DLBS1033 for Acute Ischemic Stroke Patients (ADDLIST)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Dexa Medica Group
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT02133521
First received: May 7, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  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
Ischemic Stroke
Partial Anterior Circulation Infarction
Lacunar Infarction by Bamford Criteria
Drug: DLBS1033
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Improvement in NIHSS [ Time Frame: 3, 7, 14, and 28 days ] [ Designated as safety issue: No ]
    Change in functional outcomes as measured by National Institutes of Health Stroke Scale (NIHSS) from its baseline value

  • Improvement in BI [ Time Frame: 3, 7, 14, and 28 days ] [ Designated as safety issue: No ]
    Change in functional outcomes as measured by Barthel Index (BI) from its baseline value


Secondary Outcome Measures:
  • Improvement in TAT [ Time Frame: 3, 7, 14, and 28 days ] [ Designated as safety issue: No ]
    Change in haemostatic parameter as measured by Thrombocyte Aggregation Test (TAT) from its baseline value

  • Improvement in fibrinogen level [ Time Frame: 3, 7, 14, and 28 days ] [ Designated as safety issue: No ]
    Change in haemostatic parameter as measured by fibrinogen level from its baseline value

  • Improvement in d-dimer level [ Time Frame: 3, 7, 14, and 28 days ] [ Designated as safety issue: No ]
    Change in haemostatic parameter as measured by d-dimer level from its baseline value

  • Liver function [ Time Frame: 7 and 28 days ] [ Designated as safety issue: Yes ]
    Liver function measured includes: serum AST, ALT, G-GT, total bilirubin

  • Renal function [ Time Frame: 7 and 28 days ] [ Designated as safety issue: Yes ]
    Renal function measured includes: serum creatinine

  • Routine hematology [ Time Frame: 7 and 28 days ] [ Designated as safety issue: Yes ]
    Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count

  • Adverse events [ Time Frame: 1 - 28 days ] [ Designated as safety issue: Yes ]
    Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study


Estimated Enrollment: 160
Study Start Date: May 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (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
Genders Eligible for Study:   Both
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.
  • Patients or patients' legally acceptable representatives are able and willing to record adverse events in a diary.
  • Patients or patients' legally acceptable representatives have the ability to comply with the trial protocol.

Exclusion Criteria:

  • For females of childbearing potential: pregnancy and lactation period. Patients must accept pregnancy tests during the trial if menstrual cycle is missed. Fertile patients must use effective contraception.
  • 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 Not yet 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, MD         
Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital Not yet recruiting
Surabaya, East Java, Indonesia
Contact: Wijoto, Sp.S(K), MD       wijoto_neurologi@yahoo.co.id   
Contact: Achmad Firdaus Sani, Sp.S(K), FINS       achmad_sani@yahoo.co.id   
Sub-Investigator: Paulus Sugianto, Sp.S(K), MD         
Sub-Investigator: Achmad F Sani, 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         
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

No publications provided

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: May 7, 2014
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:
DLBS1033
acute ischemic stroke
NIHSS
Barthel Index

Additional relevant MeSH terms:
Infarction
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 22, 2014