Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-27 @ 12:57 AM
Study NCT ID:
NCT05948566
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2023-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategy for Improving Stroke Treatment Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Model Description: The first 50 subjects will be randomized equally to the five arms. Response Adaptive Randomization updates will occur every 50 subjects, thereafter, (favoring doses with maximum utility). For each block of 50 subjects, 13 will be allocated to control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2023-07-08', 'studyFirstSubmitQcDate': '2023-07-08', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with ANY intracerebral hemorrhage (ICH)', 'timeFrame': 'At 30 (+/- 4) hours after study drug', 'description': 'Any ICH visualized on the follow-up CT scan'}, {'measure': 'Stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': 'At 30 (+/- 4) hours after study drug', 'description': 'NIHSS is a stroke severity score that ranges from 0 to 42, with higher numbers indicating a more severe stroke. The NIHSS will be adjusted for the baseline value in analysis.'}], 'secondaryOutcomes': [{'measure': 'Improvement in level of global disability measured by modified Rankin Score (mRS distribution)', 'timeFrame': '90 (±7) days', 'description': 'The modified Rankin Score assessment is a 7-level disability scale that measures the degree of disability or dependence in daily activities of people who have suffered a stroke. Range 0= no disability and 6=dead.'}, {'measure': 'Frequency of Modified Rankin (mRS) score of 0-1 or returning to pre-stroke mRS.', 'timeFrame': 'Proportion of patients with modified Rankin scale score 0-1 or return to pre-stroke mRS at 90 (+/-7) days.', 'description': 'Proportion of patients with modified Rankin scale score 0-1 or return to pre-stroke mRS.'}, {'measure': 'NIHSS', 'timeFrame': '72 (±12) hours (or at discharge if sooner) after study drug administration.', 'description': 'NIHSS is a stroke severity score that ranges from 0 to 42, with higher numbers indicating a more severe stroke. The NIHSS will be adjusted for the baseline value in analysis.'}, {'measure': 'α2-antiplasmin (a2AP) level in plasma', 'timeFrame': 'at 3 (±1) h after completion of study drug administration', 'description': 'A serine protease inhibitor responsible for inactivating plasmin.'}, {'measure': 'Matrix metalloproteinase-9 level in plasma', 'timeFrame': '3 (±1) h after completion of study drug', 'description': 'An enzyme that regulates the pathological remodeling process that involve inflammation and fibrosis associated with cardiovascular disease.'}, {'measure': '% brain tissue reperfusion', 'timeFrame': '30 (±4) h after study drug administration', 'description': 'Proportion of brain tissue that is reperfused on the follow-up perfusion scan compared to the baseline, calculated as:\n\n(\\[baseline minus follow up perfusion imaging area of hypoperfusion\\]/ baseline area of hypoperfusion); hypoperfusion=T max\\>6 seconds'}, {'measure': 'Pharmacokinetic analyses', 'timeFrame': '3 (±1) h, 30 (±4) h, 30 (±5) days & 90 (±7) days after study drug administration. At 90 (±7) days for approximately 50 mITT participants. After approximately 50 mITT participants, it will be obtained at 72h(+12 hrs)/discharge visit, whichever comes 1st.', 'description': 'Measure of plasma concentrations of TS23'}, {'measure': 'Evaluation of anti-drug antibodies', 'timeFrame': 'will be measured at baseline and 90 (±7) days follow-up visit for approximately 50 mITT participants.', 'description': 'commonly used for characterization of therapeutic antibodies'}, {'measure': 'Proportion of patients with symptomatic intracerebral hemorrhage', 'timeFrame': '30 (±4) h of study drug administration', 'description': 'a blood clot large enough to cause significant neurological deterioration.'