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

NCT ID: NCT01185015

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31

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.

Conditions

Angina Pectoris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Sigmart®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Beijing Merck Pharmaceutical Consulting LTD, an affiliate of Merck KGaA, Darmstadt, Germany.

Principal Investigators

Cherry Ma, PhD

Role: STUDY_DIRECTOR

Beijing Merck Pharmaceutical Consulting Ltd., China

Other Identifiers

200101-500

Identifier Type: -

Identifier Source: org_study_id