Prevention of Stroke in Intracerebral Haemorrhage Survivors with Atrial Fibrillation: Rationale and Design for PRESTIGE-AF Trial
Copyright policy )Prevention of Stroke in Intracerebral Haemorrhage Survivors with Atrial Fibrillation: Rationale and Design for PRESTIGE-AF Trial
AbstractAdequate secondary prevention in survivors of intracerebral hemorrhage (ICH) who also have atrial fibrillation (AF) is a long-standing clinical dilemma because these patients are at increased risk of recurrent ICH as well as of ischemic stroke. The efficacy and safety of oral anticoagulation, the standard preventive medication for ischemic stroke patients with AF, in ICH patients with AF are uncertain. PRESTIGE-AF is an international, phase 3b, multi-center, randomized, open, blinded end-point assessment (PROBE) clinical trial that compared the efficacy and safety of direct oral anticoagulants (DOACs) with no DOAC (either no antithrombotic treatment or any antiplatelet drug). Randomization occurred in a 1:1 ratio and stratification was based on ICH location and sex. The two co-primary binary endpoints included ischemic stroke and recurrent ICH which will be analyzed hierarchically according to the intention-to-treat principle. Secondary efficacy endpoints encompassed all-stroke and systemic embolism, all-cause and cardiovascular mortality, major adverse cardiac events, and net clinical benefit. Secondary safety endpoints included any major hemorrhage and intracranial hemorrhage. All outcome events were adjudicated by an independent committee. Results of PRESTIGE-AF are expected to support risk-adjusted secondary prevention in ICH survivors with AF and to inform clinical guideline recommendations.
- University of Seville Spain
- Danish Ramazzini Center Denmark
- University of Liverpool United Kingdom
- UNIVERSITE DE BORDEAUX France
- Institute of Mechanics and Engineering France
Malalties cerebrovasculars - Prevenció, ENFERMEDADES::afecciones patológicas, signos y síntomas::procesos patológicos::arritmias cardíacas::fibrilación atrial, Male, Other subheadings::Other subheadings::/therapeutic use, Malalties cerebrovasculars - Tractament, DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Intracranial Hemorrhages::Cerebral Hemorrhage, Otros calificadores::Otros calificadores::/uso terapéutico, Administration, Oral, Hemorràgia cerebral, direct oral anticoagulants, DISEASES::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Arrhythmias, Cardiac::Atrial Fibrillation, Anticoagulants (Medicina) - Ús terapèutic, Risk Factors, Recurrence, DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Stroke, COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos hematológicos::anticoagulantes, Atrial Fibrillation, ischemic stroke, Fibril·lació auricular, Secondary Prevention, CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Hematologic Agents::Anticoagulants, Humans, atrial fibrillation, Other subheadings::Other subheadings::Other subheadings::/prevention & control, Cerebral Hemorrhage, Aged, Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control, Anticoagulants, ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::hemorragias intracraneales::hemorragia cerebral, Middle Aged, intracerebral hemorrhage, Stroke, ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::accidente cerebrovascular, Treatment Outcome, randomized controlled trial, Female, Platelet Aggregation Inhibitors
Malalties cerebrovasculars - Prevenció, ENFERMEDADES::afecciones patológicas, signos y síntomas::procesos patológicos::arritmias cardíacas::fibrilación atrial, Male, Other subheadings::Other subheadings::/therapeutic use, Malalties cerebrovasculars - Tractament, DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Intracranial Hemorrhages::Cerebral Hemorrhage, Otros calificadores::Otros calificadores::/uso terapéutico, Administration, Oral, Hemorràgia cerebral, direct oral anticoagulants, DISEASES::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Arrhythmias, Cardiac::Atrial Fibrillation, Anticoagulants (Medicina) - Ús terapèutic, Risk Factors, Recurrence, DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Stroke, COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos hematológicos::anticoagulantes, Atrial Fibrillation, ischemic stroke, Fibril·lació auricular, Secondary Prevention, CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Hematologic Agents::Anticoagulants, Humans, atrial fibrillation, Other subheadings::Other subheadings::Other subheadings::/prevention & control, Cerebral Hemorrhage, Aged, Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control, Anticoagulants, ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::hemorragias intracraneales::hemorragia cerebral, Middle Aged, intracerebral hemorrhage, Stroke, ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::accidente cerebrovascular, Treatment Outcome, randomized controlled trial, Female, Platelet Aggregation Inhibitors
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