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Completed

NCT Number: NCT01790997

Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DLBS1033

Drug

1 tablet of DLBS1033 490 mg thrice daily, after meal

Aspirin

Drug

1 tablet of aspirin 80 mg once daily, after meal

clopidogrel

Drug

1 tablet of clopidogrel 75 mg once daily, after meal

Primary outcomes

  1. Change in INR value

    Time frame: 3 Months

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

Secondary outcomes

  1. Change in PT

    Time frame: 3 Months

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

  2. Change in aPTT

    Time frame: 3 Months

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

  3. Change in Gadjah Mada Stroke Scale

    Time frame: 3 Months

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

  4. Change in Barthel Index

    Time frame: 3 Months

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

Sponsors and collaborators

Lead sponsor

Dexa Medica Group

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2013
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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