Angina Pectoris
Conditions
Keywords
Angina Pectoris, Coronary disease
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.
Interventions
DRUGSigmart (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.
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to 1 mm ST-depression | until day 28 | It is defined as the exercise time to develop 1 mm ST-segment depression in the same identified leads |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise tolerance test parameters | until day 28 | 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). | until day 28 | Weekly assessment of NTG consumption until visit 4 (day 28) |
| Adverse events | until day 28 | The incidence of adverse events (especially the incidence of headache) |
| Compliance | until day 28 | 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 | until day 28 | Weekly assessment of angina attacks until day 28 |
Outcome results
None listed