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Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
DLBS1033
Aspirin
Clopidogrel
Sponsored by
Dexa Medica Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring DLBS1033, Lumbrokinase, Acute ischemic stroke, Bleeding profile, Clinical outcome, Aspirin, Clopidogrel

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Treatment I

Treatment II

Treatment III

Arm Description

1 tablet of DLBS1033 490 mg thrice daily, after meal

1 tablet of aspirin 80 mg once daily, after meal

1 tablet of clopidogrel 75 mg once daily, after meal

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2013
Last Updated
June 3, 2014
Sponsor
Dexa Medica Group
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1. Study Identification

Unique Protocol Identification Number
NCT01790997
Brief Title
Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke
Official Title
The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexa Medica Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
DLBS1033, Lumbrokinase, Acute ischemic stroke, Bleeding profile, Clinical outcome, Aspirin, Clopidogrel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment I
Arm Type
Experimental
Arm Description
1 tablet of DLBS1033 490 mg thrice daily, after meal
Arm Title
Treatment II
Arm Type
Active Comparator
Arm Description
1 tablet of aspirin 80 mg once daily, after meal
Arm Title
Treatment III
Arm Type
Active Comparator
Arm Description
1 tablet of clopidogrel 75 mg once daily, after meal
Intervention Type
Drug
Intervention Name(s)
DLBS1033
Intervention Description
1 tablet of DLBS1033 490 mg thrice daily, after meal
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
1 tablet of aspirin 80 mg once daily, after meal
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
1 tablet of clopidogrel 75 mg once daily, after meal
Primary Outcome Measure Information:
Title
Change in INR value
Description
Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Change in PT
Description
Change in PT (prothrombin time) from baseline to end of study (Month 3rd)
Time Frame
3 Months
Title
Change in aPTT
Description
Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd)
Time Frame
3 Months
Title
Change in Gadjah Mada Stroke Scale
Description
Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd)
Time Frame
3 Months
Title
Change in Barthel Index
Description
Change in Barthel Index from baseline to end of study (Month 3rd)
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail Setyopranoto, dr., SpS(K)
Organizational Affiliation
Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital
City
Yogyakarta
State/Province
Jogjakarta
ZIP/Postal Code
55281
Country
Indonesia

12. IPD Sharing Statement

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Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

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