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COMPLETEDPHASE4

Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome

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)

NCT00272311•Florida Atlantic University

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Yes

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

•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.
+5 more criteria

Locations (1)

HeartDrug Research, LLC

Towson, Maryland, United States

Key Dates

Start Date

October 1, 2006

Primary Completion Date

January 1, 2009

Completion Date

January 1, 2009

Last Updated

February 27, 2019

Enrollment

ACTUAL participants

Conditions

Cardiovascular DiseasesMetabolic Syndrome XAtherosclerosis

Interventions

Aspirin

DRUG

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

View study

RECRUITINGPHASE3

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

The Prevalence, Disease Burden and Prognosis of COPD in Patients With Cardiovascular Diseases

OPTImizing CArdiac REhabilitation by REfining Sleep and STress

A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic Stenosis

CLEANer Aspiration for Pulmonary Embolism