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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 at risk of a first 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. Aspirin also prevents a first 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 | Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) 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:
1. Age 40 to 80 years, inclusive.
2. No previous heart attack or a stroke, or other forms of these diseases.
3. Have at least three of the five characteristics listed below, indicating presence of metabolic syndrome, as defined by NCEP-III:
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 |
|---|---|---|---|---|---|---|
| HeartDrug Research, LLC | Towson | Maryland | 21204 | United States |
| 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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In this trial there was no wash-out or run-in period, as all eligible subjects were not taking aspirin.
From Dec 2006 through May 2007, 70 eligible subjects were randomized from a primary care clinical site under the direction of Alex Pokov, MD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 of 5 Randomized Treatment Arms | 81 mg Aspirin |
| FG001 | Arm 2 of 5 Randomized Treatment Arms | 162 mg Aspirin |
| FG002 | Arm 3 of 5 Randomized Treatment Arms | 325 mg Aspirin |
| FG003 | Arm 4 of 5 Randomized Treatment Arms | 650 mg Aspirin |
| FG004 | Arm 5 of 5 Randomized Treatment Arms | 1300 mg Aspirin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 of 5 Randomized Treatment Arms | 81 mg Aspirin |
| BG001 | Arm 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 | Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) 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 | Arm 1 of 5 Randomized Treatment Arms | 81 mg Aspirin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles H. Hennekens, M.D. | Florida Atlantic University | chenneke@fau.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D024821 | Metabolic Syndrome |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| 14504112 | Background | Eidelman RS, Hebert PR, Weisman SM, Hennekens CH. An update on aspirin in the primary prevention of cardiovascular disease. Arch Intern Med. 2003 Sep 22;163(17):2006-10. doi: 10.1001/archinte.163.17.2006. |
| 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. |
| 11790071 | Background | U.S. Preventive Services Task Force. Aspirin for the primary prevention of cardiovascular events: recommendation and rationale. Ann Intern Med. 2002 Jan 15;136(2):157-60. doi: 10.7326/0003-4819-136-2-200201150-00015. |
| 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. |
| 12119259 | Background | Pearson TA, Blair SN, Daniels SR, Eckel RH, Fair JM, Fortmann SP, Franklin BA, Goldstein LB, Greenland P, Grundy SM, Hong Y, Miller NH, Lauer RM, Ockene IS, Sacco RL, Sallis JF Jr, Smith SC Jr, Stone NJ, Taubert KA. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patients Without Coronary or Other Atherosclerotic Vascular Diseases. American Heart Association Science Advisory and Coordinating Committee. Circulation. 2002 Jul 16;106(3):388-91. doi: 10.1161/01.cir.0000020190.45892.75. No abstract available. |
| BG002 |
| Arm 3 of 5 Randomized Treatment Arms |
325 mg Aspirin |
| BG003 | Arm 4 of 5 Randomized Treatment Arms | 650 mg Aspirin |
| BG004 | Arm 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 | Arm 4 of 5 Randomized Treatment Arms | 650 mg Aspirin |
| OG004 | Arm 5 of 5 Randomized Treatment Arms | 1300 mg Aspirin |
|
|
| Other Pre-specified | Change in Inflammatory Markers From Baseline to 3 Months. | At the end of the study, due to lack of funds, analysis of this outcome 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 end of the study due to lack of funds analysis of this data was not conducted. | Posted | Baseline to 3 Months (90-97 days) |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Arm 2 of 5 Randomized Treatment Arms | 162 mg Aspirin | 0 | 14 | 0 | 14 |
| EG002 | Arm 3 of 5 Randomized Treatment Arms | 325 mg Aspirin | 0 | 14 | 0 | 14 |
| EG003 | Arm 4 of 5 Randomized Treatment Arms | 650 mg Aspirin | 0 | 14 | 0 | 14 |
| EG004 | Arm 5 of 5 Randomized Treatment Arms | 1300 mg Aspirin | 0 | 14 | 0 | 14 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |