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Early intravenous Anticoagulation treatment in acute ischemic Stroke patients with severity intracranial arterial sTenosis or Atrial fibrillation

Early intravenous Anticoagulation treatment in acute ischemic Stroke patients with severity intracranial arterial sTenosis or Atrial fibrillation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022143
Enrollment
Unknown
Registered
2019-03-27
Start date
2019-04-10
Completion date
Unknown
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Part I (with severity intracranial arterial stenosis): antiplatelet group:1. Aspirin 300mg, QD+clopidogrel 75mg, QD in the first 24 hours. 2. 2. Aspirin 100mg, QD+clopidogrel 75mg, QD from 2-90 days.
Part I (with severity intracranial arterial stenosis): intravenous anticoagulation combined with antiplatelet group:1.intravenous argatroban 2.5mg/h within the first 48 hours and aspirin 100mg, QD
2. intravenous argatroban 2.5mg/h*4 hours, BID and aspirin 100mg, QD+clopidogrel 75mg, QD from 3-6 days
3.3. Aspirin 100mg, QD+clopidogrel 75mg, QD from 7-90 days.
Part II (with non-valvular atrial fibrillation): antiplatelet group:1.Aspirin 300mg, QD in the first 24 hours. 2.Aspirin 100mg, QD from 2-6 days. 3.Transition to oral anticoagulation therapy (new ora
Part II (with non-valvular atrial fibrillation): intravenous anticoagulation combined with antiplatelet group:1.intravenous argatroban 2.5mg/h within the first 48 hours and aspirin 100mg, QD. 2. intr

Sponsors

Department of Neurology, The Second Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Part I: Acute ischemic stroke with severity intracranial arterial stenosis: 1. Aged >18 years; 2. New acute ischemic stroke by MRI and with severity intracranial arterial stenosis defined as the stenosis =70% in Internal carotid artery, middle cerebral artery and anterior cerebral artery by MRA or CTA; 3. Admission NIHSS score =12; 4. Sudden onset of acute ischemic stroke with symptom onset to treatment (OTT) between 6 to 48 hours; 5. Partial anterior circulation syndrome according to OCSP classification; 6. First-ever stroke or history of stroke and pre-existing disability with mRS=1; 7. Signed (written) informed consent by the patient or the patient's legal representative and/or guardian. Part II: Acute ischemic stroke with Non-valvular Atrial fibrillation: 1. Aged >18 years; 2. New acute ischemic stroke by MRI and with Non-valvular Atrial fibrillation; 3. Admission NIHSS score =8; 4. Sudden onset of acute ischemic stroke with symptom onset to treatment (OTT) between 6 to 24 hours; 5. Partial anterior circulation syndrome according to OCSP classification; 6. First-ever stroke or history of stroke and pre-existing disability with mRS=1; 7. Signed (written) informed consent by the patient or the patient's legal representative and/or guardian.

Exclusion criteria

Exclusion criteria: Part I: Acute ischemic stroke with severity intracranial arterial stenosis 1. Hemorrhagic transformation after ischemic stroke; 2. Any anticoagulant treatment with in 7 days; 3. Patients given IV alteplase, mechanical thrombectomy or combine IV alteplase and mechanical thrombectomy treatment; 4. Unable to complete MRI; 5. Cardioembolic Stroke; 6. Known history of clinically significant hepatic dysfunction or liver disease, renal dysfunction; 7. Known history of hematologic or bleeding disease; 8. Non-atherosclerotic intracranial arterial stenosis, such as arterial dissection, arteritis; 9. Uncontrolled hypertension, SBP =180mmHg or DBP =110mmHg; 10. Admission INR>1.4, APTT>35s, Platelets1.4, APTT>35s, Platelets< 100x109/Lor glucose <2.7 mmol/L; 11. Patients with concurrent malignant tumor or undergoing anti-tumor therapy; 12. CT scan findings of hypoattenuation involving =1/3 of the MCA territory; 13. Active systemic hemorrhage, recent surgery or trauma or with in 30 days; 14. Pregnancy, lactation, or possible pregnancy and planned pregnancy; 15. Participated in other interventional clinical studies within 3 months or are participating in other intervention clinical studies; 16. The researchers considered the patients not suitable for this clinical study; 17. Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation.

Design outcomes

Primary

MeasureTime frame
the new ischemic lesion on follow-up MRI ;the new intracranial hemorrhage on follow-up MRI ;

Secondary

MeasureTime frame
early neurological deterioration;NIHSS score and mRS score;new ischemic stroke;composite of major vascular events including stroke, myocardial infarction, and vascular death;the functional outcome: mRS score;

Countries

China

Contacts

Public ContactYongjun Cao

Department of Neurology, the Second Affiliated Hospital of Soochow University

yongjuncao@126.com+86 13584877964

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026