Phase 4
N=402
Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
Stable Angina · Coronary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01396395 ↗Enrolled (actual)
402
Serious AEs
4.0%
Results posted
Apr 2016
Primary outcome: Primary: Number of Myocardial Ischemia Attacks in 24 Hours — 2.3; 3.8 ischemic attacks per 24 hours — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicorandil (Drug); Standard Treatment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Myocardial Ischemia Attacks in 24 Hours |
2.3; 3.8 | <0.0001 sig |
| SECONDARY Change From Baseline in Total Myocardial Ischemic Burden at Week 12 |
-38.63; 29.26 | — |
| SECONDARY Change From Baseline in Maximum ST-depression at Week 12 |
0.25; 0.36 | — |
| SECONDARY Change From Baseline in Longest Duration of ST Segment Depression at Week 12 |
-3.8; 3.4 | — |
| SECONDARY Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test |
2.2; 4.1 | — |
| SECONDARY Heart Rate Variability (HRV) Rate: Time Domain |
126.1; 125.7; 116.9; 116.7; 47.6; 47.0 | — |
| SECONDARY Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour |
2397.0; 2328.6 | — |
| SECONDARY Number of Arrhythmia Occurred Within 24 Hours |
0.8; 5.2; 134.8; 569.1 | — |
| SECONDARY ECG QT Dispersion |
0.1298; 0.1110 | — |
| SECONDARY Number of Subjects Experienced Angina Attack |
48; 70 | — |
| SECONDARY Frequency of Angina Attack |
1; 2 | — |
| SECONDARY Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin |
20; 43 | — |
| SECONDARY Number of Nitroglycerin Tablets Consumed in a Week |
1; 2 | — |
| SECONDARY Walk Distance in Six Minute Walk (6-MWT) Test at Week 12 |
452.1; 438.1 | — |
| SECONDARY 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 |
23; 13; 9; 7; 1; 1 | — |
| SECONDARY Number of Subjects Who Showed Compliance to Nicorandil |
181 | — |
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:
- A history of coronary revascularization Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery at least 3 months ago
- Myocardial infarction
- More than 50 percent (%) stenosis detected by angiography
- 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
Data sourced from ClinicalTrials.gov (NCT01396395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.