Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-01 @ 1:45 PM
Study NCT ID:
NCT06551402
Status:
RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020767', 'term': 'Intracranial Thrombosis'}], 'ancestors': [{'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'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': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "An independent statistician generated a blocked randomization sequence using computer-generated random numbers; in a one-to-one ratio, a specially trained and qualified nurse randomly assigned participants to receive Dabigatran or rivaroxaban. We prepared Sequentially numbered opaque sealed envelopes and 580 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 580. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened, and the patients were assigned to receive drugs A or B. Drug A included dabigatran, and Drug B included rivaroxaban. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We compared the efficacy and safety of a Dabigatran 150 mg Bid administered within 24 hours of randomization after having first-ever cerebral venous thrombosis compared to 20 mg rivaroxaban once daily were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral hemorrhagic complications'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-08-09', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects who have partial or complete venous recanalization by Day 180', 'timeFrame': '180 days', 'description': 'the investigators will perform magnetic resonance venography for all patients after 6 months to show if there is partial or complete recanalization of the affected venous sinus'}, {'measure': 'Rate of drug-related hemorrhagic complications', 'timeFrame': '180 days', 'description': 'the rate of drug hemorrhagic complications which was evaluated using the PLATO bleeding definition which classified hemorrhagic complications into three types as follows: Major bleeding which had one or more of the following criteria: fatal bleeding, intracranial, intrapericardial, bleeding associated with reduction of hemoglobin \\> 3-5 g/dl, bleeding required transfusion of two to four units whole blood or PRBCs, bleeding produced hypovolemic shock or severe hypotension that required pressor or surgery; Minor bleeding that required medical intervention to stop or treat bleeding: Minimal bleeding: any bleeding that did not require intervention or treatment such as bruising, bleeding gums, oozing from injection sites.'}], 'secondaryOutcomes': [{'measure': 'value of Modified Rankin Scale (mRS) at six months', 'timeFrame': '6 months', 'description': 'mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Its value ranges from 0 to 6; the lower the score, the better the stroke outcome. A favorable stroke outcome is considered with an mRS value equal to two or less.'}, {'measure': 'value of HIT-6 score in each group after six months of treatment', 'timeFrame': '6 months', 'description': 'The investigators assessed the absolute change in HIT6 score, the Headache Impact Test-6 (HIT-6) assessed the burden of headache in each group; the HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress, the patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often," or "always." These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. It has four impact grades: little-to-no impact (HIT-6 score: 36-49), moderate impact (HIT-6 score: 50-55), substantial impact (HIT-6 score: 56-59), and severe impact (HIT-6 score: 60-78)'}, {'measure': 'rate of drug adverse effects', 'timeFrame': '6 months', 'description': 'Drug adverse effects: all non-hemorrhagic side effects related to the drugs of our study will be reported'}, {'measure': 'The proportion of participants with recurrent venous thromboembolism', 'timeFrame': '6 months', 'description': 'The investigators will assess the proportion of participants with recurrent venous thromboembolism (any thrombosis at a new site, including CVT in a separate location from the index event) during 6 months of treatment'}, {'measure': 'rate of composite pulmonary embolism, myocardial infarction, and death due to vascular events', 'timeFrame': '6 months', 'description': 'The investigators will assess the proportion of participants with pulmonary embolism, myocardial infarction, and death due to vascular events at during 6 months of treatment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rivaroxaban', 'dabigatran', 'Egypt', 'cerebral venous thrombosis'], 'conditions': ['Cerebral Venous Sinus Thrombosis']}, 'referencesModule': {'references': [{'pmid': '31867054', 'type': 'BACKGROUND', 'citation': 'Paciaroni M, Ince B, Hu B, Jeng JS, Kutluk K, Liu L, Lou M, Parfenov V, Wong KSL, Zamani B, Paek D, Min Han J, Del Aguila M, Girotra S. Benefits and Risks of Clopidogrel vs. Aspirin Monotherapy after Recent Ischemic Stroke: A Systematic Review and Meta-Analysis. Cardiovasc Ther. 2019 Dec 1;2019:1607181. doi: 10.1155/2019/1607181. eCollection 2019.'}, {'pmid': '18190818', 'type': 'RESULT', 'citation': 'Meyer DM, Albright KC, Allison TA, Grotta JC. LOAD: a pilot study of the safety of loading of aspirin and clopidogrel in acute ischemic stroke and transient ischemic attack. J Stroke Cerebrovasc Dis. 2008 Jan-Feb;17(1):26-9. doi: 10.1016/j.jstrokecerebrovasdis.2007.09.006.'}]}, 'descriptionModule': {'briefSummary': 'Along with the current clinical trial, the efficacy and safety of a 150 mg Bid dabigatran administered within 24 hours of randomization after having first-ever cerebral venous thrombosis compared to 20 mg rivaroxaban were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral hemorrhagic complications', 'detailedDescription': 'The investigators conducted a single-blinded randomized controlled trial between August 2024 and September 2026 after the ethics committee of the faculty of medicine at Kafr el-Sheik University approved it.\n\nThe investigators got written informed consent from all eligible patients or their first order of kin before randomization.\n\nThe study will be composed of 2 arms rivaroxaban arm, which consisted of 100 patients who received 150 mg Bid dabigatran for 6 months, and the rivaroxaban arm, consisting of 100 patients who received 20mg rivaroxaban daily for 6 months\n\nStudy Procedures:\n\nEvery patient in our study will undergo:\n\nClinical workup: History, clinical assessment, NIHSS, MoCA, HIT-6, and mRS were recorded at baseline and at 30,90,180 days as a follow-up.\n\nDetection of Risk Factors \\& Profiles:\n\nEchocardiography TTE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. 