NCT04256473已完成2 期
Dual Thrombolytic Therapy With Mutant Pro-urokinase (M-pro-urokinase, HisproUK) and Low Dose Alteplase for Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Any intracranial hemorrhage according to the Heidelberg Bleeding Classification on MRI
研究概览
简要总结
Randomized controlled phase II trial to test the safety and preliminary efficacy of a dual thrombolytic treatment consisting of a small intravenous (IV) bolus of alteplase followed by IV infusion of mutant pro-urokinase against usual treatment with IV alteplase in patients presenting with ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of ischemic stroke;
- •A score of at least 1 on the NIH Stroke Scale;
- •CT ruling out intracranial hemorrhage;
- •Treatment possible within 4.5 hours from symptom onset or last seen well;
- •Meet the criteria for standard treatment for IV alteplase according to national guidelines27;
- •Age of 18 years or older;
- •Written informed consent (deferred).
排除标准
- •Candidate for endovascular thrombectomy (i.e., a proximal intracranial large artery occlusion on CTA);
- •Contra-indication for treatment with IV alteplase according to national guidelines27:
- •Arterial blood pressure exceeding 185/110 mmHg and not responding to treatment
- •Blood glucose less than 2.7 or over 22.2 mmol/L
- •Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
- •Head trauma in the previous 4 weeks
- •Major surgery or serious trauma in the previous 2 weeks
- •Gastrointestinal or urinary tract hemorrhage in the previous 2 weeks
- •Previous intracerebral hemorrhage
- •Use of anticoagulant with INR exceeding 1.7 or APTT exceeding 50 seconds
- •Known thrombocyte count less than 90 x 109 /L
- •Treatment with direct thrombin or factor X inhibitors, unless specific antidotum has been given, i.e. idarucizumab in case of dabigatran use.
- •Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2;
- •Known pregnancy or if pregnancy cannot be excluded, i.e. did not have intercourse for > 6 months and no clinical signs of pregnancy, adequate use of any contraceptive method (e.g. intrauterine devices) or sterilization of the subject herself.
- •Contra-indication for an MRI scan, i.e.:
- •an MRI incompatible pacemaker, ICD, pacing wires and loop records
- •metallic foreign bodies (e.g. intra-ocular)
- •prosthetic heart valves
- •blood vessel clips, coils or stents
- •an implanted electronic and/or magnetic implant or pump (e.g. neurostimulator)
- •cochlear implants
- •mechanical implants (implanted less than 6 weeks ago)
- •a copper intrauterine device
- •Current Participation in any medical or surgical therapeutic trial other than DUMAS.
研究组 & 干预措施
Intervention
Experimental
Bolus of IV alteplase (5 mg) followed by continuous infusion of HisproUK 40 mg/hr during 60 minutes.
Depending on results of interim analyses, the alternate dose may be revised to a lower dose (30mg/hr during 60 minutes) or a higher dose (50mg/hr during 60 minutes).
干预措施: mutant pro-urokinase (Drug)
Control
Active Comparator
Usual care with alteplase 0.9 mg/kg in 60 minutes
干预措施: Alteplase (Drug)
结局指标
主要结局
Any intracranial hemorrhage according to the Heidelberg Bleeding Classification on MRI
时间窗: 24-48 hours post-treatment
次要结局
- Death from any cause(Within 30 days)
- Infarct volume on MRI(at 24-48 hours)
- Score on the National Institutes of Health Stroke Scale (NIHSS)(at 24 hours and 5-7 days post-treatment)
- Score on the modified Rankin Scale (mRS)(at 30 days)
- Symptomatic intracranial hemorrhage (sICH) according to the Heidelberg Bleeding Classification(within 30 days)
- Change (pre-treatment vs. post-treatment) in abnormal perfusion volume based on TTP/MTT maps measured with CT perfusion at baseline and MRI(at 24-48 hours post treatment.)
- Secondary blood biomarkers of thrombolysis: d-dimer levels and fibrinogen levels.(1 hour post-treatment, after 3 hours, and after 24 hours post-treatment,)
- Major extracranial hemorrhage according to the ISTH criteria(within 24 hours of study drug administration)
研究者
Nadinda van der Ende
PI: Prof. Dr. DWJ Dippel and A. van der Lugt
Erasmus Medical Center
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Dual thrombolytic therapy with mutant pro-urokinase and low dose alteplase for ischemic strokeStroke, Ischemic stroke, Thrombolytic therapy, TreatmentNL-OMON29554Erasmus Medical Center, ROtterdam200
招募中
2 期
Dual thrombolytic therapy with mutant pro-urokinase (m-pro-urokinase, HisproUK) and low dose alteplase for ischemic strokebrain infarctionIschemic Stroke1000796310014523NL-OMON55848Erasmus MC, Universitair Medisch Centrum Rotterdam240
终止
早期 1 期
Research Into the Effect of a Clot-dissolving Agent and Its InhibitorAcute Ischemic StrokeNCT01694381TSI, LLC8
已完成
不适用
Dual IntraVenous Thrombolysis Approach (DIVA) in Patients With Medium-vessel-occlusion Strokes: a Retrospective StudyAcute Ischemic Stroke Due to Medium-vessel-occlusionNCT05809921Centre Hospitalier Sud Francilien294
Unknown
2 期
Anfibatide Treatment in STEMI PatientsST Segment Elevation Myocardial InfarctionNCT02495012Lee's Pharmaceutical Limited240