DLBS1033 for Acute Ischemic Stroke Patients - Full Text View

Purpose

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	Intervention	Phase
Acute Ischemic Stroke Partial Anterior Circulation Infarct Lacunar Anterior Circulation Infarct	Drug: DLBS1033 Drug: Placebo	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients

Further study details as provided by Dexa Medica Group:

Primary Outcome Measures:

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


Estimated Enrollment:	160
Study Start Date:	October 2014
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	November 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Disolf

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


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 18-65 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02133521

Contacts


Contact: Fenny L Yudiarto, Sp.S(K), MD		fenny.yudiarto@yahoo.com
Contact: Hasan Machfoed, Prof., Sp.S(K), MD		mh.machfoed@gmail.com

Locations


Indonesia
Neurology Department, Dr. Kariadi General Hospital	Recruiting
Semarang, Central Java, Indonesia
Contact: Dodik Tugasworo, Sp.S(K), MD dodik_tugasworo@yahoo.com
Contact: Ratih V Octaviani, Sp.S., MSi., Med ratihapsoro@gmail.com
Sub-Investigator: Ratih V Octaviani, Sp.S.,MSi., MD
Sub-Investigator: Maria Belladonna R Sugianto, Sp.S., MD
Neurology Department, Kota Semarang District Public Hospital	Not yet recruiting
Semarang, Central Java, Indonesia
Contact: Riri G Sari, MD., SpS +6224 671 1500 riri.gusnita@yahoo.com
Principal Investigator: Riri G Sari, MD., SpS
Sub-Investigator: Mintarti Mintarti, MD., SpS
Sub-Investigator: Dyah N Widhiana, MD., SpS
Neurology Department, Haji Surabaya Hospital	Not yet recruiting
Surabaya, East Java, Indonesia
Contact: Diah H Soeryaningtias, dr., SpS +6231 592 4000 ext 5910 diahningtyas05@gmail.com
Principal Investigator: Diah H Soeryaningtias, MD. , SpS
Sub-Investigator: Wida Mardiana, MD. , SpS
Sub-Investigator: Neimy Novitasari, MD. , SpS
Sub-Investigator: Nuning Puspitaningrum, MD. , SpS
Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital	Recruiting
Surabaya, East Java, Indonesia
Contact: Wijoto, Sp.S(K), MD wijoto_neurologi@yahoo.co.id
Contact: Achmad Firdaus Sani, Sp.S., FINS achmad_sani@yahoo.co.id
Sub-Investigator: Paulus Sugianto, Sp.S(K), MD
Sub-Investigator: Achmad F Sani, Sp.S., FINS, MD
Sub-Investigator: Fadil, Sp.S., MD
Sub-Investigator: Devi A Sudibyo, Sp.S., MD
Sub-Investigator: Yudhi Adrianto, Sp.S., MD
Sub-Investigator: Djohan Ardiansyah, Sp.S, MD
Cerebrovascular, Neurosonology, and Intervention, Neurology Division, Neurology Department, Dr. Cipto Mangunkusumo Hospital	Not yet recruiting
Jakarta, Indonesia
Contact: Diatri N Lastri, Sp.S(K), MD nari_ade@yahoo.com
Contact: Mohammad Kurniawan, Sp.S., FICA mkurniawan.md@gmail.com
Sub-Investigator: Mohammad Kurniawan, Sp.S, MD
Sub-Investigator: Salim Harris, Sp.S(K), MD

Sponsors and Collaborators

Dexa Medica Group

Investigators


Study Director:	Hasan Machfoed, Prof, Sp.S(K), MD	Neurology Department Dr. Soetomo Hospital
Study Chair:	Fenny L Yudiarto, Sp.S(K), MD	Indonesia's Neurologists Organization (Perdossi)
Principal Investigator:	Wijoto, Sp.S(K), MD	Neurology Department Dr. Soetomo Hospital
Principal Investigator:	Diatri N Lastri, Sp.S(K), MD	Neurology Department Dr. Cipto Mangunkusumo Hospital
Principal Investigator:	Dodik Tugasworo, Sp.S(K), MD	Neurology Department Dr. Kariadi General Hospital

More Information


Responsible Party:	Dexa Medica Group
ClinicalTrials.gov Identifier:	NCT02133521 History of Changes
Other Study ID Numbers:	DLBS1033-0111
Study First Received:	May 7, 2014
Last Updated:	February 8, 2017

Keywords provided by Dexa Medica Group:


DLBS1033 Acute ischemic stroke NIHSS Barthel Index

Additional relevant MeSH terms:


Stroke Ischemia Cerebral Infarction Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases	Pathologic Processes Brain Infarction Brain Ischemia Necrosis Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 17, 2017

DLBS1033 for Acute Ischemic Stroke Patients (ADDLIST)