Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome (PAD)

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ClinicalTrials.gov Identifier: NCT00272311

Recruitment Status : Completed

First Posted : January 5, 2006

Results First Posted : June 19, 2012

Last Update Posted : February 27, 2019

Sponsor:

Collaborator:

Bayer

Information provided by (Responsible Party):

Florida Atlantic University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases Metabolic Syndrome X Atherosclerosis	Drug: Aspirin	Phase 4

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	A Randomized, Double-Blind Trial to Test Higher- Versus Lower-Doses of Aspirin on Inflammatory Markers and Platelet Biomarkers and Nitric Oxide Formation in High Risk Primary Prevention (Patients With Metabolic Syndrome)
Study Start Date :	October 2006
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis Metabolic Syndrome

Drug Information available for: Aspirin

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 81 mg Aspirin	Drug: Aspirin Dosage
Active Comparator: 2 162 mg Aspirin	Drug: Aspirin Dosage
Active Comparator: 3 325 mg Aspirin	Drug: Aspirin Dosage
Active Comparator: 4 650 mg Aspirin	Drug: Aspirin Dosage
Active Comparator: 5 1300 mg Aspirin	Drug: Aspirin Dosage

Outcome Measures

Primary Outcome Measures :

Change in Nitric Oxide Formation From Baseline to 3 Months [ Time Frame: Baseline to 3 Months (90-97 days) ]
Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.

Other Outcome Measures:

Change in Inflammatory Markers From Baseline to 3 Months. [ Time Frame: Baseline to 3 Months (90-97 days) ]
Change in Platelet Biomarkers From Baseline to 3 Months. [ Time Frame: Baseline to 3 Months (90-97 days) ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Exclusion Criteria:

Patients taking greater than 81mg aspirin daily.
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.
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.
Patients who are currently cigarette smokers.
Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.
Patients with any coagulation, bleeding or blood disorders.
Patients who are sensitive or allergic to aspirin.
Patients with documented history of any gastrointestinal disorders, including bleeding ulcers.
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.
Patients with asthma, rhinitis, or nasal polyps.
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.
Patients with Class IV heart failure.
Patients with severe aortic insufficiency, or aortic regurgitation.
Patients with hearing loss or tinnitus.
Patients with tremors which cause them not to be able to remain motionless for approximately 30 seconds.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272311

Locations

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United States, Maryland
HeartDrug Research, LLC
Towson, Maryland, United States, 21204

Sponsors and Collaborators

Florida Atlantic University

Bayer

Investigators

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Principal Investigator:	Charles H Hennekens, MD, DrPH	Florida Atlantic University
Study Director:	Wendy R Schneider, MSN, CCRC	Florida Atlantic University

More Information

Publications:

Williams A, Hennekens CH. The role of aspirin in cardiovascular diseases--forgotten benefits? Expert Opin Pharmacother. 2004 Jan;5(1):109-15. Review.

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. Review.

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.

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.

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.

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.

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.

Mustard JF, Moore S, Packham MA, Kinlough-Rathbone RL. Platelets, thrombosis and atherosclerosis. Prog Biochem Pharmacol. 1977;13:312-25.

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. Review.

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.

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. Erratum in: N Engl J Med 1997 Jul 31;337(5):356.

Hennekens CH, Schror K, Weisman S, FitzGerald GA. Terms and conditions: semantic complexity and aspirin resistance. Circulation. 2004 Sep 21;110(12):1706-8. Review.

Steer KA, Wallace TM, Bolton CH, Hartog M. Aspirin protects low density lipoprotein from oxidative modification. Heart. 1997 Apr;77(4):333-7.

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.

Oberle S, Polte T, Abate A, Podhaisky HP, Schröder H. Aspirin increases ferritin synthesis in endothelial cells: a novel antioxidant pathway. Circ Res. 1998 May 18;82(9):1016-20.

Grosser N, Abate A, Oberle S, Vreman HJ, Dennery PA, Becker JC, Pohle T, Seidman DS, Schröder H. Heme oxygenase-1 induction may explain the antioxidant profile of aspirin. Biochem Biophys Res Commun. 2003 Sep 5;308(4):956-60.

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.

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.

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.

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. Review.

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Responsible Party:	Florida Atlantic University
ClinicalTrials.gov Identifier:	NCT00272311
Other Study ID Numbers:	H08-35
First Posted:	January 5, 2006 Key Record Dates
Results First Posted:	June 19, 2012
Last Update Posted:	February 27, 2019
Last Verified:	February 2019

Keywords provided by Florida Atlantic University:


Primary prevention Cardiovascular diseases Aspirin Metabolic Syndrome X Atherosclerosis

Additional relevant MeSH terms:

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Cardiovascular Diseases Atherosclerosis Microvascular Angina Metabolic Syndrome Syndrome Disease Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Angina Pectoris	Myocardial Ischemia Heart Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors

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