}, {'measure': 'Proportion of patients with non-intracerebral hemorrhage major or clinically relevant non-major bleeding', 'timeFrame': '30 days of study drug administration.', 'description': 'major and non-major events of bleeding that is not in the brain'}, {'measure': 'Plasma fibrinogen level', 'timeFrame': '3 (±1) h after completion of study drug', 'description': 'Clotting factor'}, {'measure': 'Proportion of patients with non-bleeding severe adverse events', 'timeFrame': '90 (±7) days', 'description': 'Assessment of untoward events'}, {'measure': 'Proportion of patients with stroke-related and all-cause deaths', 'timeFrame': '90 (±7) days', 'description': 'measure of important patient outcomes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke.', 'detailedDescription': 'SISTER is a Phase II, Bayesian, adaptive, randomized, dose-finding trial of TS23 in patients with acute ischemic stroke. Patients with an anterior cerebral circulation acute ischemic stroke and present between 4.5 to 24 hours of their last known well with a presenting NIH Stroke Scale Score \\>/=4 (with the patient having a clearly disabling deficit if the NIHSS is 4 or 5) and an imaging evidence of salvageable brain tissue will be eligible and will be approached for an informed consent for study participation. After informed consent is provided, the study will randomize to 4 doses of TS23 and placebo. The trial will enroll up to 300 subjects at up to 60 participating US sites and up to 17 Canadian sites.\n\nThe effects of TS23 will be evaluated on two following primary outcomes using a utility function: 1) primary safety outcome: any intracerebral hemorrhage at 30 (+/-4) hours and 2) primary efficacy outcome: NIH Stroke Scale score at 30 (+/-4) hours after drug administration. The study will follow participants for 90 (+/-7) days.\n\nPrimary Objective: To identify a dose of TS23 that is safe and more efficacious than placebo for the treatment of patients from 4.5 to 24 hours of last known well, who have evidence of core-penumbra mismatch on perfusion imaging and are not a candidate for standard of care reperfusion therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 years and older\n2. Suspected anterior circulation acute ischemic stroke\n3. NIH Stroke Scale score ≥4 prior to randomization\n\n a. The participant must have a clearly disabling deficit if NIHSS is 4-5.\n4. Favorable baseline neuroimaging consisting of all of the following:\n\n 1. ASPECTS of 6 or more on CT (or ASPECTS of ≥7 on MRI)\n 2. Favorable perfusion imaging on CT perfusion (CTP)/MR-perfusion weighted imaging (PWI) consisting of all of the following:\n\n i. Mismatch ratio of penumbra: core \\>1.2 ii. Mismatch volume \\>10 cc iii. Core \\<70 cc\n\n c. If CT hypodensity is present, then in the investigator's visual assessment, the total acute infarct volume combined area of (a) the CT hypodensity and (b) the perfusion-based core volume (CBF\\<30%) should be smaller than perfusion-based volume (area of Tmax\\>6s minus CBF\\<30%).\n5. Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well.\n6. Able to receive assigned study drug within 120 minutes of qualifying perfusion imaging. \\*\n7. Informed consent for the study participation obtained from participant or their legally authorized representatives.\n\n * Study drug administration is encouraged within 90 minutes after qualifying perfusion image but is allowed up to 120 minutes. After 120 minutes, another perfusion image to ensure that inclusion criteria are met is required.\n\nExclusion Criteria:\n\n1. Received endovascular treatment with clot engagement.\n\n 1. Patients who undergo groin puncture but clot engagement is not attempted due to spontaneous distal migration are permitted to be enrolled in the trial if all other eligibility criteria are met.\n 2. Patients who undergo groin puncture but clot is not engaged due to reasons other than spontaneous distal migration are NOT permitted.\n2. Received or planned to receive intravenous thrombolysis.\n3. Pre-stroke modified Rankin score \\>2.\n4. Previous treatment with TS23 or known previous allergy to antibody therapy.\n5. Known pregnancy, women who are breastfeeding or plan to breastfeed within 3 months of receiving TS23 or have a positive urine or serum pregnancy test for women of childbearing potential.\n6. Known previous stroke in the past 90 days.\n7. Known previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arterial venous malformation.\n8. Known active diagnosis of intracranial neoplasm.\n9. Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal.\n10. Surgery or biopsy of parenchymal organ in the past 30 days.\n11. Known trauma with internal injuries or persistent ulcerative wounds in the past 30 days.\n12. Severe head trauma in the past 90 days.\n13. Persistent systolic blood pressure \\>180mmHg or diastolic blood pressure \\>105mmHg despite best medical management.\n14. Serious systemic hemorrhage in the past 30 days.\n15. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with International Normalized Ratio (INR) \\>1.7.\n16. Platelets \\<100,000/mm3.\n17. Hematocrit \\<25 %.\n18. Elevated aPTT above laboratory upper limit of normal.\n19. Creatinine \\> 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine.