AzTrials
AzTrials

Acute Ischemic StrokePhase 2/3ADDLISTNCT02133521

DLBS1033 for Acute Ischemic Stroke Patients

A Phase 2/3 study testing DLBS1033 in people with Acute Ischemic Stroke and Partial Anterior Circulation Infarct, run by Dexa Medica Group at 10 sites in Indonesia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DLBS1033
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
10 sitesIndonesia
Study dates
11 Nov 2014to 21 Apr 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Indonesia10 sites

  • Neurology Department Fatmawati Regional General Hospital

    Jakarta, DKI Jakarta

  • Neurology Department, Budhi Asih Hospital

    Jakarta, DKI Jakarta

  • Neurology Department, Pasar Rebo Hospital

    Jakarta, DKI Jakarta

  • Neurology Department Islam Jakarta Hospital (RSIJ) Cempaka Putih

    Jakarta Pusat, DKI Jakarta

  • Neurology Department, Dr. Kariadi General Hospital

    Semarang, Central Java

  • Neurology Department Sidoarjo Regional General Hospital

    Sidoarjo, East Java

  • Universitas Sebelas Maret (UNS) Hospital

    Sukoharjo, Central Java

  • Neurology Department, Haji Surabaya Hospital

    Surabaya, East Java

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

    Surabaya, East Java

  • Dr. Moewardi Hospital

    Surakarta, Central Java

Other trials in Indonesia

About this study

Official title: Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients

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.

Read the 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.

Being tested
DLBS1033, Placebo
Keywords
DLBS1033, Acute ischemic stroke, NIHSS, Barthel Index
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DLBS1033Drug

    Also called Disolf

    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

  • PlaceboDrug

    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

Study groups in NCT02133521
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo 3 x 1 tablet, given everyday for 28 days of study period
Receives: Drug: Placebo
DLBS1033ExperimentalDLBS1033 enteric-coated tablet 3 x 490 mg daily, given everyday for 28 days of study period
Receives: Drug: DLBS1033

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. National Institutes of Health Stroke Scale (NIHSS)

    Change in functional outcomes as measured by NIHSS from its baseline value

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

  2. Barthel Index (BI)

    Change in functional outcomes as measured by BI from its baseline value

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

Secondary outcomes (7)

  1. Thrombocyte Aggregation Test (TAT)

    Change in haemostatic parameter as measured by TAT from its baseline value

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

  2. Fibrinogen level

    Change in haemostatic parameter as measured by fibrinogen level from its baseline value

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

  3. D-dimer level

    Change in haemostatic parameter as measured by d-dimer level from its baseline value

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

  4. Liver function

    Liver function measured includes: serum AST, ALT, gamma-GT, total bilirubin

    Measured: 7 and 28 days after study medication

  5. Renal function

    Renal function measured includes: serum creatinine

    Measured: 7 and 28 days after study medication

  6. Routine hematology

    Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count

    Measured: 7 and 28 days after study medication

  7. Adverse events

    Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study

    Measured: 1 - 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2014 (estimated)
  2. Study start11 Nov 2014
  3. Primary completion21 Feb 2023
  4. Study completion21 Apr 2023

Why it stopped: Very low recruitment rate. The Study Sites classified as tertiary referral hospital. Therefore, patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02133521
Sponsor's protocol ID
DLBS1033-0111
Acronym
ADDLIST
Status last verified
Dec 2023
First submitted
7 May 2014
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DLBS1033 in people with Acute Ischemic Stroke and Partial Anterior Circulation Infarct, run by Dexa Medica Group at 10 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Very low recruitment rate. The Study Sites classified as tertiary referral hospital. Therefore, patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

National Institutes of Health Stroke Scale (NIHSS) (time frame: 3, 7, 14, and 28 days after study medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02133521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in