Vortosiran in Atrial Fibrillation

Ki vehet részt

• Adult male and female participants, age >/=45 years
• Documented diagnosis of non-valvular AF within 12 months of signing the informed consent (paroxysmal, persistent, or permanent) confirmed by ECG evidence (12-lead or other physician-confirmed electronic recording) and currently receiving continuous treatment with a DOAC for stroke prevention for at least the past 3 months
• Capable of giving signed informed consent. Written informed consent must be obtained before any trial procedure is initiated
• Postmenopausal women are eligible without additional contraceptive measures. Postmenopausal status is defined as:; Age >/=55 years with >/=12 months of spontaneous amenorrhea, or; Age <55 years with >/=12 months of spontaneous amenorrhea and follicle-stimulating hormone in the postmenopausal range, or surgical menopause (bilateral oophorectomy, with or without hysterectomy) documented in the medical history
• Women of childbearing potential must agree to use highly effective contraception for the duration of trial treatment and for the specified post-treatment period

Ki nem vehet részt

• Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral haemorrhage at any time in the absence of antithrombotic treatment
• Any stroke within 14 days before randomisation or a transient ischemic attack within 3 days before randomisation
• Any history of non-traumatic intracranial haemorrhage when not under treatment with an anticoagulant
• Anticipated need for chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs): Patients with chronic NSAID use, defined as systemic NSAID therapy on >/=3 days per week for at least 4 consecutive weeks prior to screening, are excluded
• Treated with a vitamin K antagonist within 3 months prior to screening
• Known current alcohol and / or illicit drug abuse that may interfere with the participant's safety and / or compliance at the discretion of the Investigator
• Previous (within 30 days or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical trial with investigational medicinal product(s) or device(s). Registries and observational studies are allowed
• AF due to a reversible cause (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism, alcohol use), participants in sinus rhythm after successful ablation or planned for cardioversion or ablation during trial conduct
• Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or trans vascular) during the course of the trial
• Patients with a medical condition other than non-valvular AF for which chronic anticoagulation is indicated
• History of or planned left atrial appendage closure or left atrial appendage removal
• Uncontrolled hypertension (systolic blood pressure >/= 160 mmHg or diastolic blood pressure >/=100 mmHg) at randomization
• Major surgery during the last 30 days or planned major surgery or intervention with potential for uncontrolled bleeding within the trial period (e.g., carotid endarterectomy, coronary artery bypass grafting)
• Known allergy, intolerance, or hypersensitivity to any of the trial interventions
• Patients with a diagnosis of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) at screening
• Any other condition or therapy that would make the participant unsuitable for the trial
• Active bleeding, known bleeding disorder, or known anaemia that requires treatment or capillary Hgb <100 g/L
• Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or hepatic insufficiency classified as Child-Pugh B or C, or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2.5 x the upper limit of normal, measured between screening and randomisation
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 from the local lab, determined between screening and randomization
• Known presence of an atrial myxoma or left ventricular thrombus
• Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post-treatment period are not eligible
• Any contraindication for the use of an anticoagulant or listed in the local labelling for apixaban
• Male participants who are not willing to use condoms when sexually active with a woman of childbearing potential who is not using highly effective contraception