\n20. Received the following within the previous 24 hours:\n\n 1. If patient received unfractionated heparin within the last 24 hours, the patient must have an aPTT within normal range prior to enrollment.\n 2. Low molecular weight heparins such as Dalteparin, enoxaparin, tinzaparin in full dose within the previous 24 hours.\n21. Received Factor Xa inhibitors (such as Fondaparinux, apixaban or rivaroxaban) within the past 48 hours.\n22. Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours.\n23. Received glycoprotein IIb/IIIa inhibitors within the past 14 days.\n24. Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations.\n25. Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days).\n26. Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment."}, 'identificationModule': {'nctId': 'NCT05948566', 'acronym': 'SISTER', 'briefTitle': 'Strategy for Improving Stroke Treatment Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'Translational Sciences, Inc.'}, 'officialTitle': 'Strategy for Improving Stroke Treatment Response (SISTER) Trial', 'orgStudyIdInfo': {'id': 'TS23-U202'}, 'secondaryIdInfos': [{'id': 'UH3NS125023', 'link': 'https://reporter.nih.gov/quickSearch/UH3NS125023', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Biological: TS23']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 1 TS23', 'description': 'low dose', 'interventionNames': ['Biological: TS23']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 TS23', 'description': 'next higher dose', 'interventionNames': ['Biological: TS23']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 TS23', 'description': 'next higher dose', 'interventionNames': ['Biological: TS23']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4 TS23', 'description': 'highest dose', 'interventionNames': ['Biological: TS23']}], 'interventions': [{'name': 'TS23', 'type': 'BIOLOGICAL', 'description': 'Monoclonal antibody', 'armGroupLabels': ['Dose 1 TS23', 'Dose 2 TS23', 'Dose 3 TS23', 'Dose 4 TS23', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Felix Guerra Castanon, MD', 'role': 'CONTACT', 'email': 'fguerracastanon@uabmc.edu'}, {'name': 'Felix Guerra Castanon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Savdeep Singh, MD', 'role': 'CONTACT', 'email': 'savdeepsingh@arizona.edu'}, {'name': 'Savdeep Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Banner University Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Mayo Clinic Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Firas Kaddouh, MD, MHS', 'role': 'CONTACT', 'email': 'firaskaddouh@arizona.edu'}, {'name': 'Firas Kaddouh, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maryo Jajo', 'role': 'CONTACT', 'email': 'mjajo@health.ucsd.edu'}, {'name': 'Royya Modir, MD', 'role': 'CONTACT', 'email': 'rmodir@ucsd.edu'}, {'name': 'Royya Modir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSD Health La Jolla', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Navdeep Sangha, MD', 'role': 'CONTACT', 'email': 'navdeep.x.sangha@kp.org'}, {'name': 'Navdeep Sangha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Sutter Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maryo Jajo', 'role': 'CONTACT', 'email': 'mjajo@health.ucsd.edu'}, {'name': "Royya' Modir, MD", 'role': 'CONTACT', 'email': 'rmodir@ucsd.edu'}, {'name': 'Royya Modir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSD Medical Center- Hillcrest Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ajay Tunguturi, MD', 'role': 'CONTACT', 'email': 'ajay.tunguturi@hhchealth.org'}, {'name': 'Ajay Tunguturi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Giles, MD, PhD', 'role': 'CONTACT', 'email': 'james.giles@yale.edu'}, {'name': 'James Giles, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Nomura, MD', 'role': 'CONTACT', 'email': 'jnomura@christianacare.org'}, {'name': 'Jason Nomura, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amita Singh, MD, MS', 'role': 'CONTACT', 'email': 'Amita.Singh@neurology.ufl.edu'}, {'name': 'Amita Singh, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UF Health Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrea Escobar', 'role': 'CONTACT', 'email': 'a.escobar1@med.miami.edu'}, {'name': 'Gillian Gordon Perue, MD, MBBS, DM', 'role': 'CONTACT', 'email': 'ggordonperue@miami.edu'}, {'name': 'Gillian Gordon Perue, MD, MBBS, DM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicolas Bianchi, MD', 'role': 'CONTACT', 'email': 'nicolas.a.bianchi@emory.edu'}, {'name': 'Nicolas Bianchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Siegler, MD, FAHA', 