Clinical trial NCT01396395: Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
Official title: A Prospective, Multi-center, Random, Open-label Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Angina
Coronary Disease
Keywords: Nicorandil
Stable angina
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Co., Ltd., China
First posted: 2011-07-18
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Myocardial Ischemia Attacks in 24 Hours
timeFrame: At Week 12
Secondary outcomes:
measure: Change From Baseline in Total Myocardial Ischemic Burden at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Maximum ST-depression at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Longest Duration of ST Segment Depression at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test
timeFrame: At Week 12
measure: Heart Rate Variability (HRV) Rate: Time Domain
timeFrame: At Week 12
measure: Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour
timeFrame: At Week 12
measure: Number of Arrhythmia Occurred Within 24 Hours
timeFrame: At Week 12
measure: ECG QT Dispersion
timeFrame: At Week 12
measure: Number of Subjects Experienced Angina Attack
timeFrame: Baseline up to 12 Weeks
measure: Frequency of Angina Attack
timeFrame: At Week 12
measure: Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin
timeFrame: At Week 12
measure: Number of Nitroglycerin Tablets Consumed in a Week
timeFrame: At Week 12
measure: Walk Distance in Six Minute Walk (6-MWT) Test at Week 12
timeFrame: At Week 12
measure: Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation
timeFrame: From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks )
measure: Number of Subjects Who Showed Compliance to Nicorandil
timeFrame: Baseline up to 12 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: For Locations in
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Jiang J, Li Y, Zhou Y, Li X, Li H, Tang B, Dai X, Ma T, Li L, Huo Y. Oral nicorandil reduces ischemic attacks in patients with stable angina: A prospective, multicenter, open-label, randomized, controlled study. Int J Cardiol. 2016 Dec 1;224:183-187. doi: 10.1016/j.ijcard.2016.08.305. Epub 2016 Aug 21.