Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-08 @ 7:56 PM
Study NCT ID:
NCT04148105
Status:
TERMINATED
Last Update Posted:
2024-05-31
First Post:
2019-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D020301', 'term': 'Vasospasm, Intracranial'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077407', 'term': 'Cilostazol'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Insufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life Outcomes: Short-Form 12', 'timeFrame': 'Baseline, 1 month postoperatively, 3 month postoperatively, and 6 month postoperatively', 'description': 'Short-Form 12 is answered by the patient. On a scale of 0-100, a higher score means better overall physical and mental health.'}, {'measure': 'Modified Rankin Scale', 'timeFrame': 'Baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively', 'description': "The patient's clinical status is graded on a scale of 0-6. An increasing score means a worse functional outcome."}], 'primaryOutcomes': [{'measure': 'Delayed Cerebral Infarction', 'timeFrame': 'Baseline', 'description': 'Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions'}, {'measure': 'Delayed Cerebral Infarction', 'timeFrame': '1 week (+/- 2 days) postoperatively', 'description': 'Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions'}, {'measure': 'Delayed Cerebral Infarction', 'timeFrame': '1 month (+/- 7 days) postoperatively', 'description': 'Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions'}], 'secondaryOutcomes': [{'measure': 'Symptomatic Cerebral Vasospasm', 'timeFrame': 'At any point leading up to 14 days post-operation', 'description': 'Development of a new focal or global neurological deficit or deterioration of at least 2 points on the Glasgow Coma Scale which was not explained by initial hemorrhage, re-bleeding, hydrocephalus, surgical complications, fever, infections, or electrolyte or metabolic disturbances; regardless of cerebral infarctions or angiographic vasospasm on imaging'}, {'measure': 'Radiographic Vasospasm', 'timeFrame': 'Between 7-10 days postoperatively', 'description': 'Arterial narrowing not attributable to atherosclerosis, catheter-induced vasospasm, or vessel hypoplasia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delayed cerebral ischemia', 'Cerebral vasospasm', 'Cilostazol'], 'conditions': ['Aneurysmal Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '25272066', 'type': 'BACKGROUND', 'citation': "D'Souza S. Aneurysmal Subarachnoid Hemorrhage. J Neurosurg Anesthesiol. 2015 Jul;27(3):222-40. doi: 10.1097/ANA.0000000000000130."}, {'pmid': '25187783', 'type': 'BACKGROUND', 'citation': 'Dabus G, Nogueira RG. Current options for the management of aneurysmal subarachnoid hemorrhage-induced cerebral vasospasm: a comprehensive review of the literature. Interv Neurol. 2013 Oct;2(1):30-51. doi: 10.1159/000354755.'}, {'pmid': '6338383', 'type': 'BACKGROUND', 'citation': 'Allen GS, Ahn HS, Preziosi TJ, Battye R, Boone SC, Boone SC, Chou SN, Kelly DL, Weir BK, Crabbe RA, Lavik PJ, Rosenbloom SB, Dorsey FC, Ingram CR, Mellits DE, Bertsch LA, Boisvert DP, Hundley MB, Johnson RK, Strom JA, Transou CR. Cerebral arterial spasm--a controlled trial of nimodipine in patients with subarachnoid hemorrhage. N Engl J Med. 1983 Mar 17;308(11):619-24. doi: 10.1056/NEJM198303173081103.'}, {'pmid': '22556195', 'type': 'BACKGROUND', 'citation': 'Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson BG, Vespa P; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012 Jun;43(6):1711-37. doi: 10.1161/STR.0b013e3182587839. Epub 2012 May 3.'}, {'pmid': '8450326', 'type': 'BACKGROUND', 'citation': 'Haley EC Jr, Kassell NF, Torner JC. A randomized controlled trial of high-dose intravenous nicardipine in aneurysmal subarachnoid hemorrhage. A report of the Cooperative Aneurysm Study. J Neurosurg. 1993 Apr;78(4):537-47. doi: 10.3171/jns.1993.78.4.0537.'}, {'pmid': '27160932', 'type': 'BACKGROUND', 'citation': 'Veldeman M, Hollig A, Clusmann H, Stevanovic A, Rossaint R, Coburn M. Delayed cerebral ischaemia prevention and treatment after aneurysmal subarachnoid haemorrhage: a systematic review. Br J Anaesth. 2016 Jul;117(1):17-40. doi: 10.1093/bja/aew095. Epub 2016 May 8.'}, {'pmid': '23039152', 'type': 'BACKGROUND', 'citation': 'Senbokuya N, Kinouchi H, Kanemaru K, Ohashi Y, Fukamachi A, Yagi S, Shimizu T, Furuya K, Uchida M, Takeuchi N, Nakano S, Koizumi H, Kobayashi C, Fukasawa I, Takahashi T, Kuroda K, Nishiyama Y, Yoshioka H, Horikoshi T. Effects of cilostazol on cerebral vasospasm after aneurysmal subarachnoid hemorrhage: a multicenter prospective, randomized, open-label blinded end point trial. J Neurosurg. 2013 Jan;118(1):121-30. doi: 10.3171/2012.9.JNS12492. Epub 2012 Oct 5.'}, {'pmid': '1545249', 'type': 'BACKGROUND', 'citation': 'Shibuya M, Suzuki Y, Sugita K, Saito I, Sasaki T, Takakura K, Nagata I, Kikuchi H, Takemae T, Hidaka H, et al. Effect of AT877 on cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Results of a prospective placebo-controlled double-blind trial. J Neurosurg. 1992 Apr;76(4):571-7. doi: 10.3171/jns.1992.76.4.0571.'}, {'pmid': '15273542', 'type': 'BACKGROUND', 'citation': 'Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.'