A Randomized, Double-Blind Trial to Test Higher- Versus Lower-Doses of Aspirin on Inflammatory Markers and Platelet Biomarkers and Nitric Oxide Formation & Endothelial Function in Secondary Prevention (Pts w/Chronic Stable Coronary Disease)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in Nitric Oxide Formation From Baseline to 3 Months.
研究概览
简要总结
The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients who have had a heart attack.
详细描述
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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40 to 80 years, inclusive.
- •Patients with stable coronary disease, with and without diabetes mellitus, defined by:
- •angiographic evidence of 70% or greater stenosis, or
- •previous percutaneous coronary intervention (PCI), or
- •coronary artery bypass graft (CABG), or
- •history of a MI, or
- •positive exercise test
排除标准
- •Patients taking greater than 81mg aspirin daily.
- •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 within 6 months of a coronary intervention, including PCI or CABG.
- •Patients with a planned coronary intervention.
- •Patients taking anti-platelet drugs such as clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin.
- •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 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 trial 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.
研究组 & 干预措施
1
81 mg Aspirin
干预措施: Aspirin (Drug)
2
162 mg Aspirin
干预措施: Aspirin (Drug)
3
325 mg Aspirin
干预措施: Aspirin (Drug)
4
650 mg Aspirin
干预措施: Aspirin (Drug)
5
1300 mg Aspirin
干预措施: Aspirin (Drug)
结局指标
主要结局
Change in Nitric Oxide Formation From Baseline to 3 Months.
时间窗: Baseline to 3 Months (90-97 days)
Heme oxygenase a downstream target of nitric oxide formation
次要结局
未报告次要终点