Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-28 @ 7:18 AM
Study NCT ID:
NCT06371495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Statins Role in Acute Ischemic Stroke
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': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-14', 'studyFirstSubmitDate': '2024-04-14', 'studyFirstSubmitQcDate': '2024-04-14', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carotid duplex will be done at the onset and after 1 month and 3 months of the onset.', 'timeFrame': 'first day and after 3 mounths', 'description': 'measure the carotid thickness through Carotid duplex'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute']}, 'referencesModule': {'references': [{'pmid': '4448456', 'type': 'RESULT', 'citation': 'Gandhi BS, Kanungo MS. Effect of cortisone on monoamine oxidase of the liver of young & old rats. Indian J Biochem Biophys. 1974 Jun;11(2):102-4. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Strokes is amajor cause of death and disabilities in different countried', 'detailedDescription': 'Stroke is a major cause of mortality and disability in modern societies. Statins are effective medications in decreasing cardiovascular events through lipid lowering and pleiotropic effects. Ischemic stroke is burdened with a high morbidity and mortality in our society. However, there are few effective and largely available therapies for this devastating disease. In additon to advancing acute reperfusion therapies, there is a need to develop treatments aimed to promote repair and regeneration of brain tissue damaged by ischemia (neurorecovery)(1,2,3). Therapeutic angiogenesis and vasculogenesis represent novel approaches of regenerative medicine that may help in the cure of patients with acute ischemic stroke. Translation of our knowledge about these processes from the bench to bedside is still underway. Although angiogenesis (the sprouting of new blood vessels from pre-existing vascular structures) is likely to contribute to neurorepair, the finality of the angiogenic response in acute ischemic stroke has not been fully elucidated. The first therapeutic approach to angiogenesis after ischemic stroke would be the modulation of the endogenous angiogenic response. In this setting, early instauration of physical activity, statins, and peroxisome proliferator-activated receptor-γ agonists may enhance angiogenesis and neuroregeneration Statins have been shown to improve the functional outcome of patients after an ischemic stroke. We hypothesized that daily statin intake improves functional outcome after an acute ischemic stroke (4,5,6,7,8) Duplex sonography is the best noninvasive modality for investigation of possible carotid artery stenosis to evaluate the intema media thickness of carotid artery in patients of acute ischemic stroke before and after receiving high dose of statins to evaluate its effectiveness in management and appropriate dose of statins (9.10.11.12,13,14)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people have acute ischemic stroke', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* .patients.have acute ischemic stroke within 24 hours of onset. 2.patient not received intravenous thrombolysis or mechanical thrombectomy3.patients with no contraindications or hypersensitivity to statins\n\nExclusion Criteria:\n\n* 1\\. Patient received IV thrombolysis or underwent mechanical thrombectomy 2. patient have acute ischemic stroke with onset of more than 24 hours 3.patients have hypersestivty or contraindication to statin 4:patients refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT06371495', 'acronym': 'observation', 'briefTitle': 'Statins Role in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Statins in Acute Ischemic Stroke(Role of Statins in Reperfusion in Acute Stroke )', 'orgStudyIdInfo': {'id': 'statins in ischemic stroke'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group ABC', 'description': 'GroupA: recieve rosuvastatin 40mg', 'interventionNames': ['Drug: rosuvastatin']}, {'label': 'Group B', 'description': 'Group B :recive rosuvastatin20', 'interventionNames': ['Drug: rosuvastatin']}], 'interventions': [{'name': 'rosuvastatin', 'type': 'DRUG', 'otherNames': ['ststins'], 'description': 'Stude include three groupsof people GroupA: recieve rosuvastatin 40mg Group B :recive rosuvastatin 20mg Group C: recive placebo 2- Follow up will be done using NIHSS at the onset and modified Rankin scale at the onset and after 1 month and 3 months of the onset.\n\n3- Carotid duplex will be done at the onset and after 1 month and 3 months of the onset.', 'armGroupLabels': ['Group ABC', 'Group B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Heba Mohamed Sedeq', 'investigatorAffiliation': 'Assiut University'}}}}