DLBS1033 for Acute Ischemic Stroke Patients

NCT02133521 | Terminated Phase 2 DMC

• 1 other identifier: DLBS1033-0111
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Keywords

DLBS1033; Acute ischemic stroke; NIHSS; Barthel Index

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Thrombocyte Aggregation Test (TAT)

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

• Fibrinogen level

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

• D-dimer level

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

• Liver function

  7 and 28 days after study medication

• Renal function

  7 and 28 days after study medication

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

DLBS1033

EXPERIMENTAL

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

Drug: DLBS1033

Interventions

DLBS1033 DRUG

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

Also known as: Disolf

DLBS1033

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (10)

Neurology Department, Dr. Kariadi General Hospital

Semarang, Central Java, Indonesia

Location

Universitas Sebelas Maret (UNS) Hospital

Sukoharjo, Central Java, Indonesia

Location

Dr. Moewardi Hospital

Surakarta, Central Java, Indonesia

Location

Neurology Department Fatmawati Regional General Hospital

Jakarta, DKI Jakarta, Indonesia

Location

Neurology Department, Budhi Asih Hospital

Jakarta, DKI Jakarta, Indonesia

Location

Neurology Department, Pasar Rebo Hospital

Jakarta, DKI Jakarta, Indonesia

Location

Neurology Department Islam Jakarta Hospital (RSIJ) Cempaka Putih

Jakarta Pusat, DKI Jakarta, Indonesia

Location

Neurology Department Sidoarjo Regional General Hospital

Sidoarjo, East Java, Indonesia

Location

Neurology Department, Haji Surabaya Hospital

Surabaya, East Java, Indonesia

Location

Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital

Surabaya, East Java, Indonesia

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

DLBS 1033

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paulus Sugianto, Sp.S(K), Dr, MD

  Indonesia's Neurologists Organization (Perdossi)

  STUDY CHAIR

• Muh. Hamdan, Sp.S(K), MD

  Neurology Department Dr. Soetomo Hospital

  PRINCIPAL INVESTIGATOR

• Dodik Tugasworo, Sp.S(K), MD

  Neurology Department Dr. Kariadi General Hospital

  STUDY DIRECTOR

• Dian Cahyani, Sp.S, MD

  Neurology Department Budhi Asih Hospital

  PRINCIPAL INVESTIGATOR

• Diah H Soeryaningtias, Sp.S, MD

  Neurology Department Haji Surabaya Hospital

  PRINCIPAL INVESTIGATOR

• Gotot S PW, Sp.S, MD

  Neurology Department Pasar Rebo Hospital

  PRINCIPAL INVESTIGATOR

• Sugeng Wijayanto, Sp.S, MD

  Neurology Department Sidoarjo Regional General Hospital

  PRINCIPAL INVESTIGATOR

• Ika Y Margaretha, Sp.S, MD

  Neurology Department Fatmawati Regional General Hospital

  PRINCIPAL INVESTIGATOR

• Wiwin Sundawiyani, Sp.S, MD

  Islam Jakarta Hospital (RSIJ) Cempaka Putih

  PRINCIPAL INVESTIGATOR

• Rivan Danuaji, Sp.N(K), MD

  Neurology Department Dr. Moewardi Hospital

  PRINCIPAL INVESTIGATOR

• Hanindia R. Prabaningtyas, Sp.S(K), MD

  Neurology Department Universitas Sebelas Maret (UNS) Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 8, 2014
• Study Start: November 11, 2014
• Primary Completion: February 21, 2023
• Study Completion: April 21, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

ID (10)