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临床试验/NCT02547597
NCT02547597已完成4 期

Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris

Gachon University Gil Medical Center1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
99
试验地点
1
主要终点
Time to onset of angina

研究概览

简要总结

There are few data regarding anti-anginal effects between beta-blockers with and without vasodilating property. Beta-blocker without vasodilating property is generally known to have unfavorable effects on glucose and lipid metabolism. Therefore, the investigators compared carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina pectoris.

详细描述

Previous studies have demonstrated that beta-blockers are effective in reducing not only ischemia but also cardiovascular mortality following myocardial infarction. And, recent guidelines have suggested the potential for use of beta-blockers as first-line agents in chronic stable angina. However, beta-blockers are a diverse class with different mechanisms of action and physiological effects. Various pharmacologic properties that characterize beta-blockers include cardioselectivity, intrinsic sympathomimetic activity, and concomitant vasodilating alpha-adrenoceptor blockade, which might exhibit differential anti-anginal efficacies. In addition, traditional beta-blockers, particularly nonvasodilating beta-blockers, have been reported to have negative metabolic effects, including hyperglycemia, insulin resistance, and dyslipidemia. These unfavorable effects of beta-blockers should be considered in patients with stable angina pectoris, because the pathophysiology of coronary artery disease is associated with abnormalities in glucose and lipid metabolism. Carvedilol, a newer vasodilating beta-blocker, has been shown to differ from traditional beta-blockers in terms of metabolic effects in patients with hypertension and diabetes. However, few data regarding comparative anti-anginal and metabolic effects between beta-blockers with and without vasodilating property have been reported, particularly in patients with angina pectoris. In this study, we simultaneously compared anti-anginal and metabolic effects of carvedilol and atenolol in patients with stable angina pectoris.

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
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable angina pectoris who had a positive exercise treadmill test according to the American College of Cardiology Foundation and the American Heart Association guidelines

排除标准

  • Acute coronary syndrome
  • Coronary revascularization within the past 3 months
  • Asthma or chronic obstructive lung disease
  • Bradycardia (heart rate < 55 beat/min)
  • History of severe adverse reaction to beta-blockers
  • Symptomatic arrhythmia requiring anti-arrhythmia therapy
  • Heart failure
  • Severe renal or hepatic failure

研究组 & 干预措施

Carvedilol

Experimental

Carvedilol 25 mg twice a day

干预措施: Carvedilol (Drug)

Atenolol

Active Comparator

Atenolol 50 mg twice a day

干预措施: Atenolol (Drug)

结局指标

主要结局

Time to onset of angina

时间窗: After 25 weeks of treatment

Time to onset of angina at exercise treadmill test

Time to 1-mm ST-segment depression

时间窗: After 25 weeks of treatment

Time to 1-mm ST-segment depression at exercise treadmill test

次要结局

  • Seattle Angina Questionnaire (SAQ) scores(After 25 weeks of treatment)
  • Heart rate at resting and peak exercise(After 25 weeks of treatment)
  • Blood pressure at resting and peak exercise(After 25 weeks of treatment)
  • Lipid profiles(After 25 weeks of treatment)
  • Glucose metabolism(After 25 weeks of treatment)
  • Treatment-emergent adverse events(After 25 weeks of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Woong Chol Kang

Associate professor

Gachon University Gil Medical Center

研究点 (1)

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