'role': 'CONTACT', 'email': 'James.Siegler@bsd.uchicago.edu'}, {'name': 'James Siegler, MD, FAHA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heena Olalde', 'role': 'CONTACT', 'email': 'heena-olalde@uiowa.edu'}, {'name': 'Enrique Leira, MD', 'role': 'CONTACT', 'email': 'enrique-leira@uiowa.edu'}, {'name': 'Enrique Leira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa Hospitals & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Murali Kolikonda, MD', 'role': 'CONTACT', 'email': 'murali.kolikonda@bhsi.com'}, {'name': 'Franklin Echevarria', 'role': 'CONTACT', 'email': 'Franklin.echevarriagonzalez@bhsi.com'}, {'name': 'Murali Kolikonda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baptist Healthcare System, Inc.', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isaac Abecassis, MD', 'role': 'CONTACT', 'email': 'Isaac.Abecassis@uoflhealth.org'}, {'name': 'Isaac Abecassis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Louisville Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rahul Mahajan, MD, PhD', 'role': 'CONTACT', 'email': 'rmahajan@bwh.harvard.edu'}, {'name': 'Rahul Mahajan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02171', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aneesh Singhal, MD, MBBS', 'role': 'CONTACT', 'email': 'ASINGHAL@mgh.harvard.edu'}, {'name': 'Aneesh Singhal, MD, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55337', 'city': 'Burnsville', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Staloch', 'role': 'CONTACT', 'email': 'staloch@umn.edu'}, {'name': 'Muhammad Affan, MD, MBBS', 'role': 'CONTACT', 'email': 'affan004@umn.edu'}, {'name': 'Muhammad Affan, MD, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M Health Fairview Ridges Hospital', 'geoPoint': {'lat': 44.76774, 'lon': -93.27772}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Staloch', 'role': 'CONTACT', 'email': 'staloch@umn.edu'}, {'name': 'Muhammad Affan, MD,MBBS', 'role': 'CONTACT', 'email': 'affan004@umn.edu'}, {'name': 'Muhammad Affan, MD, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M Health Fairview Southdale Hospital', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Staloch', 'role': 'CONTACT', 'email': 'staloch@umn.edu'}, {'name': 'Muhammad Affan, MD,MBBS', 'role': 'CONTACT', 'email': 'affan004@umn.edu'}, {'name': 'Muhammad Affan, MD,MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M Health Fairview University of Minnesota Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ganesh Asaithambi, MD', 'role': 'CONTACT', 'email': 'Ganesh.Asaithambi@allina.com'}, {'name': 'Ganesh Asaithambi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'United Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Kircher, MD', 'role': 'CONTACT', 'email': 'charles.kircher@wustl.edu'}, {'name': 'Charles Kircher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08837', 'city': 'Edison', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Gadallah, DO', 'role': 'CONTACT', 'email': 'nancy.gadallah@hmhn.org'}, {'name': 'Nancy Gadallah, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'JFK Medical Center', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '11220', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Cotrina-Vidal', 'role': 'CONTACT', 'email': 'maria.cotrina@nyulangone.org'}, {'name': 'Aaron Lord, MD, MSc', 'role': 'CONTACT', 'email': 'aaron.lord@nyulangone.org'}, {'name': 'Aaron Lord, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Buffalo General Medical Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rohan Arora', 'role': 'CONTACT', 'email': 'neuroscienceresearch@northwell.edu'}, {'name': 'Rohan Arora, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Stein, MD, MPH', 'role': 'CONTACT', 'email': 'laura.stein@mountsinai.org'}, {'name': 'Laura Stein, 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'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deb Lena', 'role': 'CONTACT', 'email': 'debl@upstate.edu'}, {'name': 'Julius-Gene LaTorre, MD, MPH', 'role': 'CONTACT', 'email': 'latorrej@upstate.edu'}, {'name': 'Julius-Gene LaTorre, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gurmeen Kaur, MD', 'role': 'CONTACT', 'email': 'Gurmeen.Kaur@wmchealth.org'}, {'name': 'Gurmeen Kaur, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westchester Medical Center', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rosanna Escobar-Spadina', 'role': 'CONTACT', 'email': 'rosanna.escobar@duke.edu'}, {'name': 'Alexander Limkakeng, MD, MHSc', 'role': 'CONTACT', 'email': 'alexander.limkakeng@duke.edu'}, {'name': 'Alexander