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A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization (SIGMART)

Primary Purpose

Angina Pectoris

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sigmart (nicorandil)
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring Angina Pectoris, Coronary disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects should be 18~70 years old, male or female
  • Subjects should have a history of coronary revascularization at least 6 months ago
  • Subjects should present with typical angina or similar to the chest pain before prior coronary revascularization for at least 1 month
  • Subjects should be relieved from anginal attacks with short-acting NTG
  • Subjects should have the ability to withhold medication which cannot be concomitant in this clinical study during the study
  • Subjects should have an ability to give written informed consent

Exclusion Criteria:

  • Unstable angina
  • Left main coronary artery disease
  • Aortic stenosis
  • Obstructive hypertrophic cardiomyopathy
  • Subjects with hypertension (SBP>170 mmHg or DBP>100 mmHg) or hypotension (SBP<90 mmHg or DBP<60 mmHg)
  • Postural hypotension (drop in systolic blood pressure >20% after 2 minute standing),
  • Congestive heart failure (NYHA class III - IV)
  • Ejection fraction (EF)<45% by Echocardiography
  • Peripheral arterial obstructive disease or other diseases limiting exercise testing
  • Arrhythmias requiring active treatment
  • Gastro-intestinal ulcer
  • Liver dysfunction (defined as ALT or bilirubin>1.5×upper limit of normal value)
  • Significant renal impairment, such as serum creatinine greater than 1.5 folds the upper limit of normal as determined by local clinical laboratory
  • Glaucoma
  • Concomitant medication such as Trimetazidine, Sulphonylurea, PDE-5 inhibitor such as sildenafil, Chinese traditional medicine for treatment of angina pectoris
  • Known intolerance to nitrates
  • Known allergic to nicotinic acid
  • Pregnant or lactating women
  • Any other contraindications mentioned in the SPC
  • Participation in another clinical study within the last 3 months
  • Legal incapacity or limited legal capacity
  • Any other subjects assessed by the investigator as being unsuitable for the present study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Time to 1 mm ST-depression
    It is defined as the exercise time to develop 1 mm ST-segment depression in the same identified leads

    Secondary Outcome Measures

    Exercise tolerance test parameters
    Exercise Tolerance Test (ETT) parameters include: Total exercise time Time to onset of chest pain using ETT Maximum ST-depression SBP × HR (Pressure Rate Product) Metabolic Equivalents (METs) ETT grade and Score
    Consumption of nitroglycerine (NTG).
    Weekly assessment of NTG consumption until visit 4 (day 28)
    Adverse events
    The incidence of adverse events (especially the incidence of headache)
    Compliance
    Compliance % ([total number of tablets taken divided by the total number of tablets to be taken] multiplied by 100)
    Number of angina attacks per week
    Weekly assessment of angina attacks until day 28

    Full Information

    First Posted
    August 18, 2010
    Last Updated
    July 1, 2014
    Sponsor
    Merck KGaA, Darmstadt, Germany
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01185015
    Brief Title
    A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization
    Acronym
    SIGMART
    Official Title
    A Clinical Trial to Assess the Efficacy of Sigmart in Patients With Recurrent Angina After Coronary Revascularization
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Merck KGaA, Darmstadt, Germany

    4. Oversight

    5. Study Description

    Brief Summary
    The multi-centric, open label, single arm and self controlled study is planned to assess the efficacy of orally administered Sigmart in subjects with recurrent angina after coronary revascularization. The primary objective of this study is to demonstrate that orally administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent angina subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Angina Pectoris
    Keywords
    Angina Pectoris, Coronary disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Sigmart (nicorandil)
    Other Intervention Name(s)
    Sigmart®
    Intervention Description
    Sigmart will be administered for 2 weeks when the subject enters the secondary treatment period (Day 15 to approximately Day 28), at the dosage of 5 mg per oral tid in addition to the previous anti-anginal regimen.
    Primary Outcome Measure Information:
    Title
    Time to 1 mm ST-depression
    Description
    It is defined as the exercise time to develop 1 mm ST-segment depression in the same identified leads
    Time Frame
    until day 28
    Secondary Outcome Measure Information:
    Title
    Exercise tolerance test parameters
    Description
    Exercise Tolerance Test (ETT) parameters include: Total exercise time Time to onset of chest pain using ETT Maximum ST-depression SBP × HR (Pressure Rate Product) Metabolic Equivalents (METs) ETT grade and Score
    Time Frame
    until day 28
    Title
    Consumption of nitroglycerine (NTG).
    Description
    Weekly assessment of NTG consumption until visit 4 (day 28)
    Time Frame
    until day 28
    Title
    Adverse events
    Description
    The incidence of adverse events (especially the incidence of headache)
    Time Frame
    until day 28
    Title
    Compliance
    Description
    Compliance % ([total number of tablets taken divided by the total number of tablets to be taken] multiplied by 100)
    Time Frame
    until day 28
    Title
    Number of angina attacks per week
    Description
    Weekly assessment of angina attacks until day 28
    Time Frame
    until day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects should be 18~70 years old, male or female Subjects should have a history of coronary revascularization at least 6 months ago Subjects should present with typical angina or similar to the chest pain before prior coronary revascularization for at least 1 month Subjects should be relieved from anginal attacks with short-acting NTG Subjects should have the ability to withhold medication which cannot be concomitant in this clinical study during the study Subjects should have an ability to give written informed consent Exclusion Criteria: Unstable angina Left main coronary artery disease Aortic stenosis Obstructive hypertrophic cardiomyopathy Subjects with hypertension (SBP>170 mmHg or DBP>100 mmHg) or hypotension (SBP<90 mmHg or DBP<60 mmHg) Postural hypotension (drop in systolic blood pressure >20% after 2 minute standing), Congestive heart failure (NYHA class III - IV) Ejection fraction (EF)<45% by Echocardiography Peripheral arterial obstructive disease or other diseases limiting exercise testing Arrhythmias requiring active treatment Gastro-intestinal ulcer Liver dysfunction (defined as ALT or bilirubin>1.5×upper limit of normal value) Significant renal impairment, such as serum creatinine greater than 1.5 folds the upper limit of normal as determined by local clinical laboratory Glaucoma Concomitant medication such as Trimetazidine, Sulphonylurea, PDE-5 inhibitor such as sildenafil, Chinese traditional medicine for treatment of angina pectoris Known intolerance to nitrates Known allergic to nicotinic acid Pregnant or lactating women Any other contraindications mentioned in the SPC Participation in another clinical study within the last 3 months Legal incapacity or limited legal capacity Any other subjects assessed by the investigator as being unsuitable for the present study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cherry Ma, PhD
    Organizational Affiliation
    Beijing Merck Pharmaceutical Consulting Ltd., China
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization

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