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

Coronary Disease Clinical Trial

Official title:

A Prospective, Multi-center, Random, Open-label Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396395
• Other study ID #: EMR200101-501
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2011
• Last updated: September 9, 2014
• Start date: July 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study of 403 cases of stable angina patients who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Patients who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory ECG (Holter) examination and whose results are positive will go into the treatment period. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5mg (3 times a day = tid) on top of the standard treatment for 3 months, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient 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% stenosis detected by angiography

4. ETT (Exercise Tolerance Testing) or Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms.

• Patient must have more than 2 ischemic attacks detected by 24-hr Holter in recent 1 month or in screening period.

Exclusion Criteria:

• coronary syndrome or considering acute coronary syndrome (ACS)

• Left main coronary artery disease without revascularization

• Aortic stenosis

• Obstructive hypertrophic cardiomyopathy

• Patients with hypertension (SBP(systolic blood pressure)>170 mmHg or DBP(diastolic blood pressure)>100 mmHg) or hypotension (SBP<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 Sulphonylurea, PDE-5 inhibitor such as sildenafil, Trimetazidine for treatment of angina pectoris.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Stable Angina

Intervention

Drug:
• Nicorandil
Nicorandil 5 mg will be administered 3 times a day (tid)

Locations

Country	Name	City	State
China	For Recruiting Locations in	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Co., Ltd., China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ischemic attacks measured by 24-hour holter monitoring		12 weeks	No
Secondary	Number of participants with adverse events		12 weeks	Yes