NL-OMON49173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 inhibitor - ANNEXA-I
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 12
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 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.
- •In the Netherlands, deferred consent procedure is allowed. In cases of deferred
- •the time of the study physician*s documented decision to include the patient
- •study will serve as *time of consent* with respect to protocol-specific
- •procedures.
- •In all cases where the patient does not sign informed consent for prior to
- •study entry,
- •informed consent from the patient will be obtained as soon as realistically
- •possible after
- •inclusion in the trial and in accordance with the Declaration of Helsinki,
- •ICH-GCP, the
- •Data Protection Directive (Directive 95/46/EC) and national and local
- •regulations.
- •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.
排除标准
- •If a patient meets any of the following criteria, he/she is not eligible to
- •participate in this trial.
- •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
- •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
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
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
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.EUCTR2018-002620-17-ESPortola Pharmaceuticals, Inc440
尚未招募
4 期
A Randomized Clinical Trial of Andexanet Alfa in acute intracranial haemorrhage in patients receiving an oral factor Xa inhibitorNL-OMON54049Alexion Pharmaceuticals, Inc.45