Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT00044057
Status:
COMPLETED
Last Update Posted:
2006-04-03
First Post:
2002-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C110629', 'term': 'YM 872'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'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': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2003-01'}, 'lastUpdateSubmitDate': '2006-03-31', 'studyFirstSubmitDate': '2002-08-16', 'studyFirstSubmitQcDate': '2002-08-19', 'lastUpdatePostDateStruct': {'date': '2006-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['ARTIST'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).\n* Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.\n* Patients who are at least 18 years of age.\n* Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.\n* Other criteria as specified in the study protocol\n\nExclusion Criteria:\n\n* Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria.\n* Patients who have stroke of the brainstem or cerebellum.\n* Patients who have renal (kidney) disease or insufficiency.\n* Patients who have active epilepsy or convulsions during the current stroke episode.\n* Patients who are IV drug users or are inebriated.\n* Patients who have a history of drug-related anaphylaxis.\n* Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.\n* Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.\n* Patients who have a known vitamin hypersensitivity.\n* Other exclusion criteria as specified by the study protocol'}, 'identificationModule': {'nctId': 'NCT00044057', 'briefTitle': 'A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients With Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo', 'orgStudyIdInfo': {'id': '872-CL-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'YM872 (zonampanel), t-PA (alteplase)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Stroke Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Region Associates in Neurology', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': "Providence St. Joseph's Medical Center", 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Mercy San Juan Hospital', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Memorial Hospital', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'city': 'La Mesa', 'state': 'California', 'country': 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'facility': 'University of California at San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center - Santa Monica', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Medical Center', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Mt Diablo Medical Center', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Neurological Institute', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'city': 'Bridgeport', 'state': 'Connecticut', 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