Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina (SIGMART)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Stable Angina; Coronary Disease

Treatments: Drug: Nicorandil; Drug: Standard Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396395

EMR200101-501

Details and patient eligibility

About

This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of the standard treatment for 12 weeks, while the control group will stay on standard treatment. Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not affect the primary endpoint may be adjusted per investigators decision.

Enrollment: 402 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be diagnosed as stable CHD, and must have at least one of these histories:

  1. A history of coronary revascularization Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery at least 3 months ago
  2. Myocardial infarction
  3. More than 50 percent (%) stenosis detected by angiography
  4. Exercise Tolerance Testing (ETT) or Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms

• Subjects must have at least 2 times of typical symptoms of myocardial ischemia occurred within a week Other protocol defined inclusion criteria could apply

Exclusion criteria

• Coronary syndrome or considering acute coronary syndrome (ACS)
• Left main coronary artery disease without revascularization
• Aortic stenosis
• Obstructive hypertrophic cardiomyopathy
• Subjects with hypertension systolic blood pressure (SBP) greater than (>) 170 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) >100 mmHg) or hypotension (SBP less than [<] 90 mmHg or DBP<60 mmHg)
• Diagnosis as postural hypotension before
• Congestive heart failure (New York Heart Association [NYHA] class III - IV
• Ejection fraction (EF)<40% by Echocardiography
• Arrhythmias requiring active treatment
• Gastro-intestinal ulcer
• Concomitant medication such as Sulphonyl urea, PDE-5 inhibitor such as sildenafil, Trimetazidine for treatment of angina pectoris Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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402 participants in 2 patient groups

Standard treatment plus nicorandil

Experimental group

Description:

The subjects will receive nicorandil 5 milligram (mg ) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (such as aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \[(ACEIs\] as permitted by disease condition /as per standard local practices/prescribed per discretion of investigators).

Treatment:

Drug: Standard Treatment

Drug: Nicorandil

Standard treatment

Other group

Treatment:

Drug: Standard Treatment