To Assess the Anti-anginal Safety and Efficacy of Ivabradine in Subjects With Stable，Symptomatic Chronic Angina
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|ClinicalTrials.gov Identifier: NCT02623569|
Recruitment Status : Unknown
Verified December 2015 by Xintong Pharmacy Company.
Recruitment status was: Recruiting
First Posted : December 7, 2015
Last Update Posted : December 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Angina Pectoris||Drug: Ivabradine Drug: Atenolol||Phase 2|
- Washout period：Chronic angina patients stop using medicine that affect heart rate. The patients undergoes ETT after 2-7 days and positive ETT into the treatment period(If not take similar medicine, patients can be carried out ETT directly)。
- Treatment period：Patients carried out ETT after therapy with Ivabradine(5mg,bid)/ Atenolol(12.5mg,bid) for 4 weeks.The dose adjust base on test result and heart rate, Ivabradine(5mg,bid)/Atenolol(12.5mg,bid) or Ivabradine(7.5mg,bid)/ Atenolol(25mg,bid) for 8 weeks and carried out ETT.
- security period：After the treatment period, all patients to take Atenolol 12.5mg/ 25mg bid 1 week.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||336 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
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.
Other Name: Not Provided
Active Comparator: Atenolol
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.
Other Name: Not Provided
- The primary efficacy endpoint is Change from total exercise duration in exercise tolerance test (ETT) [ Time Frame: Baseline and end of treatment (Week 12) . ]
- Time to angina in exercise tolerance test. [ Time Frame: 12 weeks ]
- Time to 1 mm ST-segment depression in exercise tolerance test [ Time Frame: 12 weeks ]
- Number of angina attacks in exercise tolerance test per week [ Time Frame: 12 weeks ]
- Number of sublingual nitroglycerin consumption per week [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623569
|Guizhou Provincial People's Hospital||Recruiting|
|Guiyang, Guizhou, China, 550001|
|Contact: Ping Zhang 0851-5623033 firstname.lastname@example.org|
|Zhongda Hospital Southeast University||Recruiting|
|Nanjing, Jiangsu, China, 210009|
|Contact: Genshan Ma 025-83272038 Magenshan@hotmail.com|
|The General Hospital of Shenyang Military||Recruiting|
|Shenyang, Liaoning, China, 110016|
|Contact: Yaling Han 024-28897309 email@example.com|