Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

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Dexa Medica

Status and phase

Completed
Phase 3

Conditions

Acute Ischemic Stroke

Treatments

Drug: DLBS1033
Drug: Clopidogrel
Drug: Aspirin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01790997
DLBS1033-UST-001.11

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

126 participants in 3 patient groups

Treatment I
Experimental group
Description:
1 tablet of DLBS1033 490 mg thrice daily, after meal
Treatment:
Drug: DLBS1033
Treatment II
Active Comparator group
Description:
1 tablet of aspirin 80 mg once daily, after meal
Treatment:
Drug: Aspirin
Treatment III
Active Comparator group
Description:
1 tablet of clopidogrel 75 mg once daily, after meal
Treatment:
Drug: Clopidogrel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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