Atherosclerosis, Cardiovascular Diseases, Metabolic Syndrome X
Conditions
Keywords
Primary prevention, Cardiovascular diseases, Aspirin, Metabolic Syndrome X, Atherosclerosis
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.
Interventions
DRUGAspirin
Dosage
Sponsors
Bayer
Florida Atlantic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nitric Oxide Formation From Baseline to 3 Months | Baseline to 3 Months (90-97 days) | Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation. |
Other
| Measure | Time frame |
|---|---|
| Change in Inflammatory Markers From Baseline to 3 Months. | Baseline to 3 Months (90-97 days) |
| Change in Platelet Biomarkers From Baseline to 3 Months. | Baseline to 3 Months (90-97 days) |
Countries
United States
Participant flow
Recruitment details
From Dec 2006 through May 2007, 70 eligible subjects were randomized from a primary care clinical site under the direction of Alex Pokov, MD.
Pre-assignment details
In this trial there was no wash-out or run-in period, as all eligible subjects were not taking aspirin.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 of 5 Randomized Treatment Arms 81 mg Aspirin | 14 |
| Arm 2 of 5 Randomized Treatment Arms 162 mg Aspirin | 14 |
| Arm 3 of 5 Randomized Treatment Arms 325 mg Aspirin | 14 |
| Arm 4 of 5 Randomized Treatment Arms 650 mg Aspirin | 14 |
| Arm 5 of 5 Randomized Treatment Arms 1300 mg Aspirin | 14 |
| Total | 70 |
Baseline characteristics
| Characteristic | Arm 2 of 5 Randomized Treatment Arms | Arm 3 of 5 Randomized Treatment Arms | Arm 4 of 5 Randomized Treatment Arms | Arm 1 of 5 Randomized Treatment Arms | Arm 5 of 5 Randomized Treatment Arms | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 11 Participants | 11 Participants | 8 Participants | 51 Participants |
| Age, Continuous | 57.0 years STANDARD_DEVIATION 10 | 55.5 years STANDARD_DEVIATION 9.2 | 58.0 years STANDARD_DEVIATION 9.6 | 58.3 years STANDARD_DEVIATION 10.3 | 59.1 years STANDARD_DEVIATION 11.4 | 57.6 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment United States | 14 participants | 14 participants | 14 participants | 14 participants | 14 participants | 70 participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 5 Participants | 4 Participants | 9 Participants | 33 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 9 Participants | 10 Participants | 5 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 |
Outcome results
Primary
Change in Nitric Oxide Formation From Baseline to 3 Months
Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.
Time frame: Baseline to 3 Months (90-97 days)
Population: Complete baseline and follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 of 5 Randomized Treatment Arms | Change in Nitric Oxide Formation From Baseline to 3 Months | 27.6 ng/mL | Standard Deviation 4.9 |
| Arm 2 of 5 Randomized Treatment Arms | Change in Nitric Oxide Formation From Baseline to 3 Months | 27.0 ng/mL | Standard Deviation 4.4 |
| Arm 3 of 5 Randomized Treatment Arms | Change in Nitric Oxide Formation From Baseline to 3 Months | 31.4 ng/mL | Standard Deviation 9.8 |
| Arm 4 of 5 Randomized Treatment Arms | Change in Nitric Oxide Formation From Baseline to 3 Months | 25.7 ng/mL | Standard Deviation 3.4 |
| Arm 5 of 5 Randomized Treatment Arms | Change in Nitric Oxide Formation From Baseline to 3 Months | 28.3 ng/mL | Standard Deviation 4.1 |
Other Pre-specified
Change in Inflammatory Markers From Baseline to 3 Months.
Time frame: Baseline to 3 Months (90-97 days)
Population: At the end of the study, due to lack of funds, analysis of this outcome was not conducted.
Other Pre-specified
Change in Platelet Biomarkers From Baseline to 3 Months.
Time frame: Baseline to 3 Months (90-97 days)
Population: At the end of the study due to lack of funds analysis of this data was not conducted.