}, {'pmid': '3964855', 'type': 'BACKGROUND', 'citation': 'Voldby B, Enevoldsen EM, Jensen FT. Regional CBF, intraventricular pressure, and cerebral metabolism in patients with ruptured intracranial aneurysms. J Neurosurg. 1985 Jan;62(1):48-58. doi: 10.3171/jns.1985.62.1.0048.'}, {'pmid': '4136544', 'type': 'BACKGROUND', 'citation': 'Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.'}, {'pmid': '19359629', 'type': 'BACKGROUND', 'citation': 'Frontera JA, Fernandez A, Schmidt JM, Claassen J, Wartenberg KE, Badjatia N, Connolly ES, Mayer SA. Defining vasospasm after subarachnoid hemorrhage: what is the most clinically relevant definition? Stroke. 2009 Jun;40(6):1963-8. doi: 10.1161/STROKEAHA.108.544700. Epub 2009 Apr 9.'}, {'pmid': '22438522', 'type': 'BACKGROUND', 'citation': 'Zannad F, Gattis Stough W, McMurray JJ, Remme WJ, Pitt B, Borer JS, Geller NL, Pocock SJ. When to stop a clinical trial early for benefit: lessons learned and future approaches. Circ Heart Fail. 2012 Mar 1;5(2):294-302. doi: 10.1161/CIRCHEARTFAILURE.111.965707. No abstract available.'}, {'pmid': '19550060', 'type': 'BACKGROUND', 'citation': 'Puri KS, Suresh KR, Gogtay NJ, Thatte UM. Declaration of Helsinki, 2008: implications for stakeholders in research. J Postgrad Med. 2009 Apr-Jun;55(2):131-4. doi: 10.4103/0022-3859.52846.'}, {'type': 'BACKGROUND', 'citation': 'Abraham J. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. In: Brouder A, Tietje C, eds. Handbook of Transnational Economic Governance Regimes. Brill 2009. 1041-54. doi:10.1163/ej.9789004163300.i-1081.897'}, {'pmid': '33020083', 'type': 'DERIVED', 'citation': 'Dawley T, Claus CF, Tong D, Rajamand S, Sigler D, Bahoura M, Garmo L, Soo TM, Kelkar P, Richards B. Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol. BMJ Open. 2020 Oct 5;10(10):e036217. doi: 10.1136/bmjopen-2019-036217.'}]}, 'descriptionModule': {'briefSummary': 'The investigators seek to demonstrate that the combined use of cilostazol and nimodipine will significantly decrease the rate of delayed cerebral infarction and cerebral vasospasm after cerebrovascular intervention when compared to nimodipine alone.', 'detailedDescription': 'This research study is for people who have a brain hemorrhage, due to a ruptured aneurysm. Adding the drug cilostazol to the standard care may improve outcomes after surgery. The blood within the brain following aneurysmal hemorrhage can have harmful effects on the blood vessels causing them to narrow and thus decrease blood flow; this process is called vasospasm. Decreased blood flow in the brain can lead to more damage. Delayed cerebral ischemia is a complication which is believed to be a consequence of reduced blood flow to the brain following this type of hemorrhage. Cilostazol opens blood vessels and reduces the formation of blood clots. The standard treatment of these hemorrhages currently involves the use of nimodipine which also relaxes blood vessels and allows blood to flow more freely. The combination of these two drugs cilostazol and nimodipine may improve neurologic outcomes after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Anterior circulation aneurysm\n* Patients who have undergone surgical intervention\n* Absence of rebleeding or new intracranial hemorrhage noted on post-intervention CT scan\n* Consent for study participation\n\nExclusion Criteria:\n\n* Non-aneurysmal subarachnoid hemorrhage\n* Multiple ruptured aneurysms\n* Patients with congestive heart failure\n* Severe aneurysmal subarachnoid hemorrhage (Hunt Hess Grade V)\n* Active pathological bleeding\n* Allergy to cilostazol\n* Positive pregnancy test\n* Coagulopathy not caused by anti-coagulant use\n* History of hemorrhagic complications (gastrointestinal bleeding, etc)\n* Uncontrolled or severe comorbidity that would qualify as an absolute contraindication for cilostazol\n* Patients requiring anticoagulant/antiplatelet treatment following intervention (e.g. stent-assisted coiling or flow-diverting stent obliteration of aneurysm)'}, 'identificationModule': {'nctId': 'NCT04148105', 'briefTitle': 'Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Efficacy and Safety of Cilostazol-Nimodipine Combined Therapy on Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage (aSAH): A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '1072359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Implement standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Administer 100 mg cilostazol, twice daily for 14 days. In addition, implement the standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days, and the standard aneurysmal subarachnoid treatment pathway.', 'interventionNames': ['Drug: Cilostazol 100 MG']}], 'interventions': [{'name': 'Cilostazol 100 MG', 'type': 'DRUG', 'description': 'The addition of 100 mg cilostazol, twice daily for 14 days, to the standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ascension Providence Hospital', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}], 'overallOfficials': [{'name': 'Boyd Richards, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Div of Neurosurgery Ascension Providence Hospital MSU College of Human Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification will be made available following publication upon request at the discretion of the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}