3- Carotid Duplex: carotid duplex in indicated patients.\n\n4- ESR \\& Lipid Profile\\& liver functions: All will be tested routinely for all patients.\n\n5- Non-contrast CT brain and CTV on admission or MRI and MRV:, at baseline and after 6 months of treatment CT brain: Any patient with unexplained clinical deterioration at any time throughout his/her hospital stay will be urgently imaged by CT.\n\nPrimary End Point:\n\nThe primary efficacy outcome was the rate of Proportion of subjects with partial or complete venous recanalization by Day 180, and the primary safety outcome was the rate of drug hemorrhagic complications using the PLATO bleeding definition.\n\n• Secondary End Point: The secondary efficacy outcomes were to evaluate the rates of patients who achieved a favorable outcome with (mRS = 0-2) after one week and after 180 days in a face-to-face interview in the outpatient clinic, Proportion of subjects with recurrent venous thromboembolism (any thrombosis at a new site, including cerebral venous thrombosis in a separate location from the index event) at Day 180 or the end of anticoagulation, whichever is sooner, rates of a composite of pulmonary embolism, DVT, myocardial infarction, and death due to vascular events after 180 days of follow-up, the MoCA, HIT-6 by 180 days, while the secondary safety outcome was the rate of treatment-related adverse effects assessed by a follow-up questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-Patients aged 18 and above 2-New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CT venogram or MRI/MR venogram 3-Ability to randomize within 14 days of neuroimaging-confirmed diagnosis 4-The treating clinician thinks that the patient is appropriate for oral anticoagulation as per the standard of care 5-The patient or legally authorized representative can give written informed consent\n\nExclusion Criteria:\n\n1. The patient has known antiphospholipid antibody syndrome with a previous history of venous or arterial thrombosis\n2. The patient is anticipated to require invasive procedures (e.g., lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation\n3. Patient is unable to swallow due to depressed level of consciousness\n4. Impaired renal function (i.e., CrCl \\< 30 mL/min using CockroftGault equation)\n5. Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive\n6. Breastfeeding at the time of randomization\n7. Bleeding diathesis or other contraindication to anticoagulation\n8. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use\n9. Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)\n10. Patient has a severe or fatal comorbid illness that will prevent improvement'}, 'identificationModule': {'nctId': 'NCT06551402', 'briefTitle': 'Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1012019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dabigatran', 'description': '100 CVT patients will receive dabigatran 150mg Bid for 6 months.', 'interventionNames': ['Drug: Dabigatran Etexilate 150mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rivaroxaban', 'description': '100 CVT patients will receive Rivaroxaban 20mg daily for 6 months.', 'interventionNames': ['Drug: Rivaroxaban 20 MG Oral Tablet']}], 'interventions': [{'name': 'Dabigatran Etexilate 150mg', 'type': 'DRUG', 'otherNames': ['group A'], 'description': '100 CVT patients will receive dabigatran 150mg Bid for 6 months. We will assess the Proportion of subjects who have partial or complete venous recanalization by Day 180 the rate of drug hemorrhagic complications using the PLATO bleeding definition, and the rates of patients who achieved a favorable outcome with (mRS = 0-2) after one week and after 180 days in a face-to-face interview in the outpatient clinic, Proportion of subjects with recurrent venous thromboembolism (any thrombosis at a new site, including cerebral venous thrombosis in a separate location from the index event) at Day 180 or the end of anticoagulation, whichever is sooner, rates of a composite of pulmonary embolism, DVT, myocardial infarction, and death due to vascular events after 180 days of follow-up, the MoCA, HIT-6 by 180 days, the rate of treatment-related adverse effects assessed by a follow-up questionnaire.', 'armGroupLabels': ['dabigatran']}, {'name': 'Rivaroxaban 20 MG Oral Tablet', 'type': 'DRUG', 'otherNames': ['group B'], 'description': '100 CVT patients will receive Rivaroxaban 20mg daily for 6 months. We will assess the Proportion of subjects who have partial or complete venous recanalization by Day 180 the rate of drug hemorrhagic complications using the PLATO bleeding definition, and the rates of patients who achieved a favorable outcome with (mRS = 0-2) after one week and after 180 days in a face-to-face interview in the outpatient clinic, Proportion of subjects with recurrent venous thromboembolism (any thrombosis at a new site, including cerebral venous thrombosis in a separate location from the index event) at Day 180 or the end of anticoagulation, whichever is sooner, rates of a composite of pulmonary embolism, DVT, myocardial infarction, and death due to vascular events after 180 days of follow-up, the MoCA, HIT-6 by 180 days, the rate of treatment-related adverse effects assessed by a follow-up questionnaire.', 'armGroupLabels': ['rivaroxaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33511', 'city': 'Kafr ash Shaykh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mohamed G. Zeinhom, MD', 'role': 'CONTACT', 'email': 'mohamed_gomaa@med.kfs.edu.eg', 'phone': '2001009606828'}, {'name': 'sherihan R. ahmed, MD', 'role': 'CONTACT', 'email': 'sherihan_rezq@med.kfs.edu.eg', 'phone': '2001007481842'}], 'facility': 'Kafr Elsheikh University Hospital', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'mohamed G. Zeinhom, MD', 'role': 'CONTACT', 'email': 'mohamed_gomaa@med.kfs.edu.eg', 'phone': '2001009606828'}, {'name': 'sherihan R. ahmed, MD', 'role': 'CONTACT', 'email': 'sherihan_rezq@med.kfs.edu.eg', 'phone': '2001113432342'}], 'overallOfficials': [{'name': 'mohamed G. Zeinhom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'neurology department kafr el-sheikh university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "All the data supporting this research's findings will be available from the corresponding author, Dr. Mohamed G. Zeinhom, upon reasonable request."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohamed G. zeinhom, MD', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}