Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis

NCT ID: NCT06551402

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-09
• Study Completion Date: 2026-11-01

Brief Summary

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

Detailed Description

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.

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 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

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 at 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.

• 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

Conditions

Cerebral Venous Sinus Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

dabigatran

100 CVT patients will receive dabigatran 150mg Bid for 6 months.

Group Type: ACTIVE_COMPARATOR

Dabigatran Etexilate 150mg

Intervention Type: DRUG

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.

rivaroxaban

100 CVT patients will receive Rivaroxaban 20mg daily for 6 months.

Group Type: ACTIVE_COMPARATOR

Rivaroxaban 20 MG Oral Tablet

Intervention Type: DRUG

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.

Interventions

Dabigatran Etexilate 150mg

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.

Intervention Type: DRUG

Rivaroxaban 20 MG Oral Tablet

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.

Intervention Type: DRUG

Other Intervention Names

group A; group B

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

1. The patient has known antiphospholipid antibody syndrome with a previous history of venous or arterial thrombosis

2. The patient is anticipated to require invasive procedures (e.g., lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation

3. Patient is unable to swallow due to depressed level of consciousness

4. Impaired renal function (i.e., CrCl < 30 mL/min using CockroftGault equation)

5. Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive

6. Breastfeeding at the time of randomization

7. Bleeding diathesis or other contraindication to anticoagulation

8. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use

9. Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)

10. Patient has a severe or fatal comorbid illness that will prevent improvement

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed G. zeinhom, MD

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mohamed G. Zeinhom, MD

Role: PRINCIPAL_INVESTIGATOR

neurology department kafr el-sheikh university

Locations

Kafr Elsheikh University Hospital

Kafr ash Shaykh, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

mohamed G. Zeinhom, MD

Role: CONTACT

mohamed_gomaa@med.kfs.edu.eg

2001009606828

sherihan R. ahmed, MD

Role: CONTACT

sherihan_rezq@med.kfs.edu.eg

2001113432342

Facility Contacts

mohamed G. Zeinhom, MD

Role: primary

mohamed_gomaa@med.kfs.edu.eg

2001009606828

sherihan R. ahmed, MD

Role: backup

sherihan_rezq@med.kfs.edu.eg

2001007481842

References

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.

Reference Type: BACKGROUND

PMID: 31867054 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18190818 (View on PubMed)

Other Identifiers

1012019

Identifier Type: -

Identifier Source: org_study_id