脑取栓术 2 的化学优化（选择 2）。 (CHOICE2)
2026年9月15日 更新者：Angel Chamorro, M.D., Ph.D.、Hospital Clinic of Barcelona
机械血栓切除术治疗急性卒中患者脑血栓切除术的化学优化 2（选择 2 试验）
Multi-center, randomized, parallel-group, superiority study to compare the efficacy of adjunct intra-arterial rt-PA versus not adjunct intra-arterial rt-PA in the improvement of the efficacy of mechanical thrombectomy in patients with large vessel occlusion acute ischemic stroke.
研究概览
研究类型
介入性
注册 (实际的)
440
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Spain
-
A Coruña、Spain、西班牙
- Hospital Universitario de A Coruña
-
Alicante、Spain、西班牙
- Hospital Universitario Dr. Balmis
-
Badalona、Spain、西班牙
- Hospital Germans Trías i Pujol
-
Barcelona、Spain、西班牙、08014
- Hospital Clinic Barcelona
-
Barcelona、Spain、西班牙
- Hospital de la Santa Creu i Sant Pau
-
Bilbao、Spain、西班牙
- Hospital Universitario de Cruces
-
Girona、Spain、西班牙
- Hospital Josep Trueta
-
Murcia、Spain、西班牙
- Hospital Universitario Virgen de la Arrixaca
-
Oviedo、Spain、西班牙
- Hospital Universitario Central de Asturias
-
Palma de Mallorca、Spain、西班牙
- Hospital Universitario Son Espases
-
Pamplona、Spain、西班牙
- Hospital Universitario de Navarra
-
San Sebastián、Spain、西班牙
- Hospital Universitario de Donostia
-
Valencia、Spain、西班牙
- Hospital Univesitario y Politénico La Fe
-
Valladolid、Spain、西班牙
- Hospital Universitario de Valladolid
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with symptomatic large vessel occlusion (LVO) in the anterior circulation (ICA, ACA or MCA) treated with MT resulting in a mTICI score 2b/3 at end of the procedure. Patients with a mTICI score 2b/3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study.
- Estimated delay to onset of rescue intraarterial rt-PA administration <24 hours from symptom onset, defined as the point in time the patient was last seen well.
- No significant pre-stroke functional disability (modified Rankin scale 0-1), or mRS >1 that according to the investigator is not related to neurological disease (i.e., amputation, blindness)
- Age ≥18
- ASPECTS >6 on non-contrast CT (NCCT) scan if symptoms lasting <4.5 hours of last seen well. In patients with >4.5h of last seen well, a CT-perfusion (Flow maps) or MRI-perfusion should be considered instead of NCCT, especially if >9h have elapsed, or in seriously ill patients (i.e., NIHSS>17). Nonetheless, if a perfusion study is not available, NCCT can still be used as long as it is confirmed without a doubt that the ASPECTS is > 6.
- Informed consent, obtained from patient or acceptable patient surrogate, or Differed Informed Consent (DIC) to avoid any delay in the initiation of the mechanical thrombectomy and the i.a thrombolysis. The DIC will be signed by the patient or acceptable patient surrogate at any time after the tPA treatment is started.
Exclusion Criteria:
- NIHSS score on admission >25
- Contraindication to IV t-PA as per local national guidelines (except time to therapy)
- Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h
- Need of more than 3 passes (per vessel) or more than a total of 5 passes (in more than one vessel) to complete the endovascular procedure
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- Current participation in another investigation drug or device treatment study
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- Known coagulopathy, INR > 1.7
- Platelets < 50,000
- Renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] < 30
- Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
- Any hemorrhage on CT/MRI
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
- Suspicion of aortic dissection
- Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
- History of life-threatening allergy (more than rash) to contrast medium
- SBP >185 mmHg or DBP >110 mmHg refractory to treatment
- Serious, advanced, terminal illness with anticipated life expectancy < 6 months
- Pre-existing neurological or psychiatric disease that would confound evaluation
- Presumed vasculitis or septic embolization
- Unlikely to be available for 90-day follow-up (i.e., no fixed home address, visitor from overseas)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intraarterial alteplase
All the patients will be given a 15 minutes IA infusion of alteplase (Actylise®) at a drug concentration of 1.0 mg/ml. At 15 minutes of IA treatment onset, the infusion will be stopped and the angiographic score assessed. Study drug will be prepared according to the following steps: 1/ Dilute 2 vials of 10 mgs (rt-PA) in 20 cc of sterile water for injection (SWI), to attain a 20 ml solution at a concentration of 1mg/ml; 2. Calculate the volume of cc of infusion and therefore the total dose as per the formula: (Patient's weight in Kgs multiplied by 0.225). A patient of 89 Kgs or more will receive 20.0 cc of infusion for 15 min, totaling a dose of 20.0 mg of rt-PA. |
See arm/group descriptions.
