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Trial registered on ANZCTR


Registration number
ACTRN12613000354785
Ethics application status
Approved
Date submitted
26/03/2013
Date registered
3/04/2013
Date last updated
4/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and Safety Study of the Ivabradine Hydrochloride Tablets versus Atenolol Tablets in Patients With Chronic Stable Angina Pectoris.
Scientific title
Efficacy and Safety Study of the Ivabradine Hydrochloride Tablets versus Atenolol Tablets in Patients With Chronic Stable Angina Pectoris.
Secondary ID [1] 282191 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 288703 0
Condition category
Condition code
Cardiovascular 289052 289052 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with chronic stable angina receive Ivabradine Hydrochloride tablets 5 mg twice a day for 4 weeks,and then if resting heart rate is greater than 80bpm,participants take 7.5mg twice a day for 8 weeks; if resting heart rate is less than or equal to 80bpm,participants take 5mg twice a day for 8 weeks.
The subjects had only one drug number.Investigators should keep an account of the actual dose,and record the grant and recovery of drugs.
Intervention code [1] 286798 0
Treatment: Drugs
Comparator / control treatment
Patients with chronic stable angina receive Atenolol tablets 12.5 mg twice a day for 4 weeks,and then if resting heart rate is greater than 80bpm,participants take 25mg twice a day for 8 weeks; if resting heart rate is less than or equal to 80bpm,participants take 12.5mg twice a day for 8 weeks.
The subjects had only one drug number.Investigators should keep an account of the actual dose,and record the grant and recovery of drugs.
Control group
Active

Outcomes
Primary outcome [1] 289190 0
Relative change in the Total Exercise Duration during exercise tolerance tests (ETT)
Timepoint [1] 289190 0
Baseline, and at 12 weeks after intervention commencement
Secondary outcome [1] 301986 0
Relative change in the Time to angina onset during ETT
Timepoint [1] 301986 0
Baseline, and at 12 weeks after intervention commencement
Secondary outcome [2] 301987 0
Relative change in the Time to 1mm ST-segment depression during ETT.
This outcome is assessed by electrocardiogram.
Timepoint [2] 301987 0
Baseline, and at 12 weeks after intervention commencement
Secondary outcome [3] 301989 0
Relative change in the Time to limiting angina during ETT
Timepoint [3] 301989 0
Baseline, and at 12 weeks after intervention commencement
Secondary outcome [4] 301990 0
Relative change in the Rate-pressure product during ETT.
This outcome is assessed by electrocardiogram.
Timepoint [4] 301990 0
Baseline, and at 12 weeks after intervention commencement
Secondary outcome [5] 301991 0
Relative change in the mean number of angina attacks per over a 12-week treatment period.
This outcome is assessed by a patient diary.
Timepoint [5] 301991 0
Baseline, and at 12 weeks after intervention commencement
Secondary outcome [6] 301992 0
Relative change in the mean consumption of short acting nitrates per week over a 12-week treatment.
This outcome is assessed by a patient diary.
Timepoint [6] 301992 0
Baseline, and at 12 weeks after intervention commencement
Secondary outcome [7] 301993 0
Heart rate (HR, bpm)
This outcome is assessed by a heart rate monitor worn for a period of 24 hours.
Timepoint [7] 301993 0
Baseline, and at 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
1. Informed Consent
2. A history of stable effort angina for greater than or equal to 3 months prior to study
entry
3. Evidence of coronary artery disease(CAD) manifested by greater than or equal to 1 of five criteria:
(1)Coronary angioplasty greater than or equal to 6 months or bypass surgery greater than or equal to 6 months before entry
(2)Coronary angiogram showing greater than or equal to 1 diameter stenosis greater than or equal to 50%,or scintigraphic/echocardiographic evidence of exercise-induced reversible myocardial ischaemia
(3) coronary disease(including myocardial infarction) greater than or equal to 3 months before study entry
4. LVEF greater than or equal to 50%
5. Ischemic ECG changes:1 mm horizontal or downsloping ST-segment depression (measured 0.08s after the J-point on greater than or equal to 3 consecutive complexes) between 3 and 12 min of initiation
6. Positive ETT should be manifested

Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant heart disease other than CAD
2. Coronary angioplasty<6 months or bypass surgery <6 months
3. Myocardial infarction/unstable angina within 3 months
4. Known high-grade left main CAD
5. Congestive heart failure stage III/IV NYHA
6. Resting HR<60bpm
7. Arhythmia:e.g,atrial fibrillation/flutter or indwelling pacemaker, 2 degrees and 3 degrees atrioventricular block
8. Inability to perform ETT
9. Symptomatic hypotension or uncontrolled hypertension [resting systolic blood pressure (SBP)>180 mmHg or diastolic blood pressure (DBP)>100 mmHg]
10. FBG greater than or equal to 11.1 mmol/L,or fasting GLU greater than or equal to 13.6 mmol/L
11. Anemia(Male:hemoglobin less than or equal to120 g/L;Female:hemoglobin less than or equal to110 g/L)
12. Cancer
13. Aids
14. Drug or Alcohol abuse
15. Psychosis
16. Recent treatment with amiodarone (<3 months) or bepridil (<7 days)
17. ALT>2 times normal value
18. Serum creatinine>180 mmol/L
19. Allergic to test drugs
20. Pregnancy or breastfeeding


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4955 0
China
State/province [1] 4955 0

Funding & Sponsors
Funding source category [1] 286955 0
Commercial sector/Industry
Name [1] 286955 0
Jiangsu Hengrui Medicine Co., Ltd.
Address [1] 286955 0
No.7 Kunlunshan Road, Lianyungang Eco & Tech Development Zone, Jiangsu Province
Postcode:222047
Country [1] 286955 0
China
Primary sponsor type
Hospital
Name
Fu Wai Hospital
Address
No. 167 North Lishi Road, Xicheng District, Beijing
Postcode: 100037
Country
China
Secondary sponsor category [1] 285742 0
None
Name [1] 285742 0
Address [1] 285742 0
Country [1] 285742 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
1. To evaluate the effectiveness,safety and tolerance of Ivabradine Hydrochloride in patients with chronic stable angina
2. To demonstrate that Ivabradine Hydrochloride non-inferiority to Atenolol with chronic stable angina
3. Chinese patinets with chronic stable angina can have more choices of antianginal drugs,especially to that have an allergy or intolerance to beta receptor blockers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38762 0
Prof Youhong Jia
Address 38762 0
Duty:Vice director of center of clinical pharmacology(standing) of Fu Wai Hospital,Deputy director of the four ward of Department of Internal Medicine of Fu Wai Hospital.Engaged in clinical department of cardiology and clinical research on new drugs of cardiovascular disease.
Address:No. 167 North Lishi Road, Xicheng District, Beijing
Postcode:100037
Country 38762 0
China
Phone 38762 0
+86 010 68331753
Fax 38762 0
Email 38762 0
yhjia2002@gmail.com
Contact person for public queries
Name 38763 0
Prof Youhong Jia
Address 38763 0
Duty:Vice director of center of clinical pharmacology(standing) of Fu Wai Hospital,Deputy director of the four ward of Department of Internal Medicine of Fu Wai Hospital.Engaged in clinical department of cardiology and clinical research on new drugs of cardiovascular disease.
Address:No. 167 North Lishi Road, Xicheng District, Beijing
Postcode:100037
Country 38763 0
China
Phone 38763 0
+86 010 68331753
Fax 38763 0
Email 38763 0
yhjia2002@gmail.com
Contact person for scientific queries
Name 38764 0
Prof Youhong Jia
Address 38764 0
Duty:Vice director of center of clinical pharmacology(standing) of Fu Wai Hospital,Deputy director of the four ward of Department of Internal Medicine of Fu Wai Hospital.Engaged in clinical department of cardiology and clinical research on new drugs of cardiovascular disease.
Address:No. 167 North Lishi Road, Xicheng District, Beijing
Postcode:100037
Country 38764 0
China
Phone 38764 0
+86 010 68331753
Fax 38764 0
Email 38764 0
yhjia2002@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary