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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01396395
• Date of registration: 15/07/2011
• Primary sponsor: Merck KGaA
• Public title: Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
• Scientific title: A Prospective, Multi-center, Random, Open-label Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
• Date of first enrolment: July 2011
• Target sample size: 400
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01396395
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Merck KGaA Communication Center

• Name: Merck KGaA Communication Center

• Name: Yong Huo
• Affiliation: Peking University First Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Disease

Stable Angina

Intervention(s)

Drug: Nicorandil

Primary Outcome(s)

Number of ischemic attacks measured by 24-hour holter monitoring [Time Frame: 12 weeks]

Secondary Outcome(s)

Number of participants with adverse events [Time Frame: 12 weeks]

Secondary ID(s)

EMR200101-501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Serono Co., Ltd., China