Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow

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

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.

Study Overview

• Status: Completed
• Conditions: Stable Angina; Slow Coronary Flow; Normal, or Near Normal Coronary Angiography
• Intervention / Treatment: Drug: Nitroglycerin; Drug: Nicorandil

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nitroglycerin; 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)	Drug: Nitroglycerin; sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
Active Comparator: Nicorandil; 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)	Drug: Nicorandil; nicorandil (10mg tablets, two times a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angina Episode Frequnecy	One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.	1 month
Angina Episode Intensity	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.	1 month
Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris	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).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side-effects	Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications	1 month

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: September 29, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 28, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: chest pain; Angina pectoris; Slow coronary flow phenomenon; nicroandil
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Micronutrients; Vitamins; Vitamin B Complex; Nitroglycerin; Nicorandil
• Other Study ID Numbers: 12604