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The efficacy and safety of new oral anticoagulant on patients with symptomatic intracranial atherosclerotic stenosis

The efficacy and safety of new oral anticoagulant on patients with symptomatic intracranial atherosclerotic stenosis

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-17012503
Enrollment
Unknown
Registered
2017-08-29
Start date
2017-08-30
Completion date
Unknown
Last updated
2017-09-04

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

Conditions

symptomatic intracranial atherosclerotic stenosis

Interventions

trial group:basic treatment and new oral anticoagulant therapy
control group: basic treatment and customary antiplatelet therapy

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged from 40 to 80 years; 2. Intracranial large artery(internal carotid artery, middle cerebral artery, vertebral artery or basilar artery) stenosis rate is not less than 50% confirmed by radiographic, and this stenosis leds to recent (within 3 months) TIA or nondisabling cerebral infarction (modified Rankin score=3 points); 3. Neurologic impairment score(NIHSS)=16 points; 4. The conventional standard antiplatelet therapy (sICAS patients were treated with long-term application of aspirin or clopidogrel after treatment of clopidogrel combined with aspirin for 90d) had a poor effect (acute cerebral infarction still progresses after 1 weeks, TIA still occurs after 1 weeks, or IS/TIA recurred after that); 5. The patient himself or his legal representative has signed the informed consent before the start of this study;

Exclusion criteria

Exclusion criteria: 1. Patients with intracranial hemorrhagic disease confirmed by head CT; 2. Patients with cardioembolism; 3. Patients with severe Conscious disorder, with socre of 1a of NIHSS>1 points, with dysphagia or can't take capsule orally; 4. Patient has received thrombolysis or endovascular treatment after the onset of the disease; 5. Patients with brain trauma, brain tumor, malignant tumor, blood disease, liver dysfunction (more than 2 times the upper limit of normal value), renal function (creatinine values more than 1.5 times the upper limit of normal value) or have other serious systemic disease or with life expectancy of less than 3 months; 6. Patients with hemorrhagic tendency; 7. Patients with unmanageablet hypertension or hypotension, or severe hyperglycemia or hypoglycemia; 8. Patients with allergic history of test drug or contrast drug; 9. Patients are during pregnancy or lactation or have the possibility or plan to get pregnant; 10. The researchers believe there are other unsuitable conditions.

Design outcomes

Primary

MeasureTime frame
ischemic stroke recurrence;hemorrhagic stroke;cardiovascular death;post stroke disability;

Secondary

MeasureTime frame
other cardiovascular events;vascular related procedures and procedures;systemic thromboembolic events;

Countries

China

Contacts

Public ContactFeng Juan

Shengjing Hospital of China Medical University

fengjuan99@hotmail.com+86 18940255288

Outcome results

None listed

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