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

Mashhad University of Medical Sciences

Status and phase: Completed; Phase 4

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

Treatments: Drug: Nicorandil; Drug: Nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT02254252

12604

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

54 participants in 2 patient groups

Nitroglycerin

Active Comparator group

Description:

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)

Treatment:

Drug: Nitroglycerin

Nicorandil

Active Comparator group

Description:

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)

Treatment:

Drug: Nicorandil