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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
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
Time frame: until day 28
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
Time frame: until day 28
Consumption of nitroglycerine (NTG).
Weekly assessment of NTG consumption until visit 4 (day 28)
Time frame: until day 28
Adverse events
The incidence of adverse events (especially the incidence of headache)
Time frame: until day 28
Compliance
Compliance % (\[total number of tablets taken divided by the total number of tablets to be taken\] multiplied by 100)
Time frame: until day 28
Number of angina attacks per week
Weekly assessment of angina attacks until day 28
Time frame: until day 28
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