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

Information source: Mashhad University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Slow Coronary Flow; Normal, or Near Normal Coronary Angiography; Stable Angina

Intervention: Nicorandil (Drug); Nitroglycerin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Mashhad University of Medical Sciences

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

Angina Episode Frequnecy

Angina Episode Intensity

Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris

Secondary outcome: Side-effects

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: March 2012
Last updated: March 28, 2015

Page last updated: August 23, 2015

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