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Active (not recruiting) Phase 3 NCT05757869

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

Phase 3 – large-scale trial before approval
Conditions: Atrial Fibrillation

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.
Who can participate
Inclusion Criteria: * Minimum age of 18 years * Medically stable and appropriate for chronic antithrombotic treatment * Atrial fibrillation eligible to receive anticoagulation * Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure Exclusion Criteria: * Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study * Any condition other than AF that requires chronic anticoagulation
Locations 37
Argentina (1)
Instituto de Investigaciones Clinicas Bahia Blanca
Bahía Blanca
Australia (1)
Flinders Medical Centre
Adelaide
Belgium (1)
Algemeen Stedelijk Ziekenhuis
Aalst
Brazil (1)
Hospital Felício Rocho
Belo Horizonte
Bulgaria (1)
MHAT Puls
Blagoevgrad
Canada (1)
The Governers of the University of Calgary
Calgery , Alberta
Chile (1)
Quantum Research
Puerto Varas
China (1)
Beijing Anzhen Hospital, Capital Medical University
Beijing
Croatia (1)
Zupanijska bolnica Cakovec
Čakovec
Czech Republic (1)
HUMANITAS spol. s r.o.
Bílovec
Denmark (1)
Aarhus University Hospital
Aarhus
Estonia (1)
Dr. Arvo Rosenthal LLC
Tallinn
France (1)
CHU Angers - Hopital Hotel Dieu
Angers
Greece (1)
Uni General Hospital of Alexandroupolis
Alexandroupoli
Hungary (1)
Lausmed Egeszsegugyi es Szolg. Kft.
Baja
India (1)
Jawaharlal Nehru Medical College and Hospital
Aligarh
Israel (1)
Haemek Medical Center
Afula
Italy (1)
Ospedale San Donato - ASL 8 Arezzo
Arezzo
Japan (1)
Kasugai Municipal Hospital
Aichi
Latvia (1)
Daugavpils Regional Hospital
Daugavpils
Lithuania (1)
Klinikiniai sprendimai JSC
Kaunas
Malaysia (1)
Hospital Sultanah Bahiyah
Alor Star
Netherlands (1)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
New Zealand (1)
North Shore Hospital
Auckland
Philippines (1)
Silang Specialists Medical Center
Cavite
Poland (1)
Wojewodzki Szpital Specjalistyczny
Biała Podlaska
Romania (1)
CMI Cardiologie Dr. Calin Pop
Baia Mare
Serbia (1)
Institute for Cardiovascular diseases Dedinje
Belgrade
Singapore (1)
National Heart Centre (NHC) Singapore
Singapore
Slovakia (1)
Alian s.r.o.
Bardejov
South Africa (1)
Tread Research
Cape Town
South Korea (1)
Hallym University Sacred Heart Hospital
Anyang-si
Spain (1)
Hosp Univ A Coruna
A Coruña
Taiwan (1)
Changhua Christian Hospital
Changhua
Turkey (1)
Afyon Kocatepe University Medical Faculty
Afyonkarahisar
United Kingdom (1)
Bristol Royal Infirmary
Bristol
United States (1)
Advanced Cardiovascular, LLC
Alexander City , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
11.04.2023
Completion date
31.10.2026
Registry ID
NCT05757869
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.