A clinical trial to study effects of IvabradineÂ® when given in combination with AtenololÂ® for patients with Chronic Stable Angina.

Phase 4

Conditions: Chronic Stable Angina

Registration Number: CTRI/2009/091/000429

Lead Sponsor: Lupin Limited

Brief Summary: This is a phase IV, multi-centre, open label, comparative, parallel, randomized, observational study to compare the efficacy, safety and tolerability of IvabradineÂ® 5mg (titrated to 7.5 mg after Day 30) administered along with AtenololÂ® 50 mg versus AtenololÂ® 50 mg administered alone in patients with Chronic Stable Angina. A study will be conducted in 3 centres in India. Primary end-point of the study is change in Total Exercise Duration (TED) from baseline to end of treatment on Exercise Tolerance Test (ETT). Secondary end-points of the study are Change in other Exercise Tolerance Test (ETT) parameters including Time to Limiting Angina (TLA), Time to Onset of Angina (TOA), Time to 1-mm ST depression (TST) from Day 0 (Baseline) to Day 90 (End of Treatment), Change in frequency of anginal attacks,Need for anti-anginal rescue medications, Change in Heart Rate as measured in beats per min (bpm) from Day 0 (Baseline) to Day 90 (End of treatment).

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 230

Inclusion Criteria

•Male or Female patients > 18 years and ≤ 75 years of age.
•Patients with Chronic Effort Angina Pectoris for atleast 3 months prior to inclusion.
•Patients with Normal Sinus Rhythm on ECG at Screening.
•Patients undergoing treatment with AtenololÂ® or other beta-blocker agents for atleast 3 months.
•Patients with Positive Exercise Tolerance Test (ETT) at Screening.
•Patients who have signed Written Informed Consent.

Exclusion Criteria

•Male or Female patients < 18 years and > 75 years of age.•Resting Heart Rate of < 60 bpm as shown in ECG •Unstable Angina, Prinzmetal’s Angina or Microvascular Angina.•Recent acute myocardial infarction, coronary bypass surgery (less than 3 months before inclusion) or coronary angioplasty (less than 6 months before inclusion).
•Known high-grade left main coronary artery disease that has not been surgically bypassed or mechanically improved.•Patient who cannot perform Exercise Tolerance Test (ETT).
•ECG abnormalities that would confound ETT interpretation.•Clinically significant heart disease other than coronary artery disease.
•Congestive heart failure stage III or IV NYHA.•Symptomatic hypotension.•Uncontrolled hypertension (systolic blood pressure at rest > 180 mmHg or diastolic blood pressure at rest > 100 mmHg).
•Atrial fibrillation, flutter, pacemaker or cardioverter-defibrillator implantation.
•Patients with Hepatic disorders (ALT > 3 times normal value).
•Patients with Thyroid disorders.•Patients with kidney disorders, renal failure (Serum Creatinine level > 180 µmol/l).
•Patients with Anaemia (Haemoglobin < 10 g/l).
•Any treatment with unauthorized concomitant medication during the study.
•Treatment with Amiodarone® within 3 months prior to selection.
•Contraindication to Ivabradine®: Second and third degree atrioventricular block, or sick sinus syndrome.•Contraindication to Atenolol®: Second and third degree heart block, manifested heart failure, cardiogenic shock.•History of any serious infectious disease like Hepatitis B or C, HIV etc.
•History of severe psychiatric or behavioural disorders likely to interfere with the study.•History of serious abnormal drug reaction.
•History of any ophthalmic abnormality as found during screening.•Pregnant and lactating women.•Patients with other severe disease likely to interfere with the study in the investigator’s judgment.
•Use of investigational drug within 30 days of pre-selection, or concurrent therapy with an investigational drug(s).

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Total Exercise Duration (TED) on Exercise Tolerance Test (ETT) from	Baseline (Day 0) to End of treatment (Day 90)

Secondary Outcome Measures

Name	Time	Method
•Change in other Exercise Tolerance Test (ETT) parameters including Time to Limiting Angina (TLA), Time to Onset of Angina (TOA), Time to 1-mm ST depression (TST) from Baseline to Day 90 (End of treatment)•Change in Heart Rate as measured in beats per min (bpm) from Day 0 (Baseline) to Day 90 (End of treatment).•Change in frequency of anginal attacks•Change in need for anti-anginal rescue medication

Trial Locations

Locations (3): Cardiology Clinic
🇮🇳
Bangalore, KARNATAKA, India
Chandulal Chandrakar Memorial Hospital
🇮🇳
Road,, India
SGPGI-Lucknow
🇮🇳
Lucknow, UTTAR PRADESH, India
Cardiology Clinic
🇮🇳Bangalore, KARNATAKA, India
Dr VSPrakash
Principal investigator
080-23618860
drprakashvs@gmail.com