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

NCT01396395 | Completed Phase 4 Results

• 1 other identifier: EMR200101-501
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina; Coronary Disease

Keywords

Nicorandil; Stable angina

Outcome Measures

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.

  At Week 12

Secondary Outcomes (15)

• Change From Baseline in Total Myocardial Ischemic Burden at Week 12

  Baseline, Week 12

• Change From Baseline in Maximum ST-depression at Week 12

  Baseline, Week 12

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

  Baseline, Week 12

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

  At Week 12

• Heart Rate Variability (HRV) Rate: Time Domain

  At Week 12

Study Arms (2)

Standard treatment plus nicorandil

EXPERIMENTAL

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

Standard treatment

OTHER

Drug: Standard Treatment

Interventions

Nicorandil DRUG

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

Standard treatment plus nicorandil

Standard Treatment DRUG

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.

Standard treatment; Standard treatment plus nicorandil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Co., Ltd., China: collaborator

Study Sites (1)

For Locations in

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 27657471 DERIVED

MeSH Terms

Conditions

Angina, Stable; Coronary Disease

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 18, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 14, 2016
• Results First Posted: April 14, 2016

Record last verified: 2016-03

Locations

CN (1)