Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy | NCT07746882

NCT07746882

Overview

NCT ID: NCT07746882
Lead Sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER
Official Title: Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy
Brief Summary: To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months.
Conditions: Stroke
Acute Ischemic Stroke
Interventions: Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Aug 15, 2026Estimated
Primary Completion Date: Aug 31, 2028Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age ≥18 years

Ischemic stroke patients with undetermined etiology, within 14 days of onset, with completed etiological assessment

At least one of the following:

Cortical or multi-territorial infarct

Recurrent stroke or stroke on antiplatelet therapy

Left atrial diameter >40 mm

Left ventricular dysfunction (EF 30-40% or regional wall motion abnormality)

Atrial premature beats >1500/24h

Exclusion Criteria:

Stenosis ≥50% in the responsible vessel or high-risk plaque

Identified cardioembolic source

PFO with planned closure

Malignancy

Indication for mandatory anticoagulation/antiplatelet therapy

Active bleeding (intracranial, subarachnoid, gastrointestinal, etc.)

History of intracranial hemorrhage

Current or recent gastrointestinal ulcer

Recent brain or spinal injury/surgery

Known or suspected vascular malformations or aneurysms

Severe renal impairment (CrCl <30 ml/min)

Liver disease with bleeding risk (Child-Pugh B or C)

Pregnancy or lactation

Other contraindications to anticoagulation

Study Plan

Study Type: Interventional
Phase: Phase 3
Enrollment: 680Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Min Lou, PhD, MDContact
lm99@zju.edu.cn

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