Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
Condition: Stable Angina; Coronary Disease
MeSH terms: Heart Diseases; Angina Pectoris; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Angina, Stable
Intervention: Nicorandil; Standard Treatment
Intervention description: The subjects will receive Nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with the standard treatment.; The subjects will receive one of the standard anti-anginal therapies which included but not limited to aspirin, ACEI, lipid lowering statins and beta blockers according to the recommendation of guidelines. If the subject's condition permitted, they should take all these medicines. However, the dose, route, frequency and duration were determined by investigators according to subject's specific condition.
Intervention MeSH terms: Nicorandil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nicorandil; Stable angina

Summary:

      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.
    

Eligibility criteria:

        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