EUCTR2018-002620-17-AT进行中（未招募）1 期
A RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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. Written informed consent. Either the patient or his or her legally acceptable 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 soon as realistically possible after inclusion in Study 18-513 and in accordance with the Declaration of Helsinki, International Council for Harmonisation 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 of =0.5 mL to =60 mL acutely observed radiographically within the cerebrum. Patients may have extracerebral (e.g., subdural, subarachnoid, epidural) or extracranial (e.g., gastrointestinal, intraspinal) bleeding additionally, but the intracerebral hemorrhage must be considered the most clinically significant bleed at the time of enrollment.
- •4. Performance of a head CT or MRI scan demonstrating the intracranial 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]:
- •o=15 hours prior to randomization.
- •o > 15 hours prior to randomization or unknown time of last dose, only 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 repeat baseline imaging scan.)
- •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 drug.
- •8.Have a negative pregnancy test documented prior to enrollment (for females 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1010
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—Sections 7.2, 7.3 and Appendix G).
- •2. Glasgow Coma Scale (GCS) score < 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 non-neurologic 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 bleed).
- •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 H for cardiogenic shock definition).
- •8. Severe sepsis or septic shock at the time of randomization (see Appendix H 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
- •complex (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.
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