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Compares treatment options for Cerebral Venous Sinus Thrombosis
Official title Dabigatran Versus Apixaban in Cerebral Venous Thrombosis
ClinicalTrials.gov ID: NCT06551415
What this study is testing
What is Dabigatran Etexilate 150mg?
Dabigatran Etexilate 150mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for cerebral venous sinus thrombosis.
Also referred to as group A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients aged 18 and above
- New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CT venogram or MRI/MR venogram
- Ability to randomize within 14 days of neuroimaging-confirmed diagnosis
- The treating clinician thinks that the patient is appropriate for oral anticoagulation as per the standard of care
- The patient or legally authorized representative can give written informed consent
You likely can't join if
- The patient has known antiphospholipid antibody syndrome with a previous history of venous or arterial thrombosis
- The patient is anticipated to require invasive procedures (e.g., lumbar puncture, thrombectomy, hemicraniectomy) before initiation of oral...
- Patient is unable to swallow due to a depressed level of consciousness
- Impaired renal function (i.e., CrCl \< 30 mL/min using CockroftGault equation)
- Pregnancy: if a woman is of childbearing potential, a urine or serum beta-human chorionic gonadotropin (β-hCG) test is positive
- Breastfeeding at the time of randomization
See the full eligibility criteria
- Patients aged 18 and above
- New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CT venogram or MRI/MR venogram
- Ability to randomize within 14 days of neuroimaging-confirmed diagnosis
- The treating clinician thinks that the patient is appropriate for oral anticoagulation as per the standard of care
- The patient or legally authorized representative can give written informed consent
- The patient has known antiphospholipid antibody syndrome with a previous history of venous or arterial thrombosis
- The patient is anticipated to require invasive procedures (e.g., lumbar puncture, thrombectomy, hemicraniectomy) before initiation of oral anticoagulation
- Patient is unable to swallow due to a depressed level of consciousness
- Impaired renal function (i.e., CrCl \< 30 mL/min using CockroftGault equation)
- Pregnancy: if a woman is of childbearing potential, a urine or serum beta-human chorionic gonadotropin (β-hCG) test is positive
- Breastfeeding at the time of randomization
- Bleeding diathesis or other contraindication to anticoagulation
- Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use
- Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of Dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)
- The patient has a severe or fatal comorbid illness that will prevent improvement
The study team makes the final eligibility decision.
Where it's taking place
- Kafr ash Shaykh, Egypt
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kafr ash Shaykh, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.