EUCTR2020-004898-41-PL进行中（未招募）1 期
A multicentre, parallel group, randomised, double blind, placebo-controlled, phase II study evaluating the efficacy and safety of reperfusion thrombolytic therapy with intravenous recombinant tissue plasminogen activator (rtPA) for ischaemic stroke in patients on the non-vitamin K antagonist oral anticoagulant after reversing anticoagulant activity with the specific antidote - STROACT (STRoke on Oral AntiCoagulants for Thrombolysis)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •To be eligible for enrolment patient must meet all the following inclusion criteria:
- •1. Obtaining informed consent to participate in the trial prior to randomisation.
- •NOTE: Patients whose neurological deficit is severe enough to make it impossible to sign the consent form are allowed to give only their oral consent to participate in the study. However, this consent should be additionally certified by the signature of an independent witness who is neither a family member of the patient nor a person involved in the STROACT study. Patients with aphasia and/or other speech disorders may be included into the study if following neurological assessment of the recruiting stroke physician, they are able to understand all important information about the study.
- •2. Age >18 years.
- •3. Clinical diagnosis of acute ischemic stroke (sharply defined onset of first symptoms) resulting in a disabling neurological deficit.
- •4. Therapy with an oral anticoagulant that is the non-vitamin K antagonist oral anticoagulant (dabigatran, apixaban, or rivaroxaban) with laboratory confirmed therapeutic anti-IIa/anti-Xa activity measured as a plasma concentration > 50 ng/mL.
- •5. Administration of study intervention (intravenous thrombolysis with alteplase or placebo) should be possible to start within 4.5 hours from AIS symptoms onset or the last time the patient was seen without symptoms, as per investigator’s judgment.
- •NOTE: If patient had been randomised and there was an explicit clinical justification for delay in staring study intervention within 4.5h window, patient might continue in the study if rtPA (or rtPA placebo) could be administered within 6.0h from AIS 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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •To be eligible for enrolment patient must not meet any of the following exclusion criteria:
- •1. Occlusion of a large intracranial vessel in CT/MRI angiography (CTA/MRI), corresponding to the current acute neurological deficit, which is an indication for primary mechanical thrombectomy.
- •NOTE 1: If at the hospital admission the stroke severity assessment in NIHSS is = 6 points, then a large vessel occlusion (LVO) as an indication for primary mechanical thrombectomy (MT) must be excluded in CTA or standard angiography.
- •NOTE 2: Patients who qualify to the mechanical thrombectomy are not eligible for enrolment.
- •2. Significant disability prior to the current stroke event defined as >2 points on the modified Rankin Scale (mRS) and/or significant impairment of the cognitive function prior to AIS (documented in patient’s medical records).
- •3. Mild and rapidly improving neurological deficit with high probability of complete recovery defined as 1 point on the modified Rankin Scale.
- •4. Clinically severe stroke with >18 points in NIHSS.
- •5. Neuroimaging findings that might be responsible for acute neurological deficit (stroke mimics”) and/or are contraindications for standard thrombolytic treatment: such as intracranial and/or intracerebral bleeding, tumours, abscesses and other.
- •6. Treatment with the following anticoagulants:
- •a. Oral vitamin K antagonist (warfarin, acenocumarol),
- •b. Unfractionated heparin,
- •c. Low molecular weight heparin, or
- •d. Inhibitors of coagulation factor Xa or IIa other than dabigatran, rivaroxaban, or apixaban
- •7. Whole blood, and/or blood clotting factors (such as: prothrombin complex concentrate [PCC], recombinant factor VIIa [rVIIa], fresh frozen plasma [FFP]) administered within 7 days before study treatment initiation.
- •8. Anti-IIa/ Xa activity (which is considered to be directly proportional to the NOAC plasma concentration) is <50 ng/mL.
- •9. CT or MRI initial lesion volume >1/2 of the anatomical perfusion area of the middle cerebral artery (MCA), or anterior cerebral artery (ACA), or posterior cerebral artery (PCA).
- •10. Suspected subarachnoid haemorrhage based on specific symptomatology and/or physical examination (even if CT/MRI is normal).
- •11. Any history of subarachnoid or intracerebral haemorrhage, so not including previous (currently normal in neuroimaging) traumatic sub-or epidural hematomas > 6 months before the current acute stroke.
- •12. Any past (chronic) medical illnesses that significantly impairs patient’s functional status down to mRS 2 points or more (thus not only related to CNS pathologies and including cognitive impairment), and/or with a poor prognosis (e.g., neoplasms individually assessed to be of poor prognosis). NOTE: Patients after endovascular treatment of intracranial aneurysm may be considered for recruitment into the STROACT trial if the procedure was performed > 3 months prior to randomisation.
- •13. History of acute ischemic stroke treated with intravenous thrombolysis with rtPA or mechanical thrombectomy, or major surgery / trauma within 2 months before the current acute stroke.
- •14. Recent (within 10 days) traumatic external heart massage, obstetrical delivery, lumbar puncture, any puncture of a non-compressible blood vessel.
- •15. Severe trauma at the onset of acute ischemic stroke (e.g., skull fracture, long bone fracture, pelvic fracture).
- •16. Expected need for major surgery within 72 hours after randomisation (e.g., laparotomy, hip femoral/pelvic fracture surgery, carotid artery endarterectomy
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