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

Browse trials for

• Heart Diseases 3,639
• Angina Pectoris 519
• Coronary Disease 2,839
• Coronary Artery Disease 5,598
• Myocardial Ischemia 3,233
• Angina, Stable 345

Keywords

• Nicorandil
• Stable angina

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 402 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.

Study arms

• Experimental
  Standard treatment plus nicorandil

  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).

  Drug: Nicorandil · Drug: Standard Treatment

• Other
  Standard treatment

  Drug: Standard Treatment

Interventions

• DrugNicorandil

  The subjects will receive Nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with the standard treatment.

• DrugStandard 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.

Primary outcomes

1. Number of Myocardial Ischemia Attacks in 24 Hours

   Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (\>=) 0.1 millivolts (mV), and lasted for \>= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia.

   Time frame: At Week 12

Secondary outcomes

1. Change From Baseline in Total Myocardial Ischemic Burden at Week 12

   The total myocardial ischemic burden was defined as the product of the decrease, total array and total time of ST-segment in symptomatic and asymptomatic myocardial ischemia subjects within 24 hours.

   Time frame: Baseline, Week 12

2. Change From Baseline in Maximum ST-depression at Week 12

   The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. Absolute value of maximum ST-depression was used for calculation.

   Time frame: Baseline, Week 12

3. Change From Baseline in Longest Duration of ST Segment Depression at Week 12

   The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. The longest duration of ST segment depression of all leads for all the subjects with myocardial ischemia attack.

   Time frame: Baseline, Week 12

4. Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test

   The percentage of subjects who experienced ischemic heart attack during the Six-minute walk test (6-MWT) were evaluated.The 6-MWT was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.

   Time frame: At Week 12

5. Heart Rate Variability (HRV) Rate: Time Domain

   HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. Standard deviation of all NN intervals (SDNN) and Standard deviation of the averages of NN intervals (SDANN) are the two time domain methods used to determine heart rate variability. Two variants of the SDNN, created by dividing the 24-hour monitoring period into 5-minute segments, are the SDNN index and the SDANN index. The SDNN index is the mean of all the 5-minute standard deviations of NN (normal RR) intervals during the 24-hour period, while the SDANN index is the standard deviation of all the 5-minute NN interval means.

   Time frame: At Week 12

6. Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour

   HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. The HRV was evaluated based on frequency domain power-24 hours.

   Time frame: At Week 12

7. Number of Arrhythmia Occurred Within 24 Hours

   The number of ventricular tachycardia and premature ventricular beats that occurred within 24 hours.

   Time frame: At Week 12

8. ECG QT Dispersion

   The ECG QT dispersion was defined as the difference between the longest (QTmax) and the shortest (QTmin) QT intervals within a 12-lead ECG.

   Time frame: At Week 12

9. Number of Subjects Experienced Angina Attack

   Time frame: Baseline up to 12 Weeks

10. Frequency of Angina Attack

    The total number of times angina attacks occurred within a week (number of times/week)

    Time frame: At Week 12

11. Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin

    Time frame: At Week 12

12. Number of Nitroglycerin Tablets Consumed in a Week

    Time frame: At Week 12

13. Walk Distance in Six Minute Walk (6-MWT) Test at Week 12

    The 6-MWT distance was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.

    Time frame: At Week 12

14. 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

    An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

    Time frame: From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks )

15. Number of Subjects Who Showed Compliance to Nicorandil

    Compliance percent (%) was calculated by using the formula: (actual total dose divided by planned total dose) multiplied by 100. If subject compliance was less than 80% or greater than 120%, then that subject was considered as non compliant. The compliance of subjects taking nicorandil was evaluated.

    Time frame: Baseline up to 12 Weeks

Baseline characteristics

Publications

• 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. PubMed 27657471 ↗