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

Merck KGaA (EMD Serono)

Status and phase

Withdrawn

Phase 4

Conditions

Angina Pectoris

Treatments

Drug: Sigmart (nicorandil)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01185015

200101-500

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No 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