其他名称：
|
|
无干预：No intervention
Patients allocated to this arm will receive a similar care to patients allocated to IA alteplase except the thrombolytic |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Modified Rankin Scale at day 90
大体时间：90 days post treatment
|
Proportion of patients with Modified Rankin Scale 0 or 1 at day 90 +/- 15d |
90 days post treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Microvascular hypoperfusion on follow-up brain CTP
大体时间：36±24hours post treatment
|
Proportion of patients with abnormal microvascular hypoperfusion on CT Perfusion |
36±24hours post treatment
|
|
Volume of hypoperfusion on brain CTP
大体时间：at 36h±24h post treatment
|
Volume of hypoperfusion on brain CTP |
at 36h±24h post treatment
|
|
Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP
大体时间：36±24hours post treatment
|
Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP at 36±24hours post MT. |
36±24hours post treatment
|
|
Barthel Scale score
大体时间：day 90 post treatment
|
Barthel Scale score of 95 to 100, (min value 0, max value 100, higher score better outcome) |
day 90 post treatment
|
|
EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L)
大体时间：day 90 post treatment
|
Quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L) The score has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
day 90 post treatment
|
|
Shift analysis of the modified Rankin Scale (mRS)
大体时间：day 90 post treatment
|
Shift analysis of the modified Rankin Scale (mRS), at day 90 (min value 0, max value 6, higher score worse outcome) |
day 90 post treatment
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SAFETY OUTCOME: Mortality at 90 days
大体时间：Day 90
|
Mortality at 90 days |
Day 90
|
|
SAFETY OUTCOME: symptomatic intracerebral hemorrahge (sICH ) rate at 24 hours.
大体时间：24hours post MT
|
Symptomatic ICH will be classified as per the European Cooperative Acute Stroke Study (ECASS) 3 criteria |
24hours post MT
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Juan F Arenillas, MD、Hospital Universitario de Valladolid
- 首席研究员：María del Mar Freijo, MD、Hospital Universitario de Cruces
- 首席研究员：Pedro Vega, MD、Hospital Universitario Central de Asturias
- 学习椅：Angel Chamorro, MD, PhD、Comprehensive Stroke Center, Hospital Clinic Barcelona
- 首席研究员：Arturo Renú, MD, PhD、Comprehensive Stroke Center, Hospital Clinic Barcelona
- 首席研究员：Patricia de la Riva, MD、Hospital Donostia
- 首席研究员：M Dolores Fernándes, MD、Hospital Universitario de A Coruña
- 首席研究员：Lluis Morales, MD、Hospital Universitario La Fe de Valencia
- 首席研究员：Laura Dorado, MD、Hospital Germans Trias i Pujol de Badalona
- 首席研究员：Mikel Terceño, MD、Hospital Universitario Dr. Josep Trueta de Girona
- 首席研究员：Ana Morales, MD、Hospital Universitario Virgen de Arrixaca Murcia
- 首席研究员：Maria Herrera, MD、Hospital of Navarra
- 首席研究员：Raquel Delgado, MD、Hospital Universitario Son Espases Mallorca
- 首席研究员：Nicolás López, MD、Hospital Universitario Dr. Balmis Alicante
- 首席研究员：Pol Camps, MD、Hospital Universitario de la Santa Creu i Sant Pau Barcelona
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.
- Chamorro A, Blasco J, Lopez A, Amaro S, Roman LS, Llull L, Renu A, Rudilosso S, Laredo C, Obach V, Urra X, Planas AM, Leira EC, Macho J. Complete reperfusion is required for maximal benefits of mechanical thrombectomy in stroke patients. Sci Rep. 2017 Sep 14;7(1):11636. doi: 10.1038/s41598-017-11946-y.
