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临床试验/NL-OMON54049
NL-OMON54049尚未招募4 期

A Randomized Clinical Trial of Andexanet Alfa in acute intracranial haemorrhage in patients receiving an oral factor Xa inhibitor - ANNEXA-I

Alexion Pharmaceuticals, Inc.0 个研究点目标入组 45 人开始时间: 待定最近更新:
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试验速览

阶段
4 期
状态
尚未招募
入组人数
45
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

入排标准

年龄范围
18 至 99（—）

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
  • •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 care. Note: Patients enrolled in this manner
  • •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.

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,
  • •ronchoscopy, 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

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