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

Angina Pectoris Clinical Trial

— SIGMART  

Official title:

A Clinical Trial to Assess the Efficacy of Sigmart in Patients With Recurrent Angina After Coronary Revascularization

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01185015
• Other study ID #: 200101-500
• Status: Withdrawn
• Phase: Phase 4
• First received: August 18, 2010
• Last updated: July 1, 2014
• Start date: January 2011

Study information

• Verified date: July 2012
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	until day 28	No
Secondary	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	until day 28	No
Secondary	Consumption of nitroglycerine (NTG).	Weekly assessment of NTG consumption until visit 4 (day 28)	until day 28	No
Secondary	Adverse events	The incidence of adverse events (especially the incidence of headache)	until day 28	Yes
Secondary	Compliance	Compliance % ([total number of tablets taken divided by the total number of tablets to be taken] multiplied by 100)	until day 28	No
Secondary	Number of angina attacks per week	Weekly assessment of angina attacks until day 28	until day 28	No