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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.
If heart rate are low 50 times/min after taking Ivabradine 5mg/ Atenolol 12.5mg, subjects should withdrawal and dropped out study. If subjects heart rate are low 50 times/min after taking Ivabradine 7.5mg/ Atenolol 25mg, subjects should change the dose to Ivabradine 5mg/ Atenolol 12.5mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine | Experimental | Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day when positive ETT and HR(heard rate)>60times/min or negative ETT and HR(heard rate)>80times/min of subjects. |
|
| Atenolol | Active Comparator | Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and HR(heard rate)>60times/min or negative ETT and HR (heard rate)>80times/min of subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine | Drug | Not Provided |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is Change from total exercise duration in exercise tolerance test (ETT) | Baseline and end of treatment (Week 12) . |
| Measure | Description | Time Frame |
|---|---|---|
| Time to angina in exercise tolerance test. | 12 weeks | |
| Time to 1 mm ST-segment depression in exercise tolerance test | 12 weeks | |
| Number of angina attacks in exercise tolerance test per week |
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Inclusion Criteria:
male or female aged 18 to 75 years
Clearly understand the study and participate in it voluntarily; the informed consent should be signed in person or by legal guardian.
Chronic Stable Angina was confirmed by clinic over 3 months.
Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:
ultrasonic cardiogram disclosed that left ventricular ejection fraction ≥50 %.
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guizhou Provincial People's Hospital | Recruiting | Guiyang | Guizhou | 550001 | China |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| D001262 | Atenolol |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Atenolol | Drug | Not Provided |
|
|
| 12 weeks |
| Number of sublingual nitroglycerin consumption per week | 12 weeks |
| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
|
| The General Hospital of Shenyang Military | Recruiting | Shenyang | Liaoning | 110016 | China |
|
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |