Atrial Fibrillation MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Anthos Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent before the first study assessment is performed 2. Male and female patients = 55 years old 3. History of AF or atrial flutter with planned indefinite anticoagulation. Patients with newly diagnosed AF are eligible. 4. A CHA2DS2-VASc of =4 OR a CHA2DS2-VASc of =3 with at least 1 of the following: • Planned concomitant use of antiplatelet medication (e.g. aspirin and/or P2Y12 inhibitor) for the duration of the trial • CrCl =50 ml/min by the Cockcroft-Gault equation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: 1. Use of other investigational drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer 2. History of hypersensitivity to any of the study drugs (including rivaroxaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for rivaroxaban 3. Patients with an intracranial or intraocular bleed within the 3 months prior to screening 4. Clinically significant mitral stenosis (valve area 180 mm Hg or diastolic BP >100 mm Hg on repeated measurements at screening 10. Planned invasive procedure with potential for uncontrolled bleeding (e.g. major surgery) 11. Any stroke within 14 days before randomization or TIA within 3 days before randomization 12. A CrCl 1.5x the upper limit of normal (ULN) at the Screening Visit, if the patient is anticoagulant-naïve 16. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during their participation in the trial. Highly effective contraception methods include: • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment • Male sterilization of sexual partner (at least 6 months prior to screening). For female patients in the study, the vasectomized male partner should be the sole partner for that patient • Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. Hormonal contraceptive methods should not be used or encouraged if considered to be contraindicated. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of reported menopausal status or oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment with follicle stimulating hormone (FSH) is she considered not of child-bearing potential. 17.Sexually active males
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events;Secondary Objective: • To evaluate the effect of abelacimab relative to rivaroxaban on the rate of major bleeding events • To evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or minor bleeding events ;Primary end point(s): • Time to first event of composite of International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or CRNM bleeding events ;Timepoint(s) of evaluation of this end point: Time to first event | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to first event ISTH-defined major bleeding events Time to first event ISTH-defined major or minor bleeding events;Timepoint(s) of evaluation of this end point: Time to first event | — |
Countries
Canada, Czech Republic, Hungary, Korea, Republic of, Poland, Taiwan, United States
Contacts
Public ContactInformation Desk
Anthos Therapeutics, Inc.
Outcome results
None listed