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

NCT02254252 | Completed Phase 4 Results

• 1 other identifier: 12604
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Slow Coronary Flow; Normal, or Near Normal Coronary Angiography; Stable Angina

Keywords

Slow coronary flow phenomenon; Angina pectoris; chest pain; nicroandil

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Side-effects

  1 month

Study Arms (2)

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)

Drug: Nitroglycerin

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)

Drug: Nicorandil

Interventions

Nicorandil DRUG

nicorandil (10mg tablets, two times a day)

Nicorandil

Nitroglycerin DRUG

sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)

Nitroglycerin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris; Chest Pain

Interventions

Nicorandil; Nitroglycerin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Nitro Compounds

Results Point of Contact

• Title: Pouya Nezafati
• Organization: Mashhad University of Medical Sciences

nezafatip871@mums.ac.ir

00989151578421

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Pouya Nezafati

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 31, 2015
• Results First Posted: March 31, 2015

Record last verified: 2015-03