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Completed

NCT Number: NCT00272311

Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome

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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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HeartDrug Research, LLC

Towson, Maryland, 21204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age 40 to 80 years, inclusive.
  • No previous heart attack or a stroke, or other forms of these diseases.
  • Have at least three of the five characteristics listed below, indicating presence of metabolic syndrome, as defined by NCEP-III:
  • waist measuring more than 40 inches (for men) or more than 35 inches (for women),
  • high density lipoprotein (HDL) cholesterol levels lower than 40 milligrams per deciliter (mg/dl) in men or 50 mg/dl in women,
  • triglyceride (TG) levels above 150 mg/dl,
  • blood pressure greater than 130 millimeters of mercury (mmHg) systolic or 85 mmHg diastolic,
  • 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.

Treatment and study plan

Aspirin

Drug

Dosage

Primary outcomes

  1. 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 outcomes

  1. Change in Inflammatory Markers From Baseline to 3 Months.

    Time frame: Baseline to 3 Months (90-97 days)

  2. Change in Platelet Biomarkers From Baseline to 3 Months.

    Time frame: Baseline to 3 Months (90-97 days)

Sponsors and collaborators

Lead sponsor

Florida Atlantic University

Other

Collaborators

  • Bayer

Registry information

Official study 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)

Acronym: PAD

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 5, 2006
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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