C-REGS2—A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00098892%3A_____%2F25%3A10159514" target="_blank" >RIV/00098892:_____/25:10159514 - isvavai.cz</a>

Result on the web

<a href="https://journals.sagepub.com/doi/full/10.1177/17474930251375439" target="_blank" >https://journals.sagepub.com/doi/full/10.1177/17474930251375439</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1177/17474930251375439" target="_blank" >10.1177/17474930251375439</a>

Result language

angličtina

Original language name

C-REGS2—A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke

Original language description

Background: The main objective of the Cerebrolysin REGistry Study in Stroke 2 (C-REGS2) was to systematically record the routine clinical use of Cerebrolysin in patients with moderate ischemic stroke (IS) following the principles of a prospective controlled effectiveness study (CES) to compare its effectiveness in terms of functional recovery to patients treated with standard therapy alone. Methods: C-REGS2 used an open-label, prospective controlled comparative effectiveness design aligning with the Target Trial Emulation Framework (TTEF) and the GRACE principles for high-quality observational studies based on the principles of high-quality comparative effectiveness research (HQCER) to capture treatment effects in clinical practice. The study was conducted in 16 countries worldwide between April 2018 and April 2024. Moderate IS was defined as baseline NIH Stroke Scale (NIHSS) score 8–15. Treatment modalities and concomitant medications were according to local standards. The methodology included rigorous pre-specified analysis and tight risk-based centralized monitoring, to ensure minimal enrollment bias, maximize data quality and overall reliability of trial results. The compared patient groups were standardized using a restricted cohort design and non-parametric multilevel stratification following the Good Research for Comparative Effectiveness (GRACE) principles. The primary endpoint was ordinal analysis of the modified Rankin Scale (mRS) at 90 days after stroke onset. Secondary endpoints were the ordinal NIH Stroke Scale (NIHSS) at day 21 and 90 after stroke onset, the ordinal mRS at 21 days after IS, the proportion of patients with excellent recovery (mRS 0–1) as well as the proportion of patients with functional independence (mRS 0–2) at 90 days after stroke onset and the ordinal analysis of Montreal Cognitive Assessment (MoCA) scale at 90 days after IS. Results: Out of 1865 enrolled patients, the target population (TP) comprised 1769 patients (1021 Cerebrolysin-treated and 748 controls). The median NIHSS at baseline was 10.0. Median Cerebrolysin dose was 30 ml, median treatment duration was 10 days. Cerebrolysin was superior to standard therapy in the primary endpoint independently to prior thrombolysis (MW 0.6157; confidence interval (CI) 0.5910–0.6404; P &lt; 0.0001) as well as in all secondary endpoints: mRS at day 21 (MW 0.6065, 95% CI 0.5811–0.6319, P &lt; 0.0001), NIHSS at day 21 (MW 0.5792; 95% CI 0.5576–0.6008; P &lt; 0.0001) and NIHSS at day 90 (MW 0.5781; CI 0.5561–0.6002; P &lt; 0.0001). Additional pre-specified secondary endpoints (proportion of patients with excellent recovery and functional independence) showed moderate superiority for Cerebrolysin. The ordinal MoCA showed superiority for Cerebrolysin in the TP (MW 0.5530; CI 0.5282–0.5778; P &lt; 0.0001) with more pronounced effects in the subgroup with cognitive impairments at baseline (Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) ≥ 3.3). No differences in safety measures were recorded. The study is notable for its robust data integrity, with valid entries of 90.9% for the primary 90 day mRS assessment with multilevel case mix standardization and an overall dropout rate to the final visit of only 5.7%. Conclusion: The results of the C-REGS2 study showed the effectiveness and safety of Cerebrolysin treatment for moderate acute IS in real-world clinical practice.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30210 - Clinical neurology

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

International Journal of Stroke

ISSN

1747-4930

e-ISSN

1747-4949

Volume of the periodical

20

Issue of the periodical within the volume

9

Country of publishing house

GB - UNITED KINGDOM

Number of pages

11

Pages from-to

1060-1070

UT code for WoS article

001594438500012

EID of the result in the Scopus database

2-s2.0-105018790991