Phase 4
N=54
Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow
Slow Coronary Flow · Normal, or Near Normal Coronary Angiography · Stable Angina
Bottom Line
View on ClinicalTrials.gov: NCT02254252 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Angina Episode Frequnecy — 2.28; 1.68 episodes per week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicorandil (Drug); Nitroglycerin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Mashhad University of Medical Sciences
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Angina Episode Frequnecy |
2.28; 1.68 | — |
| PRIMARY Angina Episode Intensity |
3.89; 3.03 | — |
| PRIMARY Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris |
8; 19; 11; 4; 5; 2 | — |
| SECONDARY Side-effects |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02254252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.