Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow
Primary Purpose
Slow Coronary Flow, Normal, or Near Normal Coronary Angiography, Stable Angina
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nicorandil
Nitroglycerin
Sponsored by
About this trial
This is an interventional treatment trial for Slow Coronary Flow focused on measuring Slow coronary flow phenomenon, Angina pectoris, chest pain, nicroandil
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nitroglycerin
Nicorandil
Arm 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)
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)
Outcomes
Primary Outcome Measures
Angina Episode Frequnecy
One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.
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.
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).
Secondary Outcome Measures
Side-effects
Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications
Full Information
NCT ID
NCT02254252
First Posted
September 29, 2014
Last Updated
March 28, 2015
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02254252
Brief Title
Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Slow Coronary Flow, Normal, or Near Normal Coronary Angiography, Stable Angina
Keywords
Slow coronary flow phenomenon, Angina pectoris, chest pain, nicroandil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitroglycerin
Arm Type
Active Comparator
Arm 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)
Arm Title
Nicorandil
Arm Type
Active Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Intervention Description
nicorandil (10mg tablets, two times a day)
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
Primary Outcome Measure Information:
Title
Angina Episode Frequnecy
Description
One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.
Time Frame
1 month
Title
Angina Episode Intensity
Description
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.
Time Frame
1 month
Title
Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris
Description
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).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Side-effects
Description
Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow
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