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Safety and Efficacy of Levosimendan for Acute Ischemic Stroke: A Randomized Controlled Clinical Trial

Safety and Efficacy of Levosimendan for Acute Ischemic Stroke: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110769
Enrollment
Unknown
Registered
2025-10-20
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

ischemic stroke

Interventions

Experimental Group :Levosimendan in addition to standard therapy

Sponsors

the First Hospital of Jilin University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. age >= 18 years and gender; 2. a definitive clinical diagnosis of acute ischaemic stroke with an NIHSS score of >=6, =2; 3. pre-morbidity mRS score <= 1; 4. patient or immediate family able and willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients receiving emergency reperfusion therapy (including intravenous thrombolysis and mechanical thrombolysis); 2. history of intracranial haemorrhagic disease confirmed by imaging; 3. Accompanied by seizures; 4. cardiac disease: diagnosis of acute coronary syndrome within 30 days prior to onset, severe ventricular outflow tract obstruction disease (e.g., hypertrophic or restrictive cardiomyopathy, severe cardiac valvular disease) clearly defined by cardiac ultrasound, and history of tip-twisting ventricular tachycardia; 5. Use of cardiotonic or antihypertensive drugs (milrinone, digitalis, dobutamine, etc.) within 3 days prior to onset of symptoms; use of levosimendan within 30 days prior to onset of symptoms; and use of cerebral vasodilators of the calcium antagonist class or the prostaglandin class after onset of symptoms (e.g., nimodipine, prostaglandins, fasudil, beclomethasone sodium, etc.); 6. Baseline systolic blood pressure =200 mmHg or diastolic blood pressure >=120 mmHg after drug control, and baseline heart rate >=120 beats/minute; 7. serum potassium < 3.5 mmol/l prior to drug initiation; 8. severe hepatic or renal insufficiency; 9. patients with a life expectancy of less than 3 months, pregnant or lactating women, or patients who are otherwise unable to complete the study; 10. those who are participating in other clinical studies or have participated in other clinical studies within 3 months prior to enrolment; 11. Any other circumstances that the investigator considers unsuitable for enrolment.

Design outcomes

Primary

MeasureTime frame
Proportion of 90+-7 day mRS scores 0-1;

Secondary

MeasureTime frame
NIHSS at discharge/7 days;Proportion of 90+-7 day mRS scores 0-2;Distribution of 90+-7 day mRS scores;Ultimate infarct volume.;Change in NIHSS scores before and after treatment.;

Countries

China

Contacts

Public ContactYang Ge

the First Hospital of Jilin University.

doctoryangyi@163.com+86 137 5666 1217

Outcome results

None listed

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