Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT01396395
Eligibility Criteria:
Inclusion Criteria:
* Subject 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 percent (%) stenosis detected by angiography
4. Exercise Tolerance Testing (ETT) or Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms
* Subjects must have at least 2 times of typical symptoms of myocardial ischemia occurred within a week Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* 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
* Concomitant medication such as Sulphonyl urea, PDE-5 inhibitor such as sildenafil, Trimetazidine for treatment of angina pectoris Other protocol defined exclusion criteria could apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01396395
Study Brief:
Protocol Section:
NCT01396395