Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome
NCT ID: NCT00272311
Last Updated: 2019-02-27
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-10-31
Study Completion Date
2009-01-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Cardiovascular Diseases
Metabolic Syndrome X
Atherosclerosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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1
81 mg Aspirin
Group Type
ACTIVE_COMPARATOR
Aspirin
Intervention Type
DRUG
Dosage
2
162 mg Aspirin
Group Type
ACTIVE_COMPARATOR
Aspirin
Intervention Type
DRUG
Dosage
3
325 mg Aspirin
Group Type
ACTIVE_COMPARATOR
Aspirin
Intervention Type
DRUG
Dosage
4
650 mg Aspirin
Group Type
ACTIVE_COMPARATOR
Aspirin
Intervention Type
DRUG
Dosage
5
1300 mg Aspirin
Group Type
ACTIVE_COMPARATOR
Aspirin
Intervention Type
DRUG
Dosage
Interventions
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Aspirin
Dosage
Intervention Type
DRUG
Eligibility Criteria
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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:
1. waist measuring more than 40 inches (for men) or more than 35 inches (for women),
2. high density lipoprotein (HDL) cholesterol levels lower than 40 milligrams per deciliter (mg/dl) in men or 50 mg/dl in women,
3. triglyceride (TG) levels above 150 mg/dl,
4. blood pressure greater than 130 millimeters of mercury (mmHg) systolic or 85 mmHg diastolic,
5. fasting blood sugar greater than 110 mg/dl
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:
1. waist measuring more than 40 inches (for men) or more than 35 inches (for women),
2. high density lipoprotein (HDL) cholesterol levels lower than 40 milligrams per deciliter (mg/dl) in men or 50 mg/dl in women,
3. triglyceride (TG) levels above 150 mg/dl,
4. blood pressure greater than 130 millimeters of mercury (mmHg) systolic or 85 mmHg diastolic,
5. fasting blood sugar greater than 110 mg/dl
Exclusion Criteria
1. Patients taking greater than 81mg aspirin daily.
2. Patients taking anti-platelet drugs such as clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin, during the last two weeks.
3. Patients taking any of the following medications for less than 3 months, or who plan to take them for the first time during the next 3 months: ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers, or statins.
4. Patients who are currently cigarette smokers.
5. Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.
6. Patients with any coagulation, bleeding or blood disorders.
7. Patients who are sensitive or allergic to aspirin.
8. Patients with documented history of any gastrointestinal disorders, including bleeding ulcers.
9. Patients with any evidence of cancer or history of significant cardiovascular disease (including heart attack, stroke or drop attacks termed transient ischemic attacks (TIAs), or blockages of the arteries in the legs termed peripheral arterial disease (PAD)), kidney, liver, lung, blood, or brain disorders.
10. Patients with asthma, rhinitis, or nasal polyps.
11. Patients with any abnormal laboratory value or physical finding that, in the view of the responsible clinician, may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety.
12. Patients with Class IV heart failure.
13. Patients with severe aortic insufficiency, or aortic regurgitation.
14. Patients with hearing loss or tinnitus.
15. Patients with tremors which cause them not to be able to remain motionless for approximately 30 seconds.
2. Patients taking anti-platelet drugs such as clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin, during the last two weeks.
3. Patients taking any of the following medications for less than 3 months, or who plan to take them for the first time during the next 3 months: ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers, or statins.
4. Patients who are currently cigarette smokers.
5. Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.
6. Patients with any coagulation, bleeding or blood disorders.
7. Patients who are sensitive or allergic to aspirin.
8. Patients with documented history of any gastrointestinal disorders, including bleeding ulcers.
9. Patients with any evidence of cancer or history of significant cardiovascular disease (including heart attack, stroke or drop attacks termed transient ischemic attacks (TIAs), or blockages of the arteries in the legs termed peripheral arterial disease (PAD)), kidney, liver, lung, blood, or brain disorders.
10. Patients with asthma, rhinitis, or nasal polyps.
11. Patients with any abnormal laboratory value or physical finding that, in the view of the responsible clinician, may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety.
12. Patients with Class IV heart failure.
13. Patients with severe aortic insufficiency, or aortic regurgitation.
14. Patients with hearing loss or tinnitus.
15. Patients with tremors which cause them not to be able to remain motionless for approximately 30 seconds.
Minimum Eligible Age
40 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Bayer
INDUSTRY
Sponsor Role
collaborator
Florida Atlantic University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Charles H Hennekens, MD, DrPH
Role: PRINCIPAL_INVESTIGATOR
Florida Atlantic University
Wendy R Schneider, MSN, CCRC
Role: STUDY_DIRECTOR
Florida Atlantic University
Locations
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HeartDrug Research, LLC
Towson, Maryland, United States
Site Status
Countries
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United States
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Mustard JF, Moore S, Packham MA, Kinlough-Rathbone RL. Platelets, thrombosis and atherosclerosis. Prog Biochem Pharmacol. 1977;13:312-25.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
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H08-35
Identifier Type: -
Identifier Source: org_study_id
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