Clinical trial NCT06551415: Dabigatran Versus Apixaban in Cerebral Venous Thrombosis
Official title: Dabigatran Versus Apixaban in Cerebral Venous Thrombosis, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cerebral Venous Sinus Thrombosis
Keywords: apixaban,
cerebral venous thrombosis
Dabigatran
Egypt
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 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
Primary purpose: TREATMENT

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 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

Detailed description: 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.

• 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

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) before initiation of oral anticoagulation
3. Patient is unable to swallow due to a 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. The patient has a severe or fatal comorbid illness that will prevent improvement

Primary outcomes:
measure: The proportion of subjects who have partial or complete venous recanalization by Day 180
timeFrame: 180 days
measure: Rate of drug-related hemorrhagic complications
timeFrame: 180 days
Secondary outcomes:
measure: value of Modified Rankin Scale (mRS) at six months
timeFrame: 6 months
measure: value of HIT-6 score in each group after six months of treatment
timeFrame: 6 months
measure: rate of drug adverse effects
timeFrame: 6 months
measure: The proportion of participants with recurrent venous thromboembolism
timeFrame: 6 months
measure: rate of composite pulmonary embolism, myocardial infarction, and death due to vascular events
timeFrame: 6 months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr Elsheikh University Hospital
Study officials:
affiliation: neurology department kafr el-sheikh university
name: mohamed G. Zeinhom, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.