Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT07111559
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059409', 'term': 'Stroke, Lacunar'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000083244', 'term': 'Thrombotic Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety - symptomatic intracerebral hemorrhage', 'timeFrame': 'At 24 hours from the initial treatment', 'description': 'symptomatic intracerebral hemorrhage'}, {'measure': 'Safety - any intracranial bleeding', 'timeFrame': 'At 14 days from admission', 'description': 'any intracranial bleeding'}, {'measure': 'Safety - other hemorrhagic complications', 'timeFrame': 'At 14 days from admission', 'description': 'other hemorrhagic complications'}, {'measure': 'Safety - all-cause mortality', 'timeFrame': 'At 3 months', 'description': 'all-cause mortality'}, {'measure': 'Safety - cerebrovascular death', 'timeFrame': 'At 3 months', 'description': 'cerebrovascular death'}], 'primaryOutcomes': [{'measure': 'Excellent outcome', 'timeFrame': '3 months after stroke', 'description': 'Modified Rankin scale score of 0-1'}], 'secondaryOutcomes': [{'measure': 'Infarct growth between Day 7 and admission', 'timeFrame': 'At Day 7', 'description': 'Infarct growth between Day 7 and admission on diffusion-weighted imaging'}, {'measure': 'Early neurological deterioration', 'timeFrame': 'At Day 7', 'description': 'Increment in NIHSS score by 2 points or more from admission'}, {'measure': 'NIHSS score on Day 7', 'timeFrame': 'At Day 7', 'description': 'NIHSS score on Day 7'}, {'measure': 'Good outcome', 'timeFrame': 'At 3 months', 'description': 'mRS 0-2 at 3 months from stroke onset'}, {'measure': 'mRS distribution at 3 months', 'timeFrame': 'At 3 months', 'description': 'mRS distribution (assessed by shift analysis) at 3 months from onset'}, {'measure': 'Ischemic stroke recurrence', 'timeFrame': 'At 3 months', 'description': 'Ischemic stroke recurrence during 3 months from onset'}, {'measure': 'Cost effectiveness of DAPT', 'timeFrame': 'Various (such as at 7 days or 3 months)', 'description': 'Cost effectiveness analysis comparing DAPT to rt-PA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rt-PA', 'tissue-plasminogen activator', 'DAPT', 'dual antiplatelet therapy'], 'conditions': ['Lacunar Stroke', 'Stroke', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a combination of antiplatelet drugs works better than intravenous tissue plasminogen activator to treat small ischemic stroke (lacunar stroke). The main questions it aims to answer are:\n\nIs a combination of antiplatelet drugs non-inferior to the current standard tissue plasminogen activator treatment? Does a combination of antiplatelet drugs reduce the bleeding complications than tissue plasminogen activator?\n\nResearchers will compare a combination of antiplatelet drugs to tissue plasminogen activator to see if a combination of antiplatelet drugs works to treat small ischemic stroke (lacunar stroke).\n\nParticipants will:\n\nTake a combination of antiplatelet drugs or be given intravenous tissue plasminogen activator Check the neurological status 3 months after stroke, in-person, by phone, or by mail.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Acute ischemic stroke within 4.5 hours from onset. If onset time is unknown because of impaired consciousness or aphasia, use the "last known well" time.\n* A single perforating-artery infarct on brain MRI:\n\nlocated in the corona radiata, putamen, internal capsule, thalamus, or pons; solitary, mainly round or oval, with a maximum diameter ≤ 20 mm; lesions only in the centrum semiovale are not allowed, but extension from the above sites into the centrum semiovale is allowed.\n\n* No disability in daily life before the stroke (modified Rankin Scale ≤ 1).\n* National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Antithrombotic therapy considered inappropriate because of active bleeding, low platelet count, or similar conditions.\n* Any contraindication to intravenous rt-PA, without blood pressures.\n* ≥ 50 % stenosis or occlusion of the artery responsible for the stroke \\* (see note below).\n* Diseases that require anticoagulation (e.g., atrial fibrillation, deep-vein thrombosis) \\*\n* Inability to take medicine orally.\n* Any other reason judged by the principal investigator or co-investigators to make participation inappropriate.\n\nNote: This study targets hyper-acute stroke within 4.5 hours. To avoid treatment delay, items marked with \\* must be judged using the similar examinations that each site normally performs before rt-PA administration.'