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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Florida Atlantic University
ClinicalTrials.gov Identifier:
NCT00272311
First received: January 3, 2006
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Cardiovascular Diseases
Metabolic Syndrome X
Atherosclerosis
Drug: Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:
  • Change in Inflammatory Markers From Baseline to 3 Months [ Time Frame: Baseline to 3 Months (90-97 days) ] [ Designated as safety issue: No ]
  • Change in Platelet Biomarkers From Baseline to 3 Months [ Time Frame: Baseline to 3 Months (90-97 days) ] [ Designated as safety issue: No ]
  • Change in Nitric Oxide Formation From Baseline to 3 Months [ Time Frame: Baseline to 3 Months (90-97 days) ] [ Designated as safety issue: No ]
    Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.


Enrollment: 70
Study Start Date: October 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272311

Locations
United States, Maryland
HeartDrug Research, LLC
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Florida Atlantic University
Bayer
Investigators
Principal Investigator: Charles H Hennekens, MD, DrPH Florida Atlantic University
Study Director: Wendy R Schneider, MSN, CCRC Florida Atlantic University
  More Information

Publications:

Responsible Party: Florida Atlantic University
ClinicalTrials.gov Identifier: NCT00272311     History of Changes
Other Study ID Numbers: H08-35
Study First Received: January 3, 2006
Results First Received: May 16, 2012
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Atlantic University:
Primary prevention
Cardiovascular diseases
Aspirin
Metabolic Syndrome X
Atherosclerosis

Additional relevant MeSH terms:
Metabolic Syndrome X
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on July 31, 2014