ISRCTN34097747已完成不适用
Effect of clopidogrel and acetylsalicylic acid (ASA) versus clopidogrel or ASA alone on brachial flow mediated vasodilation in patients with coronary artery disease: a prospective, double-blind, randomised, single-centre trial
Johannes Gutenberg-University Mainz (Johannes Gutenberg-Universitat Mainz) (Germany)0 个研究点目标入组 120 人开始时间: 2010年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men or women, older than 18 years of age
- •2. Angiographically documented coronary artery disease
- •3. Absence of angina pectoris within the previous four weeks
- •4. Written informed consent must be available before enrolment in the trial
排除标准
- •1. Stroke or peripheral arterial revascularisation within the previous 12 weeks
- •2. Clopidogrel intolerance
- •3. Planned coronary stent implantation within the next 6 weeks
- •4. Haemodynamically significant valvular heart disease
- •5. Known hyper- or hypothyroidism
- •6. Renal dysfunction (creatinine more than 2.0 mg/dl)
- •7. Chronic inflammatory intestinal disease or history of malabsorption
- •8. History of chronic liver disease or pancreatitis
- •9. Existence of acute gastric ulcers or acute gastrointestinal bleeding
- •10. Haemoglobin less than 12 g/dl, white blood cells (WBC) less than 4/nl or platelet count less than 100/nl
- •11. History of organ transplantation
- •12. Anticipated non-compliance with the protocol
- •13. Pregnancy
- •14. Participation in another clinical trial
- •15. Clinical signs of congestive heart failure or left ventricular ejection fraction less than 40%
- •16. Uncontrolled hypertension (blood pressure more than 180/105 mmHg)
- •17. Orthostatic hypotension (supine systolic blood pressure less than 90 mmHg)
- •18. Treatment with clopidogrel or ticlopidine within the last 28 days prior to study start
- •19. Initiation of treatment with angiotensin converting enzyme (ACE) inhibitor, statin or calcium channel blocker within previous 2 weeks
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