Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

Dexa Medica Group126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

126

Conditions

Acute Ischemic Stroke

Interventions

DLBS1033DRUG

1 tablet of DLBS1033 490 mg thrice daily, after meal

AspirinDRUG

1 tablet of aspirin 80 mg once daily, after meal

ClopidogrelDRUG

1 tablet of clopidogrel 75 mg once daily, after meal

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital

Yogyakarta, Jogjakarta, Indonesia

Outcomes

Primary Outcomes

Change in INR value

Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)

Time frame: 3 Months

Secondary Outcomes

Change in PT

Change in PT (prothrombin time) from baseline to end of study (Month 3rd)

Time frame: 3 Months

Change in aPTT

Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd)

Time frame: 3 Months

Change in Gadjah Mada Stroke Scale

Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd)

Time frame: 3 Months

Change in Barthel Index

Change in Barthel Index from baseline to end of study (Month 3rd)

Time frame: 3 Months

Data from ClinicalTrials.gov

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