Trial | NCT01790997  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    126
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 Started
May 31
2012
Primary Completion
Nov 30
2013
Study Completion
Dec 31
2013
Last Update
Jun 04
2014
Estimate

Drug DLBS1033

1 tablet of DLBS1033 490 mg thrice daily, after meal

Drug Aspirin

1 tablet of aspirin 80 mg once daily, after meal

Drug Clopidogrel

1 tablet of clopidogrel 75 mg once daily, after meal

Treatment I Experimental

1 tablet of DLBS1033 490 mg thrice daily, after meal

Treatment II Active Comparator

1 tablet of aspirin 80 mg once daily, after meal

Treatment III Active Comparator

1 tablet of clopidogrel 75 mg once daily, after meal

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
No Results Posted