ADDLIST: DLBS1033 for Acute Ischemic Stroke Patients

Sponsor

Dexa Medica Group (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02133521

Collaborator

(none)

160

Enrollment

Locations

Arms

107

Duration (Months)

17.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke Partial Anterior Circulation Infarct Lacunar Anterior Circulation Infarct	Drug: DLBS1033 Drug: Placebo	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo 3 x 1 tablet, given everyday for 28 days of study period	Drug: 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
Experimental: DLBS1033 DLBS1033 enteric-coated tablet 3 x 490 mg daily, given everyday for 28 days of study period	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 Other Names: Disolf

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Drug: 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

Experimental: DLBS1033

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

Drug: DLBS1033

Other Names:

Disolf

Outcome Measures

Primary Outcome Measures

National Institutes of Health Stroke Scale (NIHSS) [3, 7, 14, and 28 days after study medication]
Change in functional outcomes as measured by NIHSS from its baseline value
Barthel Index (BI) [3, 7, 14, and 28 days after study medication]
Change in functional outcomes as measured by BI from its baseline value

Secondary Outcome Measures

Thrombocyte Aggregation Test (TAT) [3, 7, 14, and 28 days after study medication]
Change in haemostatic parameter as measured by TAT from its baseline value
Fibrinogen level [3, 7, 14, and 28 days after study medication]
Change in haemostatic parameter as measured by fibrinogen level from its baseline value
D-dimer level [3, 7, 14, and 28 days after study medication]
Change in haemostatic parameter as measured by d-dimer level from its baseline value
Liver function [7 and 28 days after study medication]
Liver function measured includes: serum AST, ALT, gamma-GT, total bilirubin
Renal function [7 and 28 days after study medication]
Renal function measured includes: serum creatinine
Routine hematology [7 and 28 days after study medication]
Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
Adverse events [1 - 28 days]
Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Neurology Department, Dr. Kariadi General Hospital	Semarang	Central Java	Indonesia
2	Dr. Moewardi Hospital	Surakarta	Central Java	Indonesia
3	Neurology Department Islam Jakarta Hospital (RSIJ) Cempaka Putih	Jakarta Pusat	DKI Jakarta	Indonesia
4	Neurology Department Fatmawati Regional General Hospital	Jakarta	DKI Jakarta	Indonesia
5	Neurology Department, Budhi Asih Hospital	Jakarta	DKI Jakarta	Indonesia
6	Neurology Department, Pasar Rebo Hospital	Jakarta	DKI Jakarta	Indonesia
7	Neurology Department Sidoarjo Regional General Hospital	Sidoarjo	East Java	Indonesia
8	Neurology Department, Haji Surabaya Hospital	Surabaya	East Java	Indonesia
9	Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital	Surabaya	East Java	Indonesia

Sponsors and Collaborators

Dexa Medica Group

Investigators

Study Chair: Paulus Sugianto, Sp.S(K), Dr, MD, Indonesia's Neurologists Organization (Perdossi)
Principal Investigator: 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
Principal Investigator: 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