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ABACVT: Anticoagulation Plus Batroxobin for Acute Cerebral Venous Thrombosis
NCT07352358Phase 4
Key facts
- Status
- Recruiting
- Start
- Jan 2026
- Primary completion
- Jul 2028
- Countries
- 1
- Sponsor
- Xuanwu Hospital
- Modality
- Therapeutic Enzymes
- Drugs
- batroxobin
- Conditions
- Cerebral venous thrombosis (CVT)
01
Overview
Phase 4, randomised, triple-blind trial of batroxobin in Cerebral venous thrombosis (CVT) (2 arms), sponsored by Xuanwu Hospital. Primary endpoint: Proportion of patients achieving complete recanalization at 7 days. Started Jan 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedTriple-blind
batroxobin plus anticoagulation
Batroxobin (initial dose 10 BU, then 5 BU every other day) + Anticoagulation Agents (LMWH bridged to warfarin, rivaroxaban, or dabigatran).
standard anticoagulation treatment group
Anticoagulation Agents alone (LMWH bridged to warfarin, rivaroxaban, or dabigatran).
03
Who it enrols
Adults with neuroimaging-confirmed acute cerebral venous thrombosis within 30 days of symptom onset, excluding those with bleeding risks, recent surgery, severe organ dysfunction, or current use of anticoagulants/antiplatelets.
04
Endpoints
Primary
Proportion of patients achieving complete recanalization
Secondary
Proportion of patients achieving neurological improvement
Proportion of patients achieving neurological deterioration
Proportion of patients achieving functional improvement
Occurrence of CVT recurrence
Occurrence of other vascular events
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