A RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR - ANNEXa-I

Alexion Pharmaceuticals, Inc.0 个研究点目标入组 1,200 人开始时间: 2019年4月30日最近更新: 2023年9月26日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Alexion Pharmaceuticals, Inc.
入组人数: 1,200

研究概览入排标准研究者记录与标识符相似试验

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. Written informed consent. Either the patient or his or her legally
•authorized representative (LAR) if permissible by local or regional laws
•and regulations has been adequately informed of the nature and risks of
•the study and has given written informed consent prior to Screening.
•-Deferred consent procedure is allowed where approved by local ethics
•committees. In cases of deferred consent, the time of the study
•physician's documented decision to include the patient into the study
•will serve as time of consent with respect to protocol-specific
•procedures.
•-In all cases where the patient does not sign informed consent prior to
•study entry, informed consent from the patient (or LAR) will be obtained
•as realistically possible after inclusion in the study 18-513 and in
•accordance with
•the Declaration of Helsinki, International Council for Harmonization of
•Technical Requirements for Pharmaceuticals for Human Use (ICH), Good
•Clinical Practice (GCP), the EU General Data Protection Regulation (GDPR) and national and local regulations.
•2. Age =18 years old at the time of consent.
•3. An acute intracranial bleeding episode, defined as an estimated blood
•volume =0.5 mL to =60 mL acutely observed radiographically within the
•cranium. Patients may have extracerebral (e.g., subdural, subarachnoid,
•epidural) or extracranial bleeding (e.g., gastrointestinal, intraspinal)
•additionally, but the intracebral hemorrhage must be considered the
•significant bleed at the time of enrollment.
•4. Performance of a head CT or MRI scan demonstrating the
•intracerebral bleeding within 2 hours prior to randomization (the
•baseline scan may be repeated only once to meet this criterion).
•5. Treatment with an oral FXa inhibitor (apixaban [last dose 2.5 mg or
•greater], rivaroxaban [last dose 10 mg or greater], or edoxaban [last
•dose 30 mg or greater]):
•-=15 hours prior to randomization.
•-> 15 hours prior to randomization or unknown time of last dose, if
•1) the local anti-fXa activity > 100 ng/mL (for direct fXa inhibitors (apixaban, rivaroxaban or edoxaban) and
•2) the local anti-fXa activity level is obtained within 2 hours prior to consent, performed as per standard of care.
•Note: Patients enrolled in this manner should
•receive a high andexanet dosing regimen.
•6. Time from bleeding symptom onset < 6 hours prior to the baseline
•imaging scan. Time of trauma (if applicable) or time last seen normal
•may be used as surrogates for time of symptom onset.(If the baseline
•scan is repeated to meet Inclusion Criterion #4, the time from bleeding
•symptom onset must be < 6 hours prior to the repeated baseline imaging
•7. Female patients of childbearing potential and male patients with
•female partners of childbearing potential must follow protocol-specified
•guidance for avoiding pregnancy for 30 days after the last dose of study
•8.Have a negative pregnancy test documented prior to enrollment (for
•women of childbearing potential).
•9. NIHSS score = 35 at the time of consent.
•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 190
另有 2 项未显示

排除标准

•1. Planned surgery, including Burr holes for hematoma drainage, within
•12 hours after randomization. Minimally invasive surgery/procedures
•not directly related to the treatment of intracranial bleeding and that are
•not expected to significantly affect haematoma volume are allowed (e.g.,
•Burr holes for intracranial pressure monitoring, endoscopy,
•bronchoscopy, central lines—see Section 7.2 and 7.3 and Appendix G).
•2. Glasgow Coma score (GCS) < 7 at the time of consent. If a patient is
•intubated and/or sedated at the time of consent, they may be enrolled if
•it can be documented that they were intubated/sedated for nonneurologic
•reasons within 2 hours prior to consent.
•3. Purposefully left blank to align with the programmed database.
•4. Anticipation that the baseline and follow up brain scans will not be
•able to use the same imaging modalities (i.e., patients with a baseline CT
•scan should have a CT scan in follow up; similarly for MRI).
•5. Expected survival of less than 1 month (not related to intracranial
•6. Recent history (within 2 weeks) of a diagnosed TE or clinically
•relevant symptoms of the following: -Venous Thromboembolism (VTE:
•e.g., deep venous thrombosis, pulmonary embolism [PE], cerebral
•venous thrombosis), myocardial infarction [MI], Disseminated
•Intravascular Coagulation (DIC), cerebral vascular accident, transient
•ischemic attack [TIA], acute coronary syndrome, or arterial systemic
•embolism (see Appendix H for DIC scoring algorithm).
•7. Acute decompensated heart failure or cardiogenic shock at the time of
•randomization (see Appendix A for cardiogenic shock definition).
•8. Severe sepsis or septic shock at the time of randomization (see
•Appendix A for sepsis definition).
•9. The patient is a pregnant or lactating female.
•10. Receipt of any of the following drugs or blood products within 7 days
•prior to consent:
•a. Vitamin K Antagonist (VKA) (e.g., warfarin).
•b. Dabigatran.
•c. Prothrombin Complex Concentrate products (PCC, e.g., Kcentra®) or
•recombinant
•factor VIIa (rfVIIa) (e.g., NovoSeven®), or anti-inhibitor coagulant
•(e.g., FEIBA®), FFP and whole blood.
•11. Past use of andexanet (or planned use of commercial andexanet).
•12. Treatment with an investigational drug < 30 days prior to consent.
•13. Any tumor-related bleeding.
•14. Known hypersensitivity to any component of andexanet.

研究者

发起方

Alexion Pharmaceuticals, Inc.

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