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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254252
Recruitment Status : Completed
First Posted : October 1, 2014
Results First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Pouya Nezafati, Mashhad University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Slow Coronary Flow Normal, or Near Normal Coronary Angiography Stable Angina Drug: Nicorandil Drug: Nitroglycerin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Active Comparator: 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)
Drug: Nitroglycerin
sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)

Active Comparator: 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)
Drug: Nicorandil
nicorandil (10mg tablets, two times a day)




Primary Outcome Measures :
  1. Angina Episode Frequnecy [ Time Frame: 1 month ]
    One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.

  2. Angina Episode Intensity [ Time Frame: 1 month ]
    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.

  3. Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris [ Time Frame: 1 month ]
    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 :
  1. Side-effects [ Time Frame: 1 month ]
    Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Pouya Nezafati, Dr. Pouya Nezafati, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02254252    
Other Study ID Numbers: 12604
First Posted: October 1, 2014    Key Record Dates
Results First Posted: March 31, 2015
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Pouya Nezafati, Mashhad University of Medical Sciences:
Slow coronary flow phenomenon
Angina pectoris
chest pain
nicroandil
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nicorandil
Nitroglycerin
Vasodilator Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs