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Maurizio Paciaroni, Birsen Ince, Bo Hu...
https://pubmed.ncbi.nlm.nih.gov/31867054Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID06551415
Dabigatran Versus Apixaban in Cerebral Venous Thrombosis, a Randomized Controlled Trial
Led by Kafrelsheikh University · Updated on 2024-08-13
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two blood-thinning medications, dabigatran and apixaban, for adults who have experienced their first cerebral venous thrombosis (CVT), a type of blood clot in the brain's veins. This randomized controlled trial compares these two treatments by measuring rates of clot recurrence, recovery outcomes, vein reopening, headache impact, cognitive function, and bleeding complications over six months. Participants are randomly assigned to receive either dabigatran 150 mg twice daily or apixaban 5 mg twice daily for six months. The study includes two groups of 100 patients each. Throughout the study, patients undergo clinical evaluations, brain imaging scans, blood tests, heart and carotid artery monitoring when needed, and cognitive and headache assessments at baseline and at 30, 90, and 180 days. During the trial, participants will be monitored for venous recanalization by day 180 and for any bleeding complications related to the medication. Researchers will also assess functional recovery using the Modified Rankin Scale, cognitive ability with the MoCA test, headache severity with HIT-6, and any recurrent blood clots or vascular events such as pulmonary embolism or heart attack. Safety and treatment-related side effects will be tracked through follow-up questionnaires, ensuring comprehensive monitoring over the full six-month period.
CONDITIONS
Brief Title
Dabigatran Versus Apixaban in Cerebral Venous Thrombosis
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 and above
- New diagnosis of symptomatic cerebral venous thrombosis confirmed by CT/CT venogram or MRI/MR venogram
- Ability to start treatment within 14 days of diagnosis
- Suitable for oral anticoagulation as judged by the treating clinician
- Ability to provide written informed consent or have a legally authorized representative provide consent
You will not qualify if you...
- Known antiphospholipid antibody syndrome with previous venous or arterial thrombosis
- Need for invasive procedures before starting oral anticoagulation (e.g., lumbar puncture, thrombectomy, hemicraniectomy)
- Unable to swallow due to decreased consciousness
- Severe kidney impairment (creatinine clearance less than 30 mL/min)
- Positive pregnancy test or currently breastfeeding
- Bleeding disorders or other reasons preventing anticoagulation
- Medical conditions requiring mandatory antiplatelet or anticoagulant use
- Use of strong CYP3A4 inducers or inhibitors
- Severe or life-threatening illnesses preventing improvement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Treatment
Duration - 6 months
Participants receive either Dabigatran 150 mg twice daily or Apixaban 5 mg twice daily for 6 months. Clinical assessments including history, NIHSS, MoCA, HIT-6, and mRS are performed at baseline, 30, 90, and 180 days. Routine blood tests and imaging are conducted as indicated.
4 visits (in-person) at baseline, 30, 90, and 180 days
Follow-up
Duration - Up to 6 months
Participants are monitored for safety outcomes including hemorrhagic complications and treatment-related adverse effects, as well as efficacy outcomes such as venous recanalization and recurrent venous thromboembolism, through 6 months after treatment initiation.
Visits coincide with treatment visits; additional follow-up questionnaires may be completed
Trial Site Locations
Total: 1 location
1
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt, 33511
Actively Recruiting
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Research Team
M
mohamed G. Zeinhom, MD
S
sherihan R. ahmed, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Dawn M Meyer, Karen C Albright, Teresa A Allison...
https://pubmed.ncbi.nlm.nih.gov/18190818