EUCTR2018-002620-17-ES进行中（未招募）1 期
A PHASE 4 RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA [ANDEXANET ALFA FOR INJECTION] IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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 medical proxy (or legally acceptable designee) has been adequately informed of the nature and risks of the study and has given written informed consent prior to Screening.
- •2. Age 18 years old or greater at the time of consent.
- •3. An acute intracranial bleeding episode, defined as any amount of blood acutely observed radiographically within the cranium. Patients may have extracranial bleeding (e.g., gastrointestinal, intraspinal) additionally, but the intracranial hemorrhage must be considered the primary bleed.
- •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 to meet this criterion).
- •5. Treatment with an oral FXa inhibitor (apixaban, rivaroxaban, or edoxaban) within 15 hours prior to randomization. If the time of last dose is unknown, the patient is not eligible for the study. If a patient is documented to have an anti-fXa activity > 100 ng/mL within 2 hours prior to consent, they may be enrolled irrespective of the time since last dose (as long as it is known).
- •6. Time from bleeding symptom onset < 12 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.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
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 are allowed (e.g., Burr holes for intracranial pressure monitoring, endoscopy, bronchoscopy, central lines—see Section 7.3 and Appendix F).
- •2. Glasgow Coma 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. Estimated intracerebral hematoma volume > 60 mL assessed by the baseline CT or MRI.
- •4. Any bleeding into the (intracranial) epidural space.
- •5. 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).
- •6. Expected survival of less than 1 month.
- •7. Recent history (within 2 weeks) of a diagnosed Thrombotic Event (TE) or clinically relevant symptoms of the following: Venous Thromboembolism (VTE: e.g., deep venous thrombosis, pulmonary embolism, cerebral venous thrombosis), myocardial
- •infarction, Disseminated Intravascular Coagulation (DIC), cerebral vascular accident, transient ischemic attack, acute coronary syndrome, or arterial systemic embolism within 2 weeks prior to Screening (see Appendix G for DIC scoring algorithm).
- •8. Acute decompensated heart failure or cardiogenic shock at the time of randomization (see Appendix H for cardiogenic shock definition).
- •9. Severe sepsis or septic shock at the time of randomization (see Appendix H for sepsis definition).
- •10. Pregnant or lactating.
- •11. 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®).
- •12. Past or planned use of andexanet.
- •13. Treatment with an investigational drug < 30 days prior to consent.
研究者
相似试验
进行中（未招募）
1 期
A phase 4 clinical trial to study the effect of andexanet alfa compared to the usual care with regards to stopping severe/life threatening bleeding in patients with bleeding inside the skull.Oral FXa inhibitor-treated patients with acute intracranial bleedingMedDRA version: 20.0Level: LLTClassification code 10075279Term: Anticoagulant reversal therapySystem Organ Class: 100000004865EUCTR2018-002620-17-ITPORTOLA PHARMACEUTICALS INC439
进行中（未招募）
1 期
A phase 4 clinical trial to study the effect of andexanet alfa compared to the usual care with regards to stopping severe/life threatening bleeding in patients with bleeding inside the skull.Oral FXa inhibitor-treated patients with acute intracranial bleeding.MedDRA version: 20.0Level: LLTClassification code 10075279Term: Anticoagulant reversal therapySystem Organ Class: 100000004865EUCTR2018-002620-17-FRPortola Pharmaceuticals, Inc440
已完成
4 期
A Phase 4 Randomized Clinical Trial of Andexanet Alfa [Andexanet Alfa for Injection] in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa InhibitorIntracranial Hemorrhagebrain bleeding (e.g. subdural, subarachnoidal)DRKS00017102Alexion Pharmaceutical, Inc.550
招募中
4 期
A phase 4 Randomized Clinical Trial of Andexanet Alfa [Andexanet Alfa for injection] in acute intracranial haemorrhage in patients receiving an oral factor Xa inhibitorNL-OMON49173Portola Pharmaceuticals Inc.12
进行中（未招募）
1 期
A clinical trial to study the effect of andexanet alfa compared to the usual care with regards to stopping severe/life threatening bleeding in patients with bleeding inside the skull.Oral FXa inhibitor-treated patients with acute intracranial bleeding.MedDRA version: 20.0Level: LLTClassification code 10075279Term: Anticoagulant reversal therapySystem Organ Class: 100000004865EUCTR2018-002620-17-ATAlexion Pharmaceuticals, Inc1,200