Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01600235
Status:
UNKNOWN
Last Update Posted:
2017-04-26
First Post:
2012-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D018450', 'term': 'Disease Progression'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2012-05-13', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': 'Day 0 and Day 7', 'description': '2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy outcome', 'timeFrame': 'Day 90 for 1, 2 and Day 7 for 3', 'description': '1. modified Rankin scale (mRS)≤ 2 at day 90\n2. modified Bathel index (mBI)≥ 90 at day 90\n3. Infarct growth or new ischemic lesion on follow-up MRI'}, {'measure': 'Major safety outcome', 'timeFrame': 'From date of randomization until the date of first documented progression by intracranial hemorrhage or cerebral edema, date of myocardial infarction, or date of death from any cause, whichever came first, assessed up to 3 months', 'description': '1. Symptom aggravation by intracranial hemorrhage or cerebral edema (Clinical deterioration causing an increase in the NIHSS score of more than or equal to 4 points and if the hemorrhage or edema was liley to be the cause of the clinical deterioration)\n2. Myocardial infarction\n3. death from any cause'}, {'measure': 'Minor safety outcome', 'timeFrame': 'From date of randomization until the date of first documented intracranial hemorrhage on follow-up MRI, or date of first documented side effects, whichever came first, assessed up to 3 months', 'description': '1. Intracranial hemorrhage on follow-up MRI\n2. Side effects including headache, arrhythmia, chest pain, dysuria, or gastrointestinal hemorrhage'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke, ischemic', 'Progression', 'Induced-hypertension', 'Phenylephrine'], 'conditions': ['Stroke, Acute', 'Progressing Stroke']}, 'referencesModule': {'references': [{'pmid': '31645472', 'type': 'DERIVED', 'citation': 'Bang OY, Chung JW, Kim SK, Kim SJ, Lee MJ, Hwang J, Seo WK, Ha YS, Sung SM, Kim EG, Sohn SI, Han MK. Therapeutic-induced hypertension in patients with noncardioembolic acute stroke. Neurology. 2019 Nov 19;93(21):e1955-e1963. doi: 10.1212/WNL.0000000000008520. Epub 2019 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of the induced hypertension using phenylephrine in patients with noncardioembolic ischemic stroke.\n\nThe investigators hypothesized that phenylephrine induced-hypertension can result in good clinical response without serious complications in patients with noncardioembolic ischemic stroke.', 'detailedDescription': 'See below'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute ischemic stroke confirmed by diffusion-weighted imaging (DWI) performed within 24 hours of symptom onset or symptom worsening(defined by a 2-point or more increase in NIH stroke scale (NIHSS)score including one or more increase in the motor score of affected upper and lower limbs in NIHSS during hospitalization or clear history of symptom worsening judged by investigator before hospitalization) confirmed by DWI performed within 24 hours of aggravation.\n* Baseline NIHSS score 4-18 points\n* Alert mental status\n* Newly developed paresis, aphasia, or neglect\n\nExclusion Criteria:\n\n* Patients underwent recanalization therapy\n* Systolic blood pressure \\>170 mmHg at baseline\n* Patients with history or at risk of hemorrhagic stroke\n* History of significant arrhythmia (e.g. atrial fibrillation)\n* Unable to perform MRI scans or undergo MRI scans \\> 24 hours of symptom onset or progression\n* Large cortical infarction on DWI (more than 1/2 of middle cerebral artery territory)\n* 3 or more cortical microbleeds on gradient-echo MRI\n* Coronary artery disease, congestive heart failure, or hypertrophic cardiomyopathy\n* Anticoagulation therapy (phenylephrine group only)\n* Patients with high-risk cardioembolic sources\n* Cervical or cerebral artery dissection or unruptured aortic/cerebral arterial aneurysm\n* Decreased consciousness\n* Pregnant or Lactating patient\n* Seizure at stroke onset\n* Life expectancy \\< 6 months\n* Pre-stroke modified Rankin scale (mRS) \\>= 2\n* Patients without informed consent'}, 'identificationModule': {'nctId': 'NCT01600235', 'briefTitle': 'Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Safety and Efficacy of Therapeutic Induced Hypertension in Patients With Acute Non-cardioembolic Ischemic Stroke: A Multicenter, Randomized, Open Label, Prospective, Phase 3 Study', 'orgStudyIdInfo': {'id': '2012-01-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenylephrine', 'description': 'Phenylephrine induced-hypertension arm', 'interventionNames': ['Drug: Phenylephrine']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional treatment', 'description': 'Control arm'}], 'interventions': [{'name': 'Phenylephrine', 'type': 'DRUG', 'description': 'Phenylephrine (0.12mg/mL) Starting dose: 10cc/hr Titration: increase 10cc/hr every 30-60min, maximum 160cc/hr rate: increase systolic blood pressure (SBP) 10-25mmHg /hr Target: initially 20% increase of initial SBP, up to improving NIHSS score or SBP 200mmHg', 'armGroupLabels': ['Phenylephrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Suk Jae Kim, MD', 'role': 'CONTACT', 'email': 'sukjae.kim@gmail.com', 'phone': '82234101895'}, {'name': 'Oh Young Bang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kwang Ho Lee, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chin-Sang Chung, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gyeong-Moon Kim, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sung-Ji Park, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Suk Jae Kim, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sookyung Ryoo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Samsung Medical Center, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Oh Young Bang, MD', 'role': 'CONTACT', 'email': 'nmboy@unitel.co.kr', 'phone': '82-10-3410-3599'}, {'name': 'Mi Hyun Seo, RN', 'role': 'CONTACT', 'email': 'mh84.seo@samsung.com', 'phone': '82-10-3410-0934'}], 'overallOfficials': [{'name': 'Oh Young Bang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Inje University', 'class': 'OTHER'}, {'name': 'Gyeongsang National University Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, {'name': 'Yeungnam University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Oh Young Bang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}