Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-28 @ 3:45 AM
Study NCT ID:
NCT05797792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHemical OptImization of Cerebral Embolectomy 2 (CHOICE 2).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The evaluation of the primary outcome measure (modified Rankin Scale Score 0-1 at day 90) will be conducted by central blinded evaluators following a structured questionnaire. The evaluation of imaging outcome measures will be conducted at the Imaging Central Core Laboratory by blinded evaluators'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, prospective, randomized, open, blinded end-point assessment phase III trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SAFETY OUTCOME: Mortality at 90 days', 'timeFrame': 'Day 90', 'description': 'Mortality at 90 days'}, {'measure': 'SAFETY OUTCOME: symptomatic intracerebral hemorrahge (sICH ) rate at 24 hours.', 'timeFrame': '24hours post MT', 'description': 'Symptomatic ICH will be classified as per the European Cooperative Acute Stroke Study (ECASS) 3 criteria'}], 'primaryOutcomes': [{'measure': 'Modified Rankin Scale at day 90', 'timeFrame': '90 days post treatment', 'description': 'Proportion of patients with Modified Rankin Scale 0 or 1 at day 90 +/- 15d'}], 'secondaryOutcomes': [{'measure': 'Microvascular hypoperfusion on follow-up brain CTP', 'timeFrame': '36±24hours post treatment', 'description': 'Proportion of patients with abnormal microvascular hypoperfusion on CT Perfusion'}, {'measure': 'Volume of hypoperfusion on brain CTP', 'timeFrame': 'at 36h±24h post treatment', 'description': 'Volume of hypoperfusion on brain CTP'}, {'measure': 'Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP', 'timeFrame': '36±24hours post treatment', 'description': 'Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP at 36±24hours post MT.'}, {'measure': 'Barthel Scale score', 'timeFrame': 'day 90 post treatment', 'description': 'Barthel Scale score of 95 to 100, (min value 0, max value 100, higher score better outcome)'}, {'measure': 'EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L)', 'timeFrame': 'day 90 post treatment', 'description': '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.'}, {'measure': 'Shift analysis of the modified Rankin Scale (mRS)', 'timeFrame': 'day 90 post treatment', 'description': 'Shift analysis of the modified Rankin Scale (mRS), at day 90 (min value 0, max value 6, higher score worse outcome)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mechanical Thrombectomy', 'Recanalization', 'Reperfusion', 'Alteplase'], 'conditions': ['Stroke, Acute Ischemic', 'Stroke, Acute']}, 'referencesModule': {'references': [{'pmid': '28912596', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28318984', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25882510', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31852410', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35143603', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36054449', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35763000', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* 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)\n* Age ≥18\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* NIHSS score on admission \\>25\n* Contraindication to IV t-PA as per local national guidelines (except time to therapy)\n* Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h\n* 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\n* Female who is pregnant or lactating or has a positive pregnancy test at time of admission\n* Current participation in another investigation drug or device treatment study\n* Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency\n* Known coagulopathy, INR \\> 1.7\n* Platelets \\< 50,000\n* Renal Failure as defined by a serum creatinine \\> 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \\[GFR\\] \\< 30\n* Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason\n* Any hemorrhage on CT/MRI\n* Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal\n* Suspicion of aortic dissection\n* Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol\n* History of life-threatening allergy (more than rash) to contrast medium\n* SBP \\>185 mmHg or DBP \\>110 mmHg refractory to treatment\n* Serious, advanced, terminal illness with anticipated life expectancy \\< 6 months\n* Pre-existing neurological or psychiatric disease that would confound evaluation\n* Presumed vasculitis or septic embolization\n* Unlikely to be available for 90-day follow-up (i.e., no fixed home address, visitor from overseas)'}, 'identificationModule': {'nctId': 'NCT05797792', 'acronym': 'CHOICE2', 'briefTitle': 'CHemical OptImization of Cerebral Embolectomy 2 (CHOICE 2).', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'CHemical OptImization of Cerebral Embolectomy in Patients With Acute Stroke Treated With Mechanical Thrombectomy 2 (CHOICE 2 TRIAL)', 'orgStudyIdInfo': {'id': 'CHOICE 2'}, 'secondaryIdInfos': [{'id': '2023-504262-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraarterial alteplase', 'description': "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.", 'interventionNames': ['Drug: Intraarterial alteplase']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Patients allocated to this arm will receive a similar care to patients allocated to IA alteplase except the thrombolytic'}], 'interventions': [{'name': 'Intraarterial alteplase', 'type': 'DRUG', 'otherNames': ['Intraarterial recombinant tissue plasminogen activator (rt-PA)'], 'description': 'See arm/group descriptions.', 'armGroupLabels': ['Intraarterial alteplase']}]}, 'contactsLocationsModule': {'locations': [{'city': 'A Coruña', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Universitario de A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Alicante', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Universitario Dr. Balmis', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Badalona', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Germans Trías i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08014', 'city': 'Barcelona', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bilbao', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Universitario de Cruces', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'Girona', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Murcia', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Oviedo', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Palma de Mallorca', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Universitario Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Pamplona', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'San Sebastián', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Universitario de Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'city': 'Valencia', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Univesitario y Politénico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valladolid', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Angel Chamorro, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Comprehensive Stroke Center, Hospital Clinic Barcelona'}, {'name': 'Arturo Renú, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Comprehensive Stroke Center, Hospital Clinic Barcelona'}, {'name': 'Juan F Arenillas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Valladolid'}, {'name': 'María del Mar Freijo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Cruces'}, {'name': 'Patricia de la Riva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Donostia'}, {'name': 'M Dolores Fernándes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de A Coruña'}, {'name': 'Pedro Vega, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Central de Asturias'}, {'name': 'Lluis Morales, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Fe de Valencia'}, {'name': 'Laura Dorado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Germans Trias i Pujol de Badalona'}, {'name': 'Mikel Terceño, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Dr. Josep Trueta de Girona'}, {'name': 'Ana Morales, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Virgen de Arrixaca Murcia'}, {'name': 'Maria Herrera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital of Navarra'}, {'name': 'Raquel Delgado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Son Espases Mallorca'}, {'name': 'Nicolás López, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Dr. Balmis Alicante'}, {'name': 'Pol Camps, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de la Santa Creu i Sant Pau Barcelona'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data will become available after publication of main study results.', 'ipdSharing': 'YES', 'description': 'Deidentified individual participant data on outcome measures will be published along with the main results of the trial.', 'accessCriteria': 'The IPD will be available from the Sponsor of the trial on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Comprehensive Stroke Center', 'investigatorFullName': 'Angel Chamorro, M.D., Ph.D.', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}