EUCTR2020-004507-13-PL进行中（未招募）1 期
A Multicenter, Randomized, Active-Controlled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab (MAA868) Compared with Open-Label Rivaroxaban in Patients with Atrial Fibrillation - AZALEA
Anthos Therapeutics0 个研究点目标入组 1,200 人开始时间: 2021年1月18日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •Extension period inclusion criteria:
- •Patients eligible for inclusion in the extension period must fulfill all the
- •following criteria:
- •1. Ongoing study treatment for the randomized part of the trial at the
- •2. Able to provide written informed consent to enter the extension
- •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
排除标准
- •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 <1.5 cm2)
- •5. Mechanical heart valve or other indication for anticoagulation therapy
- •other than atrial fibrillation (e.g., venous thromboembolism)
- •6. Known presence of an atrial myxoma or left ventricular thrombus
- •7. History of left atrial appendage closure or removal
- •8. Active endocarditis
- •9. Systolic BP >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 <15 mL/min or on dialysis at the time of Screening
- •13. Platelet count =70,000/mm3 at the Screening Visit
- •14. Hemoglobin <8 g/dL at the Screening Visit
- •15. aPTT or PT >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 agree to use highly effective methods of contraception during their participation in the trial and for at least 10 weeks after the last dose of abelacimab for
- •women randomized to abelacimab. Highly effective contraception methods
- •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 t
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