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

Phase 4

Withdrawn

• Conditions: Angina Pectoris

• Registration Number: NCT01185015
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Study Start: 2011-01
• Primary Completion: 2011-01
• Status Verified: 2012-07
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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