Evaluation of heart rate lowering effects with ivabradine in patients with angina in the hospital

Not Applicable

Completed

• Conditions: Coronary artery disease (CAD) and angina; Circulatory System

• Registration Number: ISRCTN14549448
• Lead Sponsor: Servier Maroc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-04-02
• Study Start: 2023-02-07
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

as per current SmPC
1. Patients 18 years and older
2. Female or male
3. Patients with documented stable coronary artery disease with or without left ventricular dysfunction (LVD); example: with angina, history of revascularization, history of myocardial infarction, or angiographic evidence of at least 70% stenosis of one of the major coronary arteries
4. Patient with stable angina diagnosed more than 6 months ago
5. HR resting >70 bpm
6. Patients inadequately controlled despite an optimal dose of beta-blockers

Exclusion Criteria

according to current SmPC
1. Known hypersensitivity to the active substance or any of the excipients
2. Resting heart rate of fewer than 70 beats per minute prior to treatment
3. Cardiogenic shock
4. Acute myocardial infarction
5. Severe hypotension (<90/50 mmHg)
6. Severe liver failure
7. Sick sinus syndrome
8. Atrial sinus block
9. Unstable or acute heart failure
10. Pacemaker-dependent patient (heart rate exclusively imposed by the pacemaker)
11. Unstable angina
12. Third-degree atrioventricular (AV) block
13. Combination with potent cytochrome P450 3A4 inhibitors, such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), protease inhibitors (nelfinavir, ritonavir) or nefazodone
14. Combination with verapamil or diltiazem, moderate CYP 3A4 inhibitors with bradycardic effects
15. Pregnancy, breastfeeding and women of childbearing age not using effective contraception

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. HR measured by electrocardiogram at baseline, after 1 month and after 4 months<br> 2. CCS grades determined using the Canadian Cardiovascular Society grading of angina pectoris system at baseline, after 1 month and after 4 months<br>

Secondary Outcome Measures

Name	Time	Method
Physician satisfaction assessed by rating the tolerability, efficacy, and effectiveness of ivabradine on a scale of 0 to 5 after 4 months of ivabradine treatment