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

Last updated: March 15, 2016
Sponsor: Merck KGaA, Darmstadt, Germany
Overall Status: Completed

Phase

4

Condition

Coronary Artery Disease

Myocardial Ischemia

Thrombosis

Treatment

N/A

Clinical Study ID

NCT01396395
EMR200101-501
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

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

  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) showedmore than 50% stenosis with typical angina symptoms

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

Exclusion

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 (>) 170millimeters of mercury (mmHg) or diastolic blood pressure (DBP) >100 mmHg) orhypotension (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 exclusioncriteria could apply

Study Design

Total Participants: 402
Study Start date:
September 01, 2011
Estimated Completion Date:
May 31, 2014

Connect with a study center

  • For Locations in

    Beijing,
    China

    Site Not Available

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