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

NCT ID: NCT02254252

Last Updated: 2015-03-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Slow coronary flow phenomenon Angina pectoris chest pain nicroandil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Nitroglycerin

Intervention Type DRUG

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

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)

Group Type ACTIVE_COMPARATOR

Nicorandil

Intervention Type DRUG

nicorandil (10mg tablets, two times a day)

Interventions

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Nicorandil

nicorandil (10mg tablets, two times a day)

Intervention Type DRUG

Nitroglycerin

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Pouya Nezafati

Dr. Pouya Nezafati

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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12604

Identifier Type: -

Identifier Source: org_study_id