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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
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    September 29, 2014
    Last Updated
    March 28, 2015
    Sponsor
    Mashhad University of Medical Sciences
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    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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