Acute Ischemic StrokePhase 3NCT02362984
DLBS1033 for the Treatment of Acute Ischemic Stroke
A Phase 3 study testing DLBS1033 in people with Acute Ischemic Stroke, run by Dexa Medica Group at 1 site in Indonesia.
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 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- DLBS1033
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2014to Apr 2017
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with age of 18-75 years .
- Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan.
- Modified National Institutes of Health Stroke Scale (mNIHSS) score >= 5.
- 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 or current hemorrhagic stroke (within the last 3 months).
- Transient ischemic stroke (TIA).
- Patients with seizure at the onset of stroke.
- History of serious head injury within the last 3 months.
- History of major surgery within the last 3 months.
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- Serious cardiovascular conditions, such as myocardial infarction, CHF grade III and IV (NYHA classification), aorta dissection, and atrial fibrillation within the last 6 months.
- Presence of severe renal or hepatic dysfunction
- Presence of acute or chronic infections.
- Thrombocytopenia (thrombocytes level < 150.000/ul).
- Patients with higher risks of bleeding.
- Uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg).
- Random plasma glucose >= 200 mg/dL.
- Current or regular use of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.
- Hypersensitive to the investigational product(s).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: A Randomized Controlled Study
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 the detailed description
Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 at a dose of 490 mg three times daily (as DLBS1033 group). Standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin B complex, and citicholine 250 mg/2 mL twice daily.
After hospital admission and diagnosis, patient will be handled according to the standard management for acute ischemic stroke applicable in the hospital. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Placebo, DLBS1033
- Keywords
- DLBS1033, acute ischemic stroke, MRS, mNIHSS
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo of DLBS1033
Placebo of DLBS1033 will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily
DLBS1033Drug
Also called Disolf
DLBS1033 enteric-coated tablets will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Placebo will be administered orally, 3 x 1 tablet daily, for 8 days of study period Receives: Drug: Placebo |
| DLBS1033 Group | Experimental | DLBS1033 will be administered orally, 3 x 1 tablet daily, for 8 days of study period Receives: Drug: DLBS1033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in mNIHSS score
Change in functional outcomes as measured by The Modified National Institute of Health Stroke Scale (mNIHSS) from its baseline value
Measured: 7 days after treatment initiation
Secondary outcomes (8)
Improvement in MRS
Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its baseline value
Measured: 7 days after treatment initiation
Improvement in fibrinogen level
Change in haemostatic parameter as measured by fibrinogen level from its baseline value
Measured: 7 days after treatment initiation
Improvement in d-dimer level
Change in haemostatic parameter as measured by d-dimer level from its baseline value
Measured: 7 days after treatment initiation
Liver function
Liver function measured will be: serum AST, ALT, G-GT, total bilirubin
Measured: 7 days after treatment initiation
Renal function
Renