DLBS1033 for Acute Ischemic Stroke Patients

Acute Ischemic Stroke Clinical Trial

— ADDLIST  

Official title:

Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02133521
• Other study ID #: DLBS1033-0111
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: November 11, 2014
• Est. completion date: April 21, 2023

Study information

• Verified date: December 2023
• Source: Dexa Medica Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: April 21, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Infarction
• Ischemia
• Ischemic Stroke
• Lacunar Anterior Circulation Infarct
• Partial Anterior Circulation Infarct
• Stroke

Intervention

Drug:
• DLBS1033
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
• Placebo
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

Locations

Country	Name	City	State
Indonesia	Neurology Department Fatmawati Regional General Hospital	Jakarta	DKI Jakarta
Indonesia	Neurology Department, Budhi Asih Hospital	Jakarta	DKI Jakarta
Indonesia	Neurology Department, Pasar Rebo Hospital	Jakarta	DKI Jakarta
Indonesia	Neurology Department Islam Jakarta Hospital (RSIJ) Cempaka Putih	Jakarta Pusat	DKI Jakarta
Indonesia	Neurology Department, Dr. Kariadi General Hospital	Semarang	Central Java
Indonesia	Neurology Department Sidoarjo Regional General Hospital	Sidoarjo	East Java
Indonesia	Universitas Sebelas Maret (UNS) Hospital	Sukoharjo	Central Java
Indonesia	Neurology Department, Haji Surabaya Hospital	Surabaya	East Java
Indonesia	Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital	Surabaya	East Java
Indonesia	Dr. Moewardi Hospital	Surakarta	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health Stroke Scale (NIHSS)	Change in functional outcomes as measured by NIHSS from its baseline value	3, 7, 14, and 28 days after study medication
Primary	Barthel Index (BI)	Change in functional outcomes as measured by BI from its baseline value	3, 7, 14, and 28 days after study medication
Secondary	Thrombocyte Aggregation Test (TAT)	Change in haemostatic parameter as measured by TAT from its baseline value	3, 7, 14, and 28 days after study medication
Secondary	Fibrinogen level	Change in haemostatic parameter as measured by fibrinogen level from its baseline value	3, 7, 14, and 28 days after study medication
Secondary	D-dimer level	Change in haemostatic parameter as measured by d-dimer level from its baseline value	3, 7, 14, and 28 days after study medication
Secondary	Liver function	Liver function measured includes: serum AST, ALT, gamma-GT, total bilirubin	7 and 28 days after study medication
Secondary	Renal function	Renal function measured includes: serum creatinine	7 and 28 days after study medication
Secondary	Routine hematology	Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count	7 and 28 days after study medication
Secondary	Adverse events	Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study	1 - 28 days