Clinical trial NCT00272311: Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Metabolic Syndrome X
Atherosclerosis
Keywords: Primary prevention
Cardiovascular diseases
Aspirin
Metabolic Syndrome X
Atherosclerosis
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2006-01-05
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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:

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.

Primary outcomes:
measure: Change in Nitric Oxide Formation From Baseline to 3 Months
timeFrame: Baseline to 3 Months (90-97 days)
Secondary outcomes:
Other outcomes:
measure: Change in Inflammatory Markers From Baseline to 3 Months.
timeFrame: Baseline to 3 Months (90-97 days)
measure: Change in Platelet Biomarkers From Baseline to 3 Months.
timeFrame: Baseline to 3 Months (90-97 days)
Locations:
city: Towson
country: United States
facility: HeartDrug Research, LLC
state: Maryland
Study officials:
affiliation: Florida Atlantic University
name: Charles H Hennekens, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Atlantic University
name: Wendy R Schneider, MSN, CCRC
role: STUDY_DIRECTOR
References:
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