[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03347786":3,"trial-entities:NCT03347786":145,"trial-summary:NCT03347786":148},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":48,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":83,"locations":86,"central_contacts":141,"overall_officials":142,"references":143,"see_also_links":144},"NCT03347786","GNI_verapamil","Verapamil for Neuroprotection in Stroke","Intraarterial Verapamil for Neuroprotection in Ischemic Stroke","RECRUITING","2026-12","2025-01","2025-01-17","2017-04-20","Global Neurosciences Institute","OTHER",true,"The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.",null,[19],"Ischemic Stroke",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},60,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","10 mg Intra-arterial Verapamil","Intra-arterial delivery of verapamil following mechanical thrombectomy procedure will be administered at a randomized dose of 10 mg or 20 mg to consenting patients.",[35],"Verapamil 10 mg Treatment Group",{"type":31,"name":37,"description":33,"armGroupLabels":38},"20 mg Intra-arterial Verapamil",[39],"Verapamil 20 mg Treatment Group",[41,45],{"measure":42,"description":43,"timeFrame":44},"Number of Participants with Bleeding Complications","Bleeding Complications including: symptomatic intracerebral hemorrhage (sICH), and Hemorrhagic Transformation (HT)","3 months",{"measure":46,"description":47,"timeFrame":44},"Number of Participants with a Serious Adverse Event of Death","Death",[49,53,55],{"measure":50,"description":51,"timeFrame":52},"Functional Outcomes","Change in modified Rankin Scale (mRS) Score","30-days and 90-days",{"measure":50,"description":54,"timeFrame":52},"Change in National Institutes of Health Stroke Scale (NIHSS) Score",{"measure":56,"description":57,"timeFrame":58},"Neuroimaging","MRI\u002F CT Scan","180 Days, 365 Days","ALL","18 Years","80 Years",false,{"inclusion":64,"exclusion":73,"raw_text":82},[65,66,67,68,69,70,71,72],"Written informed consent","18 years of age and over","Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia","Candidate for mechanical thrombectomy procedure","Onset of symptoms less than 8 hours","Measurable neurologic deficit (NIHSS ≥4)","Willingness to follow up with rehabilitation therapy","Anticipated life expectancy of at least 3 months",[74,75,76,77,78,79,80,81],"Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)","Hepatic and\u002For renal insufficiency (LFT's\\>3× upper limit of normal; CrCl \\\u003C 30ml\u002Fmin)","Thrombocytopenia (platelet count \\\u003C75,000\u002Fmm3)","History of intolerance to verapamil","Previous functional disability (modified Rankin \\> 1)","Severe stroke (NIHSS\\>22)","Stuporous or comatose","Unlikely to be available for 90 day follow-up","Inclusion Criteria:\n\n* Written informed consent\n* 18 years of age and over\n* Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia\n* Candidate for mechanical thrombectomy procedure\n* Onset of symptoms less than 8 hours\n* Measurable neurologic deficit (NIHSS ≥4)\n* Willingness to follow up with rehabilitation therapy\n* Anticipated life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)\n* Hepatic and\u002For renal insufficiency (LFT's\\>3× upper limit of normal; CrCl \\\u003C 30ml\u002Fmin)\n* Thrombocytopenia (platelet count \\\u003C75,000\u002Fmm3)\n* History of intolerance to verapamil\n* Previous functional disability (modified Rankin \\> 1)\n* Severe stroke (NIHSS\\>22)\n* Stuporous or comatose\n* Unlikely to be available for 90 day follow-up",[84,85],"ADULT","OLDER_ADULT",[87,114,133],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":111},"AtlantiCare Regional Medical Center","Atlantic City","New Jersey","08401","United States",[94,99,102,104,107,109],{"name":95,"role":96,"phone":97,"email":98},"Rob Szapor, MBA, BSN, RN","CONTACT","609-345-4000","rszapor@atlanticare.org",{"name":100,"role":101},"Mandy J Binning, MD","PRINCIPAL_INVESTIGATOR",{"name":103,"role":101},"Erol Veznedaroglu, MD",{"name":105,"role":106},"Rudy Rahme, MD","SUB_INVESTIGATOR",{"name":108,"role":106},"Kenneth Liebman, MD",{"name":110,"role":106},"Zakaria Hakma, MD",{"lat":112,"lon":113},39.36415,-74.42306,{"facility":115,"status":116,"city":117,"state":118,"zip":119,"country":92,"contacts":120,"geoPoint":130},"St Mary Medical Center","NOT_YET_RECRUITING","Langhorne","Pennsylvania","19047",[121,125,126,127,128,129],{"name":122,"role":96,"phone":123,"email":124},"Mary Dawson, Research Manager","215-710-2000","Mary.Dawson@stmaryhealthcare.org",{"name":100,"role":101},{"name":103,"role":101},{"name":105,"role":106},{"name":108,"role":106},{"name":110,"role":106},{"lat":131,"lon":132},40.17455,-74.92267,{"facility":134,"status":135,"city":136,"state":118,"zip":137,"country":92,"geoPoint":138},"Crozer Chester Medical Center","COMPLETED","Upland","19013",{"lat":139,"lon":140},39.85261,-75.38269,[],[],[],[],{"nct_id":4,"conditions":146,"biomarkers":147},[19],[],{"nct_id":4,"found":15,"summary":149,"prompt_version":158},{"design":150,"status":151,"heading":6,"summary":152,"follow_up":153,"word_count":154,"commitments":155,"compensation":156,"drugs_mentioned":157},"This is an interventional study with a planned enrollment of 60 participants. Participants will be randomly assigned to receive either 10 mg or 20 mg of intra-arterial verapamil.","completed","This study is testing an experimental procedure using intra-arterial verapamil in people who have had an acute ischemic stroke. Verapamil is a drug that treats vasospasm (spasm of a blood vessel). Researchers want to see if giving 10 mg or 20 mg of verapamil directly into an artery after a mechanical thrombectomy (a procedure to remove a blood clot) is safe and how it affects stroke recovery. You may be able to join if you are 18 to 80 years old, have had a recent ischemic stroke, and are a candidate for mechanical thrombectomy. The study will look at bleeding complications and serious adverse events, including death, at 3 months to understand the safety of this treatment. The current recruitment status is unclear.","Participants will be followed for 3 months to monitor for bleeding complications and serious adverse events.",123,"Participants will receive intra-arterial verapamil following a mechanical thrombectomy procedure.","Not stated in the trial record.",[],"v2"]