DLBS1033 for Acute Ischemic Stroke Patients "ADDLIST"

Recruiting

Phase 2/3 Results N/A

Trial Description

This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in acute ischemic stroke patients. It is hypothesized that the improvement in functional outcomes as measured by NIHSS and BI as well as the improvement in haemostatic parameters as measured by thrombocyte aggregation test (TAT), fibrinogen, and d-dimer in DLBS group will be significantly greater than those in the control group.

Detailed Description

Subjects in this study will be screened consecutively and eligible subjects will be randomized into two groups and receive the investigational drug, DLBS1033 at a dose of 490 mg three times daily or its placebo in addition to standard therapy for 28-days course of therapy. Standard therapy used in this study will consist of: aspirin 80 mg, simvastatin 20 mg, and vitamin B complex.
After hospital admission and diagnosis, patient will be handled as per acute ischemic stroke management in each study site. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study treatments. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline and 3, 7,14, and 28 days after study medication initiation; while safety examinations will be performed at the same time point, but 3 and 14 days after study medication initiation.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo 3 x 1 tablet, given everyday for 28 days of study period
  • DLBS1033 Drug
    Other Names: Disolf
    Intervention Desc: Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet
    ARM 1: Kind: Experimental
    Label: DLBS1033
    Description: DLBS1033 enteric-coated tablet 3 x 490 mg daily, given everyday for 28 days of study period

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement in NIHSS 3, 7, 14, and 28 days No
Primary Improvement in BI 3, 7, 14, and 28 days No
Secondary Improvement in TAT 3, 7, 14, and 28 days No
Secondary Improvement in fibrinogen level 3, 7, 14, and 28 days No
Secondary Improvement in d-dimer level 3, 7, 14, and 28 days No
Secondary Liver function 7 and 28 days Yes
Secondary Renal function 7 and 28 days Yes
Secondary Routine hematology 7 and 28 days Yes
Secondary Adverse events 1 - 28 days Yes
Primary National Institutes of Health Stroke Scale (NIHSS) 3, 7, 14, and 28 days after study medication No
Primary Barthel Index (BI) 3, 7, 14, and 28 days after study medication No
Secondary Thrombocyte Aggregation Test (TAT) 3, 7, 14, and 28 days after study medication No
Secondary Fibrinogen level 3, 7, 14, and 28 days after study medication No
Secondary D-dimer level 3, 7, 14, and 28 days after study medication No

Sponsors