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

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Trial to Assess the Efficacy of Sigmart in Patients With Recurrent Angina After Coronary Revascularization

Conditions
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Angina Pectoris

Intervention / Treatment
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* Drug: Sigmart (nicorandil)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sigmart (nicorandil)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | until day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | until day 28 | 
| Consumption of nitroglycerine (NTG). | Weekly assessment of NTG consumption until visit 4 (day 28) | until day 28 | 
| Adverse events | The incidence of adverse events (especially the incidence of headache) | until day 28 | 
| Compliance | Compliance % ([total number of tablets taken divided by the total number of tablets to be taken] multiplied by 100) | until day 28 | 
| Number of angina attacks per week | Weekly assessment of angina attacks until day 28 | until day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angina Pectoris, Coronary disease