Paracetamol and Endothelial Function in Patients With Stable Coronary Artery 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
- Primary Efficacy endpoint: To investigate the effect of paracetamol on endothelial function as compared to placebo in patients with stable coronary artery disease.
研究概览
简要总结
The purpose of this study is to determine the effect of orally given paracetamol on the vascular function and on 24-hour blood pressure in patients with coronary artery disease
详细描述
Patients with chronic pain diseases (e.g. osteoarthritis) are dependent on effective medication. NSAIDs are very effective in lowering pain in these patients. Recently there has aroused major concern with regard to cardiovascular side effects and safety, especially in selective cyclooxygenase-2 inhibitors (coxibs) but also in "regular" NSAIDs.
At the moment, there is a big confusion, whether these drugs still should be used, especially in patients with known coronary artery disease. Physicians now try to switch to high dose paracetamol, despite the weaker efficacy in pain relieve, because this drug is considered generally as not harmful.
As there is very few information on the cardiovascular effect of this drug, we plan to perform this study and investigate the impact of paracetamol on endothelial function, an important cardiovascular surrogate marker, on inflammatory markers and on oxidative stress in patients with coronary artery disease on top of standard medication, including aspirin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 30 - 80 years
- •History of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test)
- •Stable cardiovascular medication for at least 1 month
- •Written obtained informed consent
排除标准
- •myocardial infarction, unstable angina, stroke within 3 months prior to study entry
- •coronary intervention/revascularisation procedure within 3 months prior to study entry
- •Left ventricular ejection fraction <50%
- •Other analgesics (Platelet inhibition therapy with Aspirin 100mg/d will be continued)
- •Long acting nitrates
- •Chronic heart failure (> NYHA II)
- •Ventricular tachyarrhythmias
- •Renal failure (serum creatinine >200umol)
- •Liver disease (ALT or AST >100 IU), especially acute hepatitis
- •Hyperbilirubinemia
- •Alcohol abuse
- •Oral Anticoagulation
- •Concomitant therapy with Phenobarbital, Phenytoin, Carbamazepin, Isonicotinic Acid, Chloramphenicol Chlorzoxazone, Zidovudine, Salicylamide
- •Insulin-dependent diabetes mellitus
- •Drug abuse
- •Anemia (Hb<10 g/dl)
- •Known allergies on Paracetamol
- •Pregnancy
- •Malignancy (unless healed or remission > 5 years)
- •Symptomatic hypotension, hypertension >160/100 mmHg
- •Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
- •Participation in another study within the last month
结局指标
主要结局
Primary Efficacy endpoint: To investigate the effect of paracetamol on endothelial function as compared to placebo in patients with stable coronary artery disease.
时间窗: 2 weeks
primary safety endpoint: to evaluate the effect of paracetamol on 24-hour systolic and diastolic blood pressure as compared to placebo in patients with stable coronary artery disease.
时间窗: 2 Weeks
次要结局
- To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function(two weeks)