To Assess the Anti-anginal Safety and Efficacy of Ivabradine in Subjects With Stable,Symptomatic Chronic Angina
Unknown statusPhase 2NCT02623569
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Arms Assigned Interventions Experimental: Ivabradine Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day when positive ETT and HR\>60times/min or negative ETT and HR\>80times/min of subjects. Active Comparator: Atenolol Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and heard rate\>60times/min or negative ETT and HR \>80times/min of subjects.
Study details
- Official title
- Evaluation of the Anti-anginal Efficacy and Safety of Ivabradine Used in Patients With Stable Effort Angina Pectoris. A 12 Weeks Randomised, Double-blind Controlled, Parallel-group, Multicentre Study
- Conditions
- Interventions
- Drug: Ivabradine
- Drug: Atenolol
- Sponsor
- Xintong Pharmacy Company
- Start date
- 2014-10
- Primary completion
- 2017-06
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. male or female aged 18 to 75 years 2. Clearly understand the study and participate in it voluntarily; the informed consent should be signed in person or by legal guardian. 3. Chronic Stable Angina was confirmed by clinic over 3 months. 4. Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions: * Patients who have a history of myocardial infarction over 3 months. * Patients who have received coronary intervention or CABG(Coronary Artery Bypass Grafting) over 6 months. * Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph. * Ischemic electrocardiogram changes:ST-segment depression ≥ 1.0 mm compared with P-R or elevate≥1.0 mm during exercise ECG Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms 5. ultrasonic cardiogram disclosed that left ventricular ejection fraction ≥50 %. 6. Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening. Exclusion Criteria: 1. Clinically significant Valvular disease, congenital heart disease, pulmonary hypertension, cerebral apoplexy, dissecting aneurysm, hypertrophic cardiomyopathy, acute myocarditis/cp. 2. Patients with myocardial infarction within the preceding 3 months 3. Patients have received Coronary angioplasty or CABG within the preceding 6 months. 4. Patients who have severity vessels disease with left main coronary artery but have no valid treatment. 5. Patients with congestive heart failure(New York Heart Association class III or IV)or acute pulmonary edema. 6. Patients whose rest heart rate\< 60 bpm. 7. Patients with nonrespiratory sinus arrhythmia or arrhythmia(e.g.,AVB(auriculo-ventricular block)ⅡⅢ,atrial fibrillation,atrial flutter,SSS(sick sinus syndrome)) or implantable cardiac defibrillator (ICD). 8. Patient with any conditions that interfered the performance of exercise tolerance test or a history of an abnormal exercise response limited by electrocardiograph (ECG) changes. 9. Patient with uncontrolled hypertension (seated systolic blood pressure (SBP)≥180 mmHg or diastolic blood pressure (DBP) ≥100 mmHg); SBP\<90 mmHg and/or DBP\<60 mmHg 10. Diabetic with uncontrolled blood glucose(FBG≥11.1 mmol/L and/or RBG≥13.6 mmol/L) 11. Patients with anemia(male:Hb≤120 g/L;female:Hb≤110 g/L) 12. Patients complicated with systemic disea…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02623569