}, 'identificationModule': {'nctId': 'NCT07111559', 'acronym': 'LACUNAR-tPA', 'briefTitle': 'Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Nippon Medical School'}, 'officialTitle': 'A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction', 'orgStudyIdInfo': {'id': 'NMS-M-2024-210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rt-PA', 'interventionNames': ['Drug: rt-PA']}, {'type': 'EXPERIMENTAL', 'label': 'DAPT', 'interventionNames': ['Drug: DAPT']}], 'interventions': [{'name': 'rt-PA', 'type': 'DRUG', 'description': 'Recombinant tissue-plasminogen activator treatment. Low-dose (0.6mg/kg) alteplase will be given because this dosage is the only dosage approved in Japan.', 'armGroupLabels': ['rt-PA']}, {'name': 'DAPT', 'type': 'DRUG', 'description': 'Dual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg.', 'armGroupLabels': ['DAPT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takuya Okata', 'role': 'CONTACT', 'email': 'rimata2585@gmail.com', 'phone': '+81-570-03-1211'}], 'facility': 'Fukuoka Red Cross Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuyama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yuka Terasawa', 'role': 'CONTACT', 'email': 'bbytera@gmail.com', 'phone': '+81-84-931-8650'}], 'facility': 'Ota Memorial Hospital', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'city': 'Kagoshima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Fumio Miyshita', 'role': 'CONTACT', 'email': 'fu-miya@xc4.so-net.ne.jp', 'phone': '+81-99-230-7000'}], 'facility': 'Kagoshima City Hospital', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kagoshima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hideki Matsuoka', 'role': 'CONTACT', 'email': 'hmatsuok0124@yahoo.co.jp', 'phone': '+81-99-223-1151'}], 'facility': 'Kagoshima Medical Center', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Katsuura', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Koichi Nomura', 'role': 'CONTACT', 'email': 'k.nomura@nms.ac.jp', 'phone': '+81-470-73-1221'}], 'facility': 'Shioda Hospital', 'geoPoint': {'lat': 35.14621, 'lon': 140.31507}}, {'city': 'Kawasaki', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hisanao Akiyama', 'role': 'CONTACT', 'email': 'h2akiyama@marianna-u.ac.jp', 'phone': '+81-44-977-8111'}], 'facility': 'St. Marianna University School of Medicine Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Kurashiki', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoshiki Yagita', 'role': 'CONTACT', 'email': 'yyagita@med.kawasaki-m.ac.jp', 'phone': '+81-86-462-1111'}], 'facility': 'Kawasaki Medical School Hospital', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Okayama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takeshi Inoue', 'role': 'CONTACT', 'email': 'inouet@med.kawasaki-m.ac.jp', 'phone': '+81-86-225-2111'}], 'facility': 'Kawasaki Medical School General Medical Center', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Sendai', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yukako Yazawa', 'role': 'CONTACT', 'email': 'yukatin22@gmail.com', 'phone': '+81-22-248-2131'}], 'facility': 'Kohnan Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Tama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Tomonari Saito', 'role': 'CONTACT', 'email': 's00-36@nms.ac.jp', 'phone': '+81-42-371-2111'}], 'facility': 'Nippon Medical School Tamanagayama hospital', 'geoPoint': {'lat': 35.6436, 'lon': 139.46844}}, {'city': 'Tochigi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hidehiro Takekawa', 'role': 'CONTACT', 'email': 'take@dokkyomed.ac.jp', 'phone': '+81-282-86-1111'}], 'facility': 'Dokkyo Medical University Hospital', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'city': 'Tokushima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Nobuaki Yamamoto', 'role': 'CONTACT', 'email': 'nobyamamoto521129@yahoo.co.jp', 'phone': '+81-88-631-3111'}], 'facility': 'Tokushima University Hospital', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Nobukazu Miyamoto', 'role': 'CONTACT', 'email': 'nobu-m@juntendo.ac.jp', 'phone': '+81-3-3813-3111'}], 'facility': 'Juntendo University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yuki Sakamoto', 'role': 'CONTACT', 'email': 'yuki-sakamoto@nms.ac.jp', 'phone': '+81-3-3822-2131', 'phoneExt': '24508'}], 'facility': 'Nippon Medical School hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Koichi Oki', 'role': 'CONTACT', 'email': 'koki.z8@keio.jp', 'phone': '+81-3-3451-8211'}], 'facility': 'Tokyo Saiseikai Central Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takao Hoshino', 'role': 'CONTACT', 'email': 'hoshino.takao@twmu.ac.jp', 'phone': '+81-3-3353-8111'}], 'facility': "Tokyo Women's Medical University Hospital", 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Ube', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hideyuki Ishihara', 'role': 'CONTACT', 'email': 'hishi@yamaguchi-u.ac.jp', 'phone': '+81-836-22-2111'}], 'facility': 'Yamaguchi University Hospital', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}, {'city': 'Urayasu', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takao Urabe', 'role': 'CONTACT', 'email': 't_urabe@juntendo.ac.jp', 'phone': '+81-47-353-3111'}], 'facility': 'Juntendo University Urayasu Hospital', 'geoPoint': {'lat': 35.65879, 'lon': 139.90055}}], 'centralContacts': [{'name': 'Yuki Sakamoto', 'role': 'CONTACT', 'email': 'yuki-sakamoto@nms.ac.jp', 'phone': '+81-3-3822-2131', 'phoneExt': '24508'}], 'overallOfficials': [{'name': 'Yuki Sakamoto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nippon Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'On reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nippon Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Japan Research Foundation for Clinical Pharmacology', 'class': 'UNKNOWN'}, {'name': 'Takeda Science Foundation - Medical Research Grant', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yuki Sakamoto', 'investigatorAffiliation': 'Nippon Medical School'}}}}