- Davalos A, Cobo E, Molina CA, Chamorro A, de Miquel MA, Roman LS, Serena J, Lopez-Cancio E, Ribo M, Millan M, Urra X, Cardona P, Tomasello A, Castano C, Blasco J, Aja L, Rubiera M, Gomis M, Renu A, Lara B, Marti-Fabregas J, Jankowitz B, Cerda N, Jovin TG; REVASCAT Trial Investigators. Safety and efficacy of thrombectomy in acute ischaemic stroke (REVASCAT): 1-year follow-up of a randomised open-label trial. Lancet Neurol. 2017 May;16(5):369-376. doi: 10.1016/S1474-4422(17)30047-9. Epub 2017 Mar 16.
- Renu A, Blasco J, Millan M, Marti-Fabregas J, Cardona P, Oleaga L, Macho J, Molina C, Roquer J, Amaro S, Davalos A, Zarco F, Laredo C, Tomasello A, Guimaraens L, Barranco R, Castano C, Vivas E, Ramos A, Lopez-Rueda A, Urra X, Muchada M, Cuadrado-Godia E, Camps-Renom P, Roman LS, Rios J, Leira EC, Jovin T, Torres F, Chamorro A; CHOICE Investigators. The Chemical Optimization of Cerebral Embolectomy trial: Study protocol. Int J Stroke. 2021 Jan;16(1):110-116. doi: 10.1177/1747493019895656. Epub 2019 Dec 18.
- Renu A, Millan M, San Roman L, Blasco J, Marti-Fabregas J, Terceno M, Amaro S, Serena J, Urra X, Laredo C, Barranco R, Camps-Renom P, Zarco F, Oleaga L, Cardona P, Castano C, Macho J, Cuadrado-Godia E, Vivas E, Lopez-Rueda A, Guimaraens L, Ramos-Pachon A, Roquer J, Muchada M, Tomasello A, Davalos A, Torres F, Chamorro A; CHOICE Investigators. Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial. JAMA. 2022 Mar 1;327(9):826-835. doi: 10.1001/jama.2022.1645.
- Laredo C, Rodriguez A, Oleaga L, Hernandez-Perez M, Renu A, Puig J, Roman LS, Planas AM, Urra X, Chamorro A. Adjunct Thrombolysis Enhances Brain Reperfusion following Successful Thrombectomy. Ann Neurol. 2022 Nov;92(5):860-870. doi: 10.1002/ana.26474. Epub 2022 Aug 23.
- Chamorro A, Torres F. Intra-arterial Alteplase vs Placebo After Successful Thrombectomy and Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke-Reply. JAMA. 2022 Jun 28;327(24):2456. doi: 10.1001/jama.2022.7430. No abstract available.
- Renu A, Fernandez-Couto MD, de la Riva P, Delgado-Mederos R, Herrera M, Morales A, Terceno M, Lopez-Hernandez N, Martinez-Galdamez M, Dorado L, Vega P, Morales-Caba L, Gonzalez E, Alonso M, Barredo Benitez P, Bermejo R, Cabero-Arnold A, Cabrera-Maqueda JM, Vargas M, Calleja Bonilla A, Calleja S, Diaz-Perez J, Rudilosso S, Doncel-Moriano A, Feal MJ, Gallego JI, Hurtado P, Laredo C, Llull L, Bartolome I, Martinez-Calvo A, Ortega-Sanchez A, Rodriguez-Vazquez A, Rodriguez-Caamano I, Singla A, Silva Y, Tarruella Hernandez D, Oleaga L, San Roman Manzanera L, Serena J, Freijo MM, Perez de la Ossa N, Castellanos M, Arenillas-Lara JF, Torres F, Leira EC, Amaro S, Urra X, Chamorro A; CHOICE-2 Investigators. Adjunctive Intra-Arterial Alteplase After Successful Thrombectomy for Acute Ischemic Stroke: The CHOICE-2 Randomized Clinical Trial. JAMA. 2026 Jun 2;335(21):1859-1869. doi: 10.1001/jama.2026.5164.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年11月18日
初级完成 (实际的)
2025年8月26日
研究完成 (实际的)
2025年11月14日
研究注册日期
首次提交
2023年3月9日
首先提交符合 QC 标准的
2023年3月21日
首次发布 (实际的)
2023年4月4日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月15日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- CHOICE 2
- 2023-504262-32 (EudraCT编号)
- 2023 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Deidentified individual participant data on outcome measures will be published along with the main results of the trial.
IPD 共享时间框架
The data will become available after publication of main study results.
IPD 共享访问标准
The IPD will be available from the Sponsor of the trial on reasonable request.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.