HEMOSTASIS PROFILE AND CLINICAL OUTCOME OF ACUTE ISCHEMIC STROKE PATIENTS TREATED WITH ORAL LUMBROKINASE DLBS1033: A COMPARATIVE STUDY VERSUS ASPIRIN AND CLOPIDOGREL
Objectives: This clinical study was conducted to determine the hemostasis profile and clinical outcome of acute ischemic stroke patients treated with
DLBS1033 in comparison with aspirin or clopidogrel. DLBS1033 is a proprietary bioactive protein fraction derived from the earthworms (Lumbricus
rubellus) that possesses both fibrinolytic and antithrombotic properties.
Methods: This was a 3-arm, parallel, randomized, controlled, open-label, blinded-evaluation study involving 126 acute ischemic stroke patients. Each
subject received any of the following study medication within 96 hrs after the stroke onset: Aspirin 80 mg daily (Group 1), or clopidogrel 75 mg dail(Group 2), DLBS1033 490 mg 3 times daily (Group 3), for 90 days. Hemostasis parameters evaluated were prothrombin time (PT), activated partial
thromboplastin time (aPTT), and international normalized ratio (INR), while the clinical outcomes were measured using Gadjah Mada Stroke Scale
(SSGM) and Barthel index (BI).
Results: Baseline characteristics, including the hemostasis and clinical profiles, were comparable between groups. At the end of the study, PT, aPTTand INR values were not significantly different between groups, which were all within the normal ranges. There was a significant improvement of BI
as well as SSGM from baseline in each group. The improvement size of BI was found similar between groups (p=0.098). However, a significantly better
improvement of SSGM was observed in those received DLBS1033 (6.98Â±4.90; p=0.001 vs. aspirin [3.74Â±3.66], p=0.006 vs. clopidogrel [4.26Â±4.21]).
Conclusion: It was concluded that DLBS1033 provided a safe hemostasis profile (PT, aPTT, and INR) comparable to that of aspirin or clopidogrel in
ischemic stroke patients. Treatment with DLBS1033 improved clinical outcomes indicated by the BI and SSGM, and the improvement size of SSGM was
even better than that of aspirin or clopidogrel treatment.
Keywords: Acute ischemic stroke, Barthel index, DLBS1033, Hemostasis, Gadjah Mada Stroke Scale, Oral lumbrokinase.
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