临床研究杂志

The Use of MLC901 in Combination with Anticoagulant among an Eastern European Cohort - Real World Data from NeuroAiD Safe Treatment Registry(NeST Registry)

Abstract

Anita Arsovska

Objectives: The efficacy and safety of NeuroAiD™ is well-established in patients with ischemic stroke in the acute and chronic phase. It is an addon treatment to standard therapies and there were no reports of major interactions. However, there is currently no data on the use of NeuroAiDTM in combination with anticoagulants. We aimed to determine the safety of using MLC901 (NeuroAiD II) with anticoagulants among patients in the Eastern European Cohort.

Methods: We performed a subgroup analysis of patients enrolled in the NeuroAiD Safe Treatment Registry (NeST). Patient who were given anticoagulants were included. Data collected were baseline demographics, diagnosis, concomitant medications and adverse events.

Results: A total of 98 patients were included. There were 48 female (49%), median age 64 years IQR (50,71), baseline median NIHSS 16, IQR (11,20), median mRS 4, IQR (3.25,5). Diagnoses included: Ischemic Stroke -80%, Traumatic Brain Injury - 7%, Cerebral Venous Thrombosis - 3%, Global hypoxic encephalopathy - (2%), Venous infarct - 1 %, AV Malformation - 1%, Meningoencephalitis - 1%. Risk factors were: hypertension - 72%, diabetes mellitus - 21% and hyperlipidaemia - 31%. The presence of cardiac disease was seen in 38% of which 24% had non-valvular atrial fibrillation. The concomitant anticoagulants were used in 98% of patients and included: low-molecular-weight heparin (LMWH), direct acting oral anticoagulants (DOACs), and Vitamin K antagonist (VKA). Neither adverse events nor side effects were reported.

Conclusions: The study provides new evidence for the safe use of MLC901 when combined with anticoagulants in a real-world setting.