ESSENTIEL Hospital: observation of exclusive heart rate reduction effects with ivabradine in angina patients in a hospital setting

Servier Maroc0 个研究点目标入组 125 人开始时间: 2023年2月7日最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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

•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

发起方

Servier Maroc