Limkakeng, MD, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yasmin Aziz, MD', 'role': 'CONTACT', 'email': 'azizyn@ucmail.uc.edu'}, {'name': 'Yasmin Aziz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jan Bittar, MD', 'role': 'CONTACT', 'email': 'jan.bittar@osumc.edu'}, {'name': 'Jan Bittar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OSU Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rahul Rahangdale, MD', 'role': 'CONTACT', 'email': 'rahul.rahangdale@ascension.org'}, {'name': 'Rahul Rahangdale, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ascension St. John', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kishan Patel, MD', 'role': 'CONTACT', 'email': 'kishan.patel@providence.org'}, {'name': 'Kishan Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': 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{'name': 'Farhan Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '32608', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caitlan LeMatty', 'role': 'CONTACT', 'email': 'lemattyc@musc.edu'}, {'name': 'Christine Holmstedt, DO', 'role': 'CONTACT', 'email': 'holmsted@musc.edu'}, {'name': 'Christine Holmstedt, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of South Carolina University Hospital', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sanjeev Sivakumar, MD', 'role': 'CONTACT', 'email': 'Sanjeev.Sivakumar@prismahealth.org'}, {'name': 'Sanjeev Sivakumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prisma Health Greenville Memorial', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Quentin Thacker', 'role': 'CONTACT', 'email': 'qthacker@uthsc.edu'}, {'name': 'Balaji Krishnaiah, MD', 'role': 'CONTACT', 'email': 'bkrishn4@uthsc.edu'}, {'name': 'Balaji Krishnaiah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Methodist University Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Prasen Marella', 'role': 'CONTACT', 'email': 'prasen.r.marella@uth.tmc.edu'}, {'name': 'Andrew Barreto, MD, MS', 'role': 'CONTACT', 'email': 'andrew.d.barreto@uth.tmc.edu'}, {'name': 'Andrew Barreto, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Hermann Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vivek Reddy, MD, MMM', 'role': 'CONTACT', 'email': 'Vivek.Reddy@hsc.utah.edu'}, {'name': 'Vivek Reddy, MD, MMM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah Healthcare', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22901', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amna Sohail, MBBS, MD', 'role': 'CONTACT', 'email': 'ZRX5FU@uvahealth.org'}, {'name': 'Amna Sohail, MBBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UVA Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shraddha Mainali, MD', 'role': 'CONTACT', 'email': 'Shraddha.Mainali@vcuhealth.org'}, {'name': 'Shraddha Mainali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VCU Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Tirschwell, MD, MSc.', 'role': 'CONTACT', 'email': 'tirsch@uw.edu'}, {'name': 'David Tirschwell, MD, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53211', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lakiesha Coleman', 'role': 'CONTACT', 'email': 'lakiesha.coleman@ascension.org'}, {'name': 'William Taylor, DO', 'role': 'CONTACT', 'email': 'william.taylor3@ascension.org'}, {'name': 'William Taylor, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Ascension Columbia St. Mary's Hospital", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Rebeca Aragon Garcia, BS, CCRC', 'role': 'CONTACT', 'email': 'aragonra@ucmail.uc.edu', 'phone': '9736688644'}, {'name': 'Pam Plummer, MSN,RN, CCRC', 'role': 'CONTACT', 'email': 'plummepa@ucmail.uc.edu', 'phone': '5138852437'}], 'overallOfficials': [{'name': 'Eva Mistry, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The SISTER trial will comply with the NIH Public Access Policy, which ensures that the public has access to the published results of NIH funded research, and the StrokeNet SOP (ADM 03) regarding results publication. Manuscripts and abstracts that use data from SISTER require approval from the Publication Committee of an original proposal before the concept may proceed. All publications will include this acknowledgement: "Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number \\[to be determined\\]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Translational Sciences, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Cincinnati', 'class': 'OTHER'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'University of Arizona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}