Benefits and Risks of Clopidogrel vs. Aspirin Monotherapy after Recent Ischemic Stroke: A Systematic Review and Meta-Analysis.
Maurizio Paciaroni, Birsen Ince, Bo Hu...
https://pubmed.ncbi.nlm.nih.gov/31867054Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID06551402
Dabigatran Versus Rivaroxaban 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 drugs, dabigatran and rivaroxaban, for treating patients who have had their first cerebral venous thrombosis. This randomized controlled trial aims to compare how well a 150 mg twice daily dose of dabigatran works versus a 20 mg daily dose of rivaroxaban. The study will assess outcomes such as rates of recurrent venous thromboembolism, brain vein reopening, neurological function, and bleeding complications. The trial includes two groups of 100 patients each. One group receives dabigatran 150 mg twice daily, while the other takes rivaroxaban 20 mg once daily, both for six months. Participants will undergo clinical evaluations, brain scans, heart monitoring, blood tests, and neurological assessments at the start and at 30, 90, and 180 days. Imaging will be done at baseline and after six months, with urgent scans if clinical worsening occurs. Participants will be closely followed through interviews and questionnaires to measure brain function, headache impact, bleeding events, and other side effects. The main outcomes include the proportion of patients with partial or complete reopening of brain veins and the rate of bleeding complications by 180 days. Additional measures include neurological recovery, recurrent clots, and vascular events. Safety and treatment effects will be monitored throughout the study, which runs from August 2024 to November 2026.
CONDITIONS
Brief Title
Dabigatran Versus Rivaroxaban 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 oral anticoagulation within 14 days of diagnosis
- Treating clinician agrees oral anticoagulation is appropriate
- Patient or legally authorized representative can give written informed consent
You will not qualify if you...
- Known antiphospholipid antibody syndrome with prior venous or arterial thrombosis
- Anticipated need for invasive procedures before starting oral anticoagulation
- Unable to swallow due to decreased consciousness
- Impaired kidney function with creatinine clearance below 30 mL/min
- Pregnancy or positive pregnancy test in women of childbearing potential
- Breastfeeding at time of randomization
- Bleeding disorders or other contraindications to anticoagulation
- Medical conditions requiring mandatory antiplatelet or anticoagulant use
- Use of strong CYP3A4 inducers or inhibitors
- Severe or fatal illness 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)
Treatment
Duration - 6 months
Participants receive either dabigatran 150mg twice daily or rivaroxaban 20mg once daily for 6 months.
Visits at baseline, and at 30, 90, and 180 days for clinical assessments and questionnaires
Follow-up
Duration - Up to 180 days after treatment start (overlaps with treatment duration)
Participants are monitored for treatment outcomes including venous recanalization, safety, and adverse events after completing 6 months of treatment.
Visits at 30, 90, and 180 days for follow-up assessments
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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Published Research Related To This Trial
LOAD: a pilot study of the safety of loading of aspirin and clopidogrel in acute ischemic stroke and transient ischemic attack.
Dawn M Meyer, Karen C Albright, Teresa A Allison...
https://pubmed.ncbi.nlm.nih.gov/18190818