ISRCTN34110682已完成不适用
Effect of coadministration of ezetimibe with statin therapy versus statin therapy alone on flow mediated vasodilation in patients with coronary artery disease
Johannes Gutenberg-University Mainz (Germany)0 个研究点目标入组 58 人开始时间: 2008年9月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
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. Both males and females, over 18 years old
- •2. Angiographic, documented coronary heart disease with:
- •a. Generalized wall irregularities (stenosis <40%) and/or
- •b. Existence of at least one stenosis >50%
- •3. Endothelial dysfunction with flow-dependent dilation of the brachial artery of <6%
- •4. LDL cholesterol >100 mg/dl
- •5. Written consent of the patients for participation in the study
排除标准
- •1. Acute coronary syndrome
- •2. Stroke or peripheral revascularisation within 12 weeks before study enrolment
- •3. Known intolerance towards HMG CoA reductase inhibitors or ezetimibe
- •4. Clinically significant valvular disease
- •5. Hypertrophic obstructive cardiomyopathy
- •6. Sustained ventricular arrhythmias
- •7. Syncope within four weeks before the study
- •8. Severe respiratory disease
- •9. Unstable diabetes mellitus requiring frequent adjustments in insulin doses
- •10. Known hypothyroidism
- •11. Known hyperthyroidism
- •12. Gastrointestinal disorders (such as Crohn's disease), which could lead to decreased absorption of the study drug
- •13. Chronic liver disease
- •14. History of pancreatitis
- •15. History of organ transplantation
- •16. Clinically significant heart failure with left ventricular ejection fraction of <30%
- •17. Symptoms of orthostatic hypotension, or a systolic blood pressure in the supine position of <90 mmHg
- •18. Systolic blood pressure >180 mmHg and/or diastolic blood pressure >105 mmHg despite antihypertensive therapy
- •19. Elevated serum creatinine of >2.0 mg/dL or known nephrotic syndrome
- •20. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times above the upper normal limit
- •21. Triglyceride level >400 mg/dl
- •22. Treatment with an HMG CoA reductase inhibitor during the last three months
- •23. Treatment with ezetimibe during the last three months
- •24. Initiation of treatment with an angiotensin converting enzyme (ACE) inhibitor, AT1-receptor antagonist, or calcium channel blocker within the past four weeks
- •25. Treatment with fibrates or colestipol during the last three months
- •26. Current treatment with macrolide antibiotics, niacin or antimycotics of azole type
- •27. Expected problems with compliance or follow-up visits (no fixed residence, alcohol or drug abuse, history of failure of medical advice, psychiatric diseases, etc.)
- •28. For women: pregnancy, breast feeding or possible pregnancy (women of childbearing age on an acceptable method of contraception may be included)
- •29. Simultaneous participation in another study
- •30. Therapy with another investigational product within a period of 30 days before the study
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