Clinical trial NCT02133521: DLBS1033 for Acute Ischemic Stroke Patients
Official title: Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Acute Ischemic Stroke
Partial Anterior Circulation Infarct
Lacunar Anterior Circulation Infarct
Keywords: DLBS1033
Acute ischemic stroke
NIHSS
Barthel Index
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2014-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 3, 7, 14, and 28 days after study medication
measure: Barthel Index (BI)
timeFrame: 3, 7, 14, and 28 days after study medication
Secondary outcomes:
measure: Thrombocyte Aggregation Test (TAT)
timeFrame: 3, 7, 14, and 28 days after study medication
measure: Fibrinogen level
timeFrame: 3, 7, 14, and 28 days after study medication
measure: D-dimer level
timeFrame: 3, 7, 14, and 28 days after study medication
measure: Liver function
timeFrame: 7 and 28 days after study medication
measure: Renal function
timeFrame: 7 and 28 days after study medication
measure: Routine hematology
timeFrame: 7 and 28 days after study medication
measure: Adverse events
timeFrame: 1 - 28 days
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Neurology Department, Dr. Kariadi General Hospital
state: Central Java
city: Sukoharjo
country: Indonesia
facility: Universitas Sebelas Maret (UNS) Hospital
state: Central Java
city: Surakarta
country: Indonesia
facility: Dr. Moewardi Hospital
state: Central Java
city: Jakarta Pusat
country: Indonesia
facility: Neurology Department Islam Jakarta Hospital (RSIJ) Cempaka Putih
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Neurology Department Fatmawati Regional General Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Neurology Department, Budhi Asih Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Neurology Department, Pasar Rebo Hospital
state: DKI Jakarta
city: Sidoarjo
country: Indonesia
facility: Neurology Department Sidoarjo Regional General Hospital
state: East Java
city: Surabaya
country: Indonesia
facility: Neurology Department, Haji Surabaya Hospital
state: East Java
city: Surabaya
country: Indonesia
facility: Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital
state: East Java
Study officials:
affiliation: Indonesia's Neurologists Organization (Perdossi)
name: Paulus Sugianto, Sp.S(K), Dr, MD
role: STUDY_CHAIR
affiliation: Neurology Department Dr. Soetomo Hospital
name: Muh. Hamdan, Sp.S(K), MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Department Dr. Kariadi General Hospital
name: Dodik Tugasworo, Sp.S(K), MD
role: STUDY_DIRECTOR
affiliation: Neurology Department Budhi Asih Hospital
name: Dian Cahyani, Sp.S, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Department Haji Surabaya Hospital
name: Diah H Soeryaningtias, Sp.S, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Department Pasar Rebo Hospital
name: Gotot S PW, Sp.S, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Department Sidoarjo Regional General Hospital
name: Sugeng Wijayanto, Sp.S, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Department Fatmawati Regional General Hospital
name: Ika Y Margaretha, Sp.S, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Islam Jakarta Hospital (RSIJ) Cempaka Putih
name: Wiwin Sundawiyani, Sp.S, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Department Dr. Moewardi Hospital
name: Rivan Danuaji, Sp.N(K), MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Department Universitas Sebelas Maret (UNS) Hospital
name: Hanindia R. Prabaningtyas, Sp.S(K), MD
role: PRINCIPAL_INVESTIGATOR
References: