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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Serono Co., Ltd., China
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01396395
First received: July 15, 2011
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Stable Angina
Coronary Disease
Drug: Nicorandil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Random, Open-label Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Number of ischemic attacks measured by 24-hour holter monitoring [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 403
Study Start Date: July 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: basic therapy plus nicorandil Drug: Nicorandil
Nicorandil 5 mg will be administered 3 times a day (tid)
No Intervention: basic therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396395

Locations
China
For Recruiting Locations in
Beijing, China
Sponsors and Collaborators
Merck KGaA
Merck Serono Co., Ltd., China
Investigators
Principal Investigator: Yong Huo Peking University First Hospital
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01396395     History of Changes
Other Study ID Numbers: EMR200101-501
Study First Received: July 15, 2011
Last Updated: February 7, 2014
Health Authority: China: Ethics Committee

Keywords provided by Merck KGaA:
Nicorandil
Stable angina

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Nicorandil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014