Kemisk optimering av cerebral embolektomi 2 (VAL 2). (CHOICE2)
15 september 2026 uppdaterad av: Angel Chamorro, M.D., Ph.D., Hospital Clinic of Barcelona
Kemisk optimering av cerebral embolektomi hos patienter med akut stroke behandlade med mekanisk trombektomi 2 (VAL 2 FÖRSÖK)
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
440
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Spain
-
A Coruña, Spain, Spanien
- Hospital Universitario de A Coruña
-
Alicante, Spain, Spanien
- Hospital Universitario Dr. Balmis
-
Badalona, Spain, Spanien
- Hospital Germans Trías i Pujol
-
Barcelona, Spain, Spanien, 08014
- Hospital Clinic Barcelona
-
Barcelona, Spain, Spanien
- Hospital de la Santa Creu i Sant Pau
-
Bilbao, Spain, Spanien
- Hospital Universitario de Cruces
-
Girona, Spain, Spanien
- Hospital Josep Trueta
-
Murcia, Spain, Spanien
- Hospital Universitario Virgen de la Arrixaca
-
Oviedo, Spain, Spanien
- Hospital Universitario Central de Asturias
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Palma de Mallorca, Spain, Spanien
- Hospital Universitario Son Espases
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Pamplona, Spain, Spanien
- Hospital Universitario de Navarra
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San Sebastián, Spain, Spanien
- Hospital Universitario de Donostia
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Valencia, Spain, Spanien
- Hospital Univesitario y Politénico La Fe
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Valladolid, Spain, Spanien
- Hospital Universitario de Valladolid
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
|
Inget ingripande: No intervention
Patients allocated to this arm will receive a similar care to patients allocated to IA alteplase except the thrombolytic |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Modified Rankin Scale at day 90
Tidsram: 90 days post treatment
|
Proportion of patients with Modified Rankin Scale 0 or 1 at day 90 +/- 15d |
90 days post treatment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Microvascular hypoperfusion on follow-up brain CTP
Tidsram: 36±24hours post treatment
|
Proportion of patients with abnormal microvascular hypoperfusion on CT Perfusion |
36±24hours post treatment
|
|
Volume of hypoperfusion on brain CTP
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
SAFETY OUTCOME: Mortality at 90 days
Tidsram: Day 90
|
Mortality at 90 days |
Day 90
|
|
SAFETY OUTCOME: symptomatic intracerebral hemorrahge (sICH ) rate at 24 hours.
Tidsram: 24hours post MT
|
Symptomatic ICH will be classified as per the European Cooperative Acute Stroke Study (ECASS) 3 criteria |
24hours post MT
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Juan F Arenillas, MD, Hospital Universitario de Valladolid
- Huvudutredare: María del Mar Freijo, MD, Hospital Universitario de Cruces
- Huvudutredare: Pedro Vega, MD, Hospital Universitario Central de Asturias
- Studiestol: Angel Chamorro, MD, PhD, Comprehensive Stroke Center, Hospital Clinic Barcelona
- Huvudutredare: Arturo Renú, MD, PhD, Comprehensive Stroke Center, Hospital Clinic Barcelona
- Huvudutredare: Patricia de la Riva, MD, Hospital Donostia
- Huvudutredare: M Dolores Fernándes, MD, Hospital Universitario de A Coruña
- Huvudutredare: Lluis Morales, MD, Hospital Universitario La Fe de Valencia
- Huvudutredare: Laura Dorado, MD, Hospital Germans Trias i Pujol de Badalona
- Huvudutredare: Mikel Terceño, MD, Hospital Universitario Dr. Josep Trueta de Girona
- Huvudutredare: Ana Morales, MD, Hospital Universitario Virgen de Arrixaca Murcia
- Huvudutredare: Maria Herrera, MD, Hospital of Navarra
- Huvudutredare: Raquel Delgado, MD, Hospital Universitario Son Espases Mallorca
- Huvudutredare: Nicolás López, MD, Hospital Universitario Dr. Balmis Alicante
- Huvudutredare: Pol Camps, MD, Hospital Universitario de la Santa Creu i Sant Pau Barcelona
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 november 2023
Primärt slutförande (Faktisk)
26 augusti 2025
Avslutad studie (Faktisk)
14 november 2025
Studieregistreringsdatum
Först inskickad
9 mars 2023
Först inskickad som uppfyllde QC-kriterierna
21 mars 2023
Första postat (Faktisk)
4 april 2023
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHOICE 2
- 2023-504262-32 (EudraCT-nummer)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Deidentified individual participant data on outcome measures will be published along with the main results of the trial.
Tidsram för IPD-delning
The data will become available after publication of main study results.
Kriterier för IPD Sharing Access
The IPD will be available from the Sponsor of the trial on reasonable request.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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