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

NCT01185015 | Withdrawn Phase 4

• 1 other identifier: 200101-500
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Angina Pectoris, Coronary disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Exercise tolerance test parameters

  until day 28

• Consumption of nitroglycerine (NTG).

  until day 28

• Adverse events

  until day 28

• Compliance

  until day 28

• Number of angina attacks per week

  until day 28

Interventions

Sigmart (nicorandil) DRUG

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.

Also known as: Sigmart®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

MeSH Terms

Conditions

Angina Pectoris; Coronary Disease

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Cherry Ma, PhD

  Beijing Merck Pharmaceutical Consulting Ltd., China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 19, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2011
• Last Updated: July 2, 2014

Record last verified: 2012-07