A Phase 3 interventional study of Dabigatran Etexilate 150mg and Apixaban 5MG in Cerebral Venous Sinus Thrombosis, sponsored by Kafrelsheikh University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Kafrelsheikh University · Phase 3, Interventional, and Treatment
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 apixaban 5mg Bid were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral hemorrhagic complications
The investigators conducted a single-blinded randomized controlled trial between August 2021 and August 2024 after the ethics committee of the faculty of medicine at Kafr el-Sheik University approved it.
The investigators got written informed consent from all eligible patients or their first order of kin before randomization.
The study will be composed of 2 arms Dabigatran arm, which consisted of 100 patients who received 150 mg Bid dabigatran daily for 6 months, and the apixaban arm, consisting of 100 patients who received (5 mg Bid for 6 months),
Study Procedures:
Every patient in our study will undergo:
Clinical workup: History, clinical assessment, NIHSS, MoCA, HIT-6, and mRS were recorded at baseline and 30,90,180 days as a follow-up.
Detection of Risk Factors \& Profiles:
Echocardiography TTE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. 3- Carotid Duplex: carotid duplex in indicated patients.
4- ESR \& Lipid Profile\& liver functions: All will be tested routinely for all patients.
5- 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.
Primary End Point:
The 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.
30 studies on the registry are indexed under Intracranial Thrombosis; 12 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 13 interventional studies indexed under Intracranial Thrombosis.
Browse Intracranial Thrombosis studies →Kafrelsheikh University is the lead sponsor of 291 studies on the registry; 112 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
Drug: Dabigatran Etexilate 150mg
100 CVT patients will receive apixaban 5mg 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
Drug: Apixaban 5MG
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
Also known as: group A
100 CVT patients will receive apixaban 5mg 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.
Also known as: group B
The proportion of subjects who have partial or complete venous recanalization by Day 180
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
Time frame: 180 days
Rate of drug-related hemorrhagic complications
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.
Time frame: 180 days
value of Modified Rankin Scale (mRS) at six months
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.
Time frame: 6 months
value of HIT-6 score in each group after six months of treatment
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)
Time frame: 6 months
rate of drug adverse effects
Drug adverse effects: all non-hemorrhagic side effects related to the drugs of our study will be reported
Time frame: 6 months
The proportion of participants with recurrent venous thromboembolism
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
Time frame: 6 months
rate of composite pulmonary embolism, myocardial infarction, and death due to vascular events
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
Time frame: 6 months
Plan to share: No — All the data supporting this research's findings will be available from the corresponding author, Dr. Mohamed G. Zeinhom, upon reasonable request.
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Studies of the drugs tested here: Dabigatran · Apixaban