Impact of 12 weeks oral niacin on endothelial function, lipid composition and cardiovascular biomarkers in patients with coronary artery disease: a prospective, randomized, double-blind, placebo-controlled, monocentric clinical trial of phase IV

Johannes Gutenberg-University Mainz (Germany)0 个研究点目标入组 100 人开始时间: 2006年1月20日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Men or women > 35 and < 80 years of age
•2. Documented clinically stable CAD and known dyslipidemia, defined by a low-density lipoprotein cholesterol (LDL >70 mg/dl) and a high density lipoprotein cholesterol (HDL <65mg/dl)
•3. A flow-mediated vasodilatation (FMD) of less than 8%
•4. Ability of subject to understand character and individual consequences of clinical trial
•5. Written informed consent must be available before enrolment in the trial
•6. For women with childbearing potential, adequate contraception

•1. Clinical signs of congestive heart failure or left ventricular ejection fraction <30%
•2. Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <90 mmHg)
•3. Initiation of any of the following medications within the last twelve weeks: aspirin, lipid-lowering agents, calcium antagonists, betablockers, angiotensin converting enzymes inhibitors (ACEI) or angiotensin ?1 (AT1) receptor blockers, hormone replacement therapy
•4. Use of steroids or chemotherapy drugs within the past year or chronic use of non-steroidal anti-inflammatory drugs except for aspirin
•5. Hemodynamically significant valvular heart diseases or hypertrophic obstructive cardiomyopathy
•6. Renal dysfunction (creatinine > 2.5 mg/dl)
•7. Known hepatic disease or elevation of serum transaminases or gamma glutamyl transferase (gGT) > 2x ULN (upper limit of normal range)
•8. Uric acid >10.0 mg/dl
•9. Alcohol abuse
•10. White blood cell (WBC) count >12,000 or platelet count >500,000 /ul or <75,000 /ul
•11. Existence of acute gastric ulcers
•12. Existence of acute arterial bleeding
•13. Other significant laboratory abnormalities

发起方

Johannes Gutenberg-University Mainz (Germany)