Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

Study Overview
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Brief Summary
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This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.

Detailed Description
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There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens : Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal Treatment II : 1 tablet of aspirin 80 mg once daily, after meal Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (Month 3rd). General condition of the subjects will be followed-up every month over three months of study medication. Physiotherapy will be provided to the subjects by the assigned Physiotherapist.

Official Title
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The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: DLBS1033
* Drug: Aspirin
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects aged 20-80 years old Having non-bleeding stroke in CT scan examination Having stroke attack onset ≤ 96 hours Living in 100 km from RSUP Dr Sardjito Jogjakarta Exclusion Criteria: Having recurrence stroke Having Transient Ischemic Attack (TIA) Have been regularly taking anti-aggregation agent Having intracerebral and subarachnoid bleeding stroke Subjects and their family do not know when the stroke symptoms appeared History of haemostasis disorder History of or will have surgery within 6 months prior to screening

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment I<br>1 tablet of DLBS1033 490 mg thrice daily, after meal | Drug: DLBS1033<br>* 1 tablet of DLBS1033 490 mg thrice daily, after meal<br>|
| Active Comparator: Treatment II<br>1 tablet of aspirin 80 mg once daily, after meal | Drug: Aspirin<br>* 1 tablet of aspirin 80 mg once daily, after meal<br>|
| Active Comparator: Treatment III<br>1 tablet of clopidogrel 75 mg once daily, after meal | Drug: Clopidogrel<br>* 1 tablet of clopidogrel 75 mg once daily, after meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in INR value | Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd) | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PT | Change in PT (prothrombin time) from baseline to end of study (Month 3rd) | 3 Months | 
| Change in aPTT | Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd) | 3 Months | 
| Change in Gadjah Mada Stroke Scale | Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd) | 3 Months | 
| Change in Barthel Index | Change in Barthel Index from baseline to end of study (Month 3rd) | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBS1033, Lumbrokinase, Acute ischemic stroke, Bleeding profile, Clinical outcome, Aspirin, Clopidogrel