Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-03 @ 12:11 PM
Study NCT ID:
NCT01455935
Status:
UNKNOWN
Last Update Posted:
2012-03-30
First Post:
2011-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-29', 'studyFirstSubmitDate': '2011-10-07', 'studyFirstSubmitQcDate': '2011-10-18', 'lastUpdatePostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Scale (mRS)', 'timeFrame': '90 days', 'description': 'Modified Rankin Scale (mRS) 90 days post treatment'}], 'secondaryOutcomes': [{'measure': 'National Institute of Health Stroke Scale (NIHSS)', 'timeFrame': '24 hour', 'description': 'National Institute of Health Stroke Scale (NIHSS) 24 hours post treatment.'}, {'measure': 'National Institute of Health Stroke Scale (NIHSS)', 'timeFrame': '3-29 day', 'description': 'National Institute of Health Stroke Scale (NIHSS) at discharge (3-29 days)'}, {'measure': 'Modified Rankin Scale (mRS)', 'timeFrame': '30 post treatment', 'description': 'Modified Rankin Scale (mRS) at 30 days post treatment'}, {'measure': 'Thrombolysis In Myocardial Infarction (TIMI) Flow', 'timeFrame': 'Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure', 'description': 'Thrombolysis In Myocardial Infarction (TIMI) flow pre and post the intervention as an indicator of revascularization rate'}, {'measure': 'Thomboylsis in Cerebral Ischemia (TICI) flow', 'timeFrame': 'Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure', 'description': 'Thomboylsis in Cerebral Ischemia (TICI) flow pre and post intervention as an indicator of revascularization rate'}, {'measure': 'symptomatic intracranial Hemorrhage (ICH)', 'timeFrame': '72 hours', 'description': 'Incidence of symptomatic symptomatic intracranial Hemorrhage (ICH) within 72 hours of intervention defined by ECASSIII as 4 points worsening in NIHSS'}, {'measure': 'National Institute of Health Stroke Scale (NIHSS)', 'timeFrame': '30 Days', 'description': 'at 30 Day visit National Institute of Health Stroke Scale (NIHSS) will be assessed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of Emergency Department presentation:\n\n1. Age: 18-80 years old\n2. Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal)\n3. National Institute of Health Stroke Scale (NIHSS) 8-22\n4. Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above\n5. Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more)\n6. Signed informed consent\n\nExclusion Criteria:\n\nExclusion Criteria: Potential study patients will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:\n\n1. Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT\n2. Historical Modified Rankin Scale (mRS) of ≥2\n3. National Institute of Health Stroke Scale (NIHSS)\\<8 at the time of treatment\n4. Positive pregnancy test in women at age of childbearing\n5. Intracranial or intraspinal surgery within 3 months\n6. Stroke or serious head injury within 3 months\n7. History of intracranial hemorrhage\n8. Uncontrolled hypertension at time of treatment (eg, \\>185 mm Hg systolic or \\>110 mm Hg diastolic)\n9. Seizure at the onset of stroke\n10. Active internal bleeding\n11. Intracranial neoplasm\n12. Arteriovenous malformation or aneurysm\n13. Clinical presentation suggesting post-MI pericarditis\n14. Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an Internation normalized ratio (INR) \\>1.7\n15. Internation normalized ratio (INR) \\>1.7\n16. Administration of heparin within 48 hours preceding the onset of stroke with an elevated activated Partial Thromboplastin Time(aPTT) at presentation\n17. Platelet count \\<100,000/mm\n18. Major surgery within 2 weeks\n19. GastroIntestinal (GI) or urinary tract hemorrhage within 3 weeks\n20. Aggressive treatment required to lower blood pressure\n21. Glucose level \\<50 or \\>400 mg/dL\n22. Arterial puncture at a noncompressible site or lumbar puncture within 1 week'}, 'identificationModule': {'nctId': 'NCT01455935', 'acronym': 'WASSABI', 'briefTitle': 'Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Jacobs Neurological Institute'}, 'officialTitle': 'Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial', 'orgStudyIdInfo': {'id': 'NEU 3200411A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Medical Therapy', 'description': 'Current standard of care per the latest stroke guidelines\n\n* Permissive Hypertension up to 220\n* Antipletelets therapy:\n\n 1. ASA 81 mg PO daily or\n 2. Plavix 75 mg PO daily or\n 3. Aggrenox 225mg PO twice daily\n* Anti-inflammatory therapy:\n\n 1. Lipitor 80 mg PO daily or\n 2. Crestor 20 mg PO daily', 'interventionNames': ['Drug: Anti-platelets and statin']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous Thrombolysis', 'description': 'Full dose Intravenous thrombolysis\n\n* 0.9 mg/kg\n* Maximum dose is 90 mg\n* 10% of the dose will be given over one minute\n* 90% of the dose will be infused over 1 hour\n* Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications\n* Neuro checks every 5 minutes during the infusion\n* Neuro checks every hour after the infusion for 24 hours', 'interventionNames': ['Drug: alteplase']}, {'type': 'EXPERIMENTAL', 'label': 'Intra-Arterial Therapy', 'description': '-Choice of therapy per experienced Endovascular surgeon and includes:\n\n1. Intra arterial Activase (Maximum dose of 22 mg)\n2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)\n3. PENUMBRA device (no standard time frame for how long the procedure takes)', 'interventionNames': ['Procedure: intra arterial intervention']}], 'interventions': [{'name': 'Anti-platelets and statin', 'type': 'DRUG', 'armGroupLabels': ['Medical Therapy']}, {'name': 'alteplase', 'type': 'DRUG', 'description': 'Full dose Intravenous thrombolysis\n\n* 0.9 mg/kg\n* Maximum dose is 90 mg\n* 10% of the dose will be given over one minute\n* 90% of the dose will be infused over 1 hour\n* Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications\n* Neuro checks every 5 minutes during the infusion\n* Neuro checks every hour after the infusion for 24 hours', 'armGroupLabels': ['Intravenous Thrombolysis']}, {'name': 'intra arterial intervention', 'type': 'PROCEDURE', 'description': '1. Intra arterial Activase (Maximum dose of 22 mg)\n2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)\n3. PENUMBRA device (no standard time frame for how long the procedure takes)', 'armGroupLabels': ['Intra-Arterial Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14209', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annemarie Crumlish', 'role': 'CONTACT', 'email': 'acrumlish@thejni.org', 'phone': '716-887-5548'}, {'name': 'Tareq Kass-Hout, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elad Levy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Adnan H Siddiqui, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kenneth V Snyder, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'L N Hopkins, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert N Sawyer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marilou Ching, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Janicke, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Millard Fillmore Gates Circle Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'centralContacts': [{'name': 'Tareq Kass-Hout, MD', 'role': 'CONTACT', 'email': 'kasshouttareq@gmail.com', 'phone': '716-887-5548'}], 'overallOfficials': [{'name': 'Elad I Levy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University at Buffalo Neurosurgery'}, {'name': 'Tareq Kass-Hout, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jacobs Neurological Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacobs Neurological Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University at Buffalo Neurosurgery', 'class': 'OTHER'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Vascular/Neurology Resident in charge of stroke', 'investigatorFullName': 'Tareq Kass-Hout', 'investigatorAffiliation': 'Jacobs Neurological Institute'}}}}