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PCSK9 Inhibitor in the Prevention of Early Neurological Deterioration of Acute Non-cardiogenic Ischemic Stroke (PIENDS): A Randomized, Parallel Controlled Clinical Study

PCSK9 Inhibitor in the Prevention of Early Neurological Deterioration of Acute Non-cardiogenic Ischemic Stroke (PIENDS): A Randomized, Parallel Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059445
Enrollment
Unknown
Registered
2022-04-29
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Non-cardiogenic Ischemic Stroke

Interventions

Group 1 :Subcutaneous injection of elouximab and Atorvastatin calcium tablets 40 mg orally
Group 2:Atorvastatin calcium tablets 40 mg orally

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18 <= age <= 80; 2. Patients with acute non-cardiogenic cerebral infarction within 24 hours of onset; 3. Unconscious disturbance; 4. For patients with the first onset or previous cerebral infarction patients without sequelae such as limb paralysis, the NIHSS score will not be affected; the previous mRS score is <= 1 point; 5. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Hemorrhagic stroke or mixed stroke; 2. Brain arteriovenous malformation or intracranial tumor; 3. Cardiogenic cerebrovascular disease; 4. Patients with uncontrollable severe hypertension, severe infection or abnormal liver function, renal insufficiency, blood system diseases with bleeding tendency, etc.; 5. History of previous cerebral hemorrhage; 6. Retinal hemorrhage or visceral hemorrhage within 30 days; 7. Patients who used PCSK9 inhibitors 3 months before the onset; 8. Patients with disturbance of consciousness; 9. Patients allergic to atorvastatin and PCSK9 inhibitors; 10. Patients who have had adverse reactions to atorvastatin in the past; 11. Pregnant or lactating women; 12. Those who are considered by the researchers to be inappropriate to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
early neurological deterioration;

Countries

China

Contacts

Public ContactXiaofei Ji

The First Affiliated Hospital of Dalian Medical University

jixiaofei1979@163.com+86 18098876273

Outcome results

None listed

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