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CompletedNCT01790997Updated Jun 4, 2014

Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

A Phase 3 interventional study of DLBS1033 and Aspirin in Acute Ischemic Stroke, sponsored by Dexa Medica Group. Completed at 1 site in Indonesia. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-06-04.

Sponsored by Dexa Medica Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Ischemic Stroke

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Keywords

  • DLBS1033
  • Lumbrokinase
  • Acute ischemic stroke
  • Bleeding profile
  • Clinical outcome
  • Aspirin
  • Clopidogrel
03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's enrollment of 126 is close to the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Dexa Medica Group is the lead sponsor of 41 studies on the registry; none are open to participants now.

Browse Dexa Medica Group studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    Treatment I

    1 tablet of DLBS1033 490 mg thrice daily, after meal

    Drug: DLBS1033

  • Active comparator
    Treatment II

    1 tablet of aspirin 80 mg once daily, after meal

    Drug: Aspirin

  • Active comparator
    Treatment III

    1 tablet of clopidogrel 75 mg once daily, after meal

    Drug: Clopidogrel

Interventions

  • DrugDLBS1033

    1 tablet of DLBS1033 490 mg thrice daily, after meal

  • DrugAspirin

    1 tablet of aspirin 80 mg once daily, after meal

  • DrugClopidogrel

    1 tablet of clopidogrel 75 mg once daily, after meal

06

What researchers measure

Primary outcomes

  1. 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

  1. Change in PT

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

    Time frame: 3 Months

  2. Change in aPTT

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

    Time frame: 3 Months

  3. Change in Gadjah Mada Stroke Scale

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

    Time frame: 3 Months

  4. Change in Barthel Index

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

    Time frame: 3 Months

07

Study locations

1 site
  • Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital
    Yogyakarta, Special Region of Yogyakarta 55281, Indonesia
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2012, a primary completion of Nov 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2013
First posted
Feb 13, 2013
Start
May 2012
Primary completionActual
Nov 2013
CompletionActual
Dec 2013
Last update
Jun 4, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01790997
Lead sponsor
Dexa Medica Group
Responsible party
Sponsor
First posted
Feb 13, 2013
Start date
May 2012
Primary completion
Nov 2013
Completion
Dec 2013
Last update
Jun 4, 2014

Study contacts

Ismail Setyopranoto, dr., SpS(K)
principal investigator · Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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