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DLBS1033 for Acute Ischemic Stroke Patients (ADDLIST)

Primary Purpose

Acute Ischemic Stroke, Partial Anterior Circulation Infarct, Lacunar Anterior Circulation Infarct

Status

Active

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

DLBS1033

Placebo

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring DLBS1033, Acute ischemic stroke, NIHSS, Barthel Index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent from the patients or patients' legally acceptable representatives (must be obtained before any trial related activities).
Male or female subjects with age of >18 years at Screening.
Patients clinically diagnosed having acute ischemic stroke attack and confirmed by CT scan.
Patients with cerebral infarction subtypes of PACI or LACI as classified by Bamford criteria.
Patients with moderate condition based on National Institutes of Health Stroke Scale (NIHSS) score of 5-15.
Patients present at hospital and receiving first dose of study medication within 72 hours after the onset of the stroke symptoms.
Able to take oral medication.

Exclusion Criteria:

For females of childbearing potential: pregnancy and lactation period.
History of hemorrhagic stroke within the last 3 months.
Patients with seizure at the onset of stroke or with regular medication for seizure/epilepsy.
Current or regular use (within the last 1 month) of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.
Patients who have received tissue plasminogen activator (TPA) within 24 hours to Screening.
History of serious head injury within the last 3 months.
History of major surgery within the last 3 months.
Recent serious cardiovascular conditions, such as myocardial infarction and heart atrial fibrillation as demonstrated by electrocardiography (ECG).
History of congestive heart failure and aortic dissection.
Presence of severe renal and hepatic dysfunction, defined as serum creatinine level > 3x upper limit of normal (ULN) or history of hemodialysis, and any of serum ALT, AST, Gamma-GT level of > 3x ULN, respectively.
Presence of acute SIRS.
Presence of chronic infections.
Patients with higher risks of bleeding.
Subjects with uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg).
Subjects with random plasma glucose ≥180 mg/dL and HbA1c ≥ 7.0% at Screening.
Known or suspected hypersensitivity to the trial product or related products.
Participation in any other clinical studies within 30 days prior to screening.

Sites / Locations

Neurology Department, Dr. Kariadi General Hospital
Dr. Moewardi Hospital
Neurology Department Islam Jakarta Hospital (RSIJ) Cempaka Putih
Neurology Department Fatmawati Regional General Hospital
Neurology Department, Budhi Asih Hospital
Neurology Department, Pasar Rebo Hospital
Neurology Department Sidoarjo Regional General Hospital
Neurology Department, Haji Surabaya Hospital
Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

DLBS1033

Arm Description

Placebo 3 x 1 tablet, given everyday for 28 days of study period

DLBS1033 enteric-coated tablet 3 x 490 mg daily, given everyday for 28 days of study period

Outcomes

Primary Outcome Measures

National Institutes of Health Stroke Scale (NIHSS)

Change in functional outcomes as measured by NIHSS from its baseline value

Barthel Index (BI)

Change in functional outcomes as measured by BI from its baseline value

Secondary Outcome Measures

Thrombocyte Aggregation Test (TAT)

Change in haemostatic parameter as measured by TAT from its baseline value

Fibrinogen level

Change in haemostatic parameter as measured by fibrinogen level from its baseline value

D-dimer level

Change in haemostatic parameter as measured by d-dimer level from its baseline value

Liver function

Liver function measured includes: serum AST, ALT, gamma-GT, total bilirubin

Renal function

Renal function measured includes: serum creatinine

Routine hematology

Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count

Adverse events

Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study

Full Information

NCT ID

NCT02133521

First Posted

May 7, 2014

Last Updated

April 12, 2023

Sponsor

Dexa Medica Group

1. Study Identification

Unique Protocol Identification Number

NCT02133521

Brief Title

DLBS1033 for Acute Ischemic Stroke Patients

Acronym

ADDLIST

Official Title

Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 2014 (undefined)

Primary Completion Date

March 2023 (Actual)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dexa Medica Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke, Partial Anterior Circulation Infarct, Lacunar Anterior Circulation Infarct

Keywords

DLBS1033, Acute ischemic stroke, NIHSS, Barthel Index

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 3 x 1 tablet, given everyday for 28 days of study period

Arm Title

DLBS1033

Arm Type

Experimental

Arm Description

DLBS1033 enteric-coated tablet 3 x 490 mg daily, given everyday for 28 days of study period

Intervention Type

Drug

Intervention Name(s)

DLBS1033

Other Intervention Name(s)

Disolf

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Primary Outcome Measure Information:

Title

National Institutes of Health Stroke Scale (NIHSS)

Description

Change in functional outcomes as measured by NIHSS from its baseline value

Time Frame

3, 7, 14, and 28 days after study medication

Title

Barthel Index (BI)

Description

Change in functional outcomes as measured by BI from its baseline value

Time Frame

3, 7, 14, and 28 days after study medication

Secondary Outcome Measure Information:

Title

Thrombocyte Aggregation Test (TAT)

Description

Change in haemostatic parameter as measured by TAT from its baseline value

Time Frame

3, 7, 14, and 28 days after study medication

Title

Fibrinogen level

Description

Change in haemostatic parameter as measured by fibrinogen level from its baseline value

Time Frame

3, 7, 14, and 28 days after study medication

Title

D-dimer level

Description

Change in haemostatic parameter as measured by d-dimer level from its baseline value

Time Frame

3, 7, 14, and 28 days after study medication

Title

Liver function

Description

Liver function measured includes: serum AST, ALT, gamma-GT, total bilirubin

Time Frame

7 and 28 days after study medication

Title

Renal function

Description

Renal function measured includes: serum creatinine

Time Frame

7 and 28 days after study medication

Title

Routine hematology

Description

Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count

Time Frame

7 and 28 days after study medication

Title

Adverse events

Description

Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study

Time Frame

1 - 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent from the patients or patients' legally acceptable representatives (must be obtained before any trial related activities). Male or female subjects with age of >18 years at Screening. Patients clinically diagnosed having acute ischemic stroke attack and confirmed by CT scan. Patients with cerebral infarction subtypes of PACI or LACI as classified by Bamford criteria. Patients with moderate condition based on National Institutes of Health Stroke Scale (NIHSS) score of 5-15. Patients present at hospital and receiving first dose of study medication within 72 hours after the onset of the stroke symptoms. Able to take oral medication. Exclusion Criteria: For females of childbearing potential: pregnancy and lactation period. History of hemorrhagic stroke within the last 3 months. Patients with seizure at the onset of stroke or with regular medication for seizure/epilepsy. Current or regular use (within the last 1 month) of oral anticoagulants, antiplatelets other than study medication, and herbal medicines. Patients who have received tissue plasminogen activator (TPA) within 24 hours to Screening. History of serious head injury within the last 3 months. History of major surgery within the last 3 months. Recent serious cardiovascular conditions, such as myocardial infarction and heart atrial fibrillation as demonstrated by electrocardiography (ECG). History of congestive heart failure and aortic dissection. Presence of severe renal and hepatic dysfunction, defined as serum creatinine level > 3x upper limit of normal (ULN) or history of hemodialysis, and any of serum ALT, AST, Gamma-GT level of > 3x ULN, respectively. Presence of acute SIRS. Presence of chronic infections. Patients with higher risks of bleeding. Subjects with uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg). Subjects with random plasma glucose ≥180 mg/dL and HbA1c ≥ 7.0% at Screening. Known or suspected hypersensitivity to the trial product or related products. Participation in any other clinical studies within 30 days prior to screening.

Overall Study Officials: