NCT06339411

Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights

Not yet recruiting EARLY_PHASE1 Last updated 2 April 2024

What this trial tests

EARLY_PHASE1 trial testing Cerebrolysin in Acute Ischemic Stroke in 100 participants. Not yet recruiting.

Timeline

1 May 2024

Primary endpoint
31 December 2026

31 July 2027

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	EARLY_PHASE1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	1 May 2024
Primary completion	31 December 2026
Estimated completion	31 July 2027

Drugs / interventions tested

• Cerebrolysin — full drug profile →

Conditions studied

• Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

Chang Gung Memorial Hospital

Who can join

18 and older, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Stroke is a leading cause of mortality and disability globally, with acute ischemic strokes(AIS) due to Large Vessel Occlusion (LVO) presenting significant treatment challenges. Mechanical thrombectomy (MT) has emerged as an effective intervention for AIS within an 8-hour window from symptom onset. However, the potential to extend this window up to 24 hours for select patients could revolutionize outcomes for those arriving late at comprehensive stroke centers. This study investigates the efficacy and safety of Cerebrolysin as an adjunct therapy to MT in extended time window and improving patient recovery.

Methods:

We conducted a multi-center, prospective, randomized study within the Chang Gung Memorial Hospital system in Taiwan, targeting 100 AIS patients eligible for MT beyond the traditional 8-hour window. Participants were randomized to receive either standard care or Cerebrolysin post-MT, initiated within 24 hours of stroke onset and continued for 14 days. The study assessed neurological, neuropsychological, and biomarker outcomes at multiple time points post-stroke to evaluate the effects of Cerebrolysin on recovery.

Results:

The primary outcome will measure the proportion of patients achieving favorable functional outcomes (modified Rankin Scale 0-2) at 90 days. Secondary outcomes include the impact of Cerebrolysin on secondary hemorrhagic transformation, brain edema, mortality rates, and quality of life. The study aims to provide comprehensive data on the benefits of adding Cerebrolysin to the standard post-MT care, focusing on its potential to protect against reperfusion injuries and maintain blood-brain barrier integrity.

Conclusion:

By evaluating the role of Cerebrolysin in conjunction with MT, this study aims to extend the therapeutic window for AIS treatment, offering hope for improved outcomes for patients who would otherwise be ineligible for current reperfusion therapies. The findings may pave the way for new guidelines in stroke management, emphasizing the importance of integrated care approaches in enhancing patient recovery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.