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临床试验/NCT02254252
NCT02254252已完成4 期

Nicorandil Versus Nitroglycerin for Symptomatic Relief of Angina in Patients With Slow Coronary Flow Phenomenon Visited in Imam Reza Hospital, Mashhad, Iran

Mashhad University of Medical Sciences0 个研究点目标入组 54 人开始时间: 2012年3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
54
主要终点
Angina Episode Intensity

研究概览

简要总结

Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed opacification of epicardial arteries in the absence of significant arterial narrowing and blockade. Endothelial dysfunction at the level of microarteries have been proposed as the main pathological mechanism in this regard. Available evidence suggest that standard anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is hypothesized that anti-angina medications which exert vasodilatory effects in large coronary arteries as well as small dividing branches might be superior to nitroglycerin in amelioration of angina symptoms. The present randomized clinical trial was thus designed and conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina medication with effects on both large and small coronary vessels) with nitroglycerin in a group of patients with slow coronary flow presented with frequent angina episodes.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • on coronary angiographic studies, arterial narrowing did not exceed 50% in any of the three main coronary arteries; (
  • a delayed opacification in at least one of the main coronary arteries was documented. Delayed opacification was defines as corrected TIMI frame count > 23 fps

排除标准

  • comorbid cardiovascular condition other than mild coronary atherosclerosis and coronary slow flow
  • refusal to participate
  • discontinuation of treatment
  • not returning for the follow up visit

研究组 & 干预措施

Nitroglycerin

Active Comparator

sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)

干预措施: Nitroglycerin (Drug)

Nicorandil

Active Comparator

nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)

干预措施: Nicorandil (Drug)

结局指标

主要结局

Angina Episode Intensity

时间窗: 1 month

One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.

Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris

时间窗: 1 month

One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient's description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).

Angina Episode Frequnecy

时间窗: 1 month

One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.

次要结局

  • Side-effects(1 month)

研究者

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

Pouya Nezafati

Dr. Pouya Nezafati

Mashhad University of Medical Sciences

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