Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

Phase 3

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: DLBS1033; Drug: Aspirin; Drug: Clopidogrel

• Registration Number: NCT01790997
• Lead Sponsor: Dexa Medica Group

Brief Summary

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

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment I	DLBS1033	1 tablet of DLBS1033 490 mg thrice daily, after meal
Treatment II	Aspirin	1 tablet of aspirin 80 mg once daily, after meal
Treatment III	Clopidogrel	1 tablet of clopidogrel 75 mg once daily, after meal

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital; 🇮🇩 Yogyakarta, Jogjakarta, Indonesia