar D, Baigent C. Sex-related differences in response to aspirin in cardiovascular disease: an untested hypothesis. Nat Clin Pract Cardiovasc Med. 2006 Jan;3(1):4-5. doi: 10.1038/ncpcardio0420. No abstract available. |
| 23524841 | Derived | Hetzel S, DeMets D, Schneider R, Borzak S, Schneider W, Serebruany V, Schroder H, Hennekens CH. Aspirin increases nitric oxide formation in chronic stable coronary disease. J Cardiovasc Pharmacol Ther. 2013 May;18(3):217-21. doi: 10.1177/1074248413482753. Epub 2013 Mar 21. |
| BG002 |
| 3 of 5 Randomized Treatment Arms |
325 mg Aspirin |
| BG003 | 4 of 5 Randomized Treatment Arms | 650 mg Aspirin |
| BG004 | 5 of 5 Randomized Treatment Arms | 1300 mg Aspirin |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
325 mg Aspirin
| OG003 | 4 of 5 Randomized Treatment Arms | 650 mg Aspirin |
| OG004 | 5 of 5 Randomized Treatment Arms | 1300 mg Aspirin |
|
|
| Other Pre-specified | Change in Inflammatory Markers From Baseline to 3 Months. | At the conclusion of the trial in 2010, due to lack of funds for analysis, analysis was not conducted. | Posted | Baseline to 3 Months (90-97 days) |
|
|
| Other Pre-specified | Change in Platelet Biomarkers From Baseline to 3 Months. | At the conclusion of the trial in 2010, due to lack of funds for analysis, analysis was not conducted. | Posted | Baseline to 3 Months (90-97 days) |
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | 2 of 5 Randomized Treatment Arms | 162 mg Aspirin | 0 | 7 | 0 | 7 |
| EG002 | 3 of 5 Randomized Treatment Arms | 325 mg Aspirin | 0 | 7 | 2 | 7 |
| EG003 | 4 of 5 Randomized Treatment Arms | 650 mg Aspirin | 0 | 7 | 1 | 7 |
| EG004 | 5 of 5 Randomized Treatment Arms | 1300 mg Aspirin | 0 | 8 | 0 | 8 |
| Bleeding Gums | General disorders |
|
| Rectal Bleeding | General disorders |
|
| Prepyloric ulcer | General disorders |
|
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| D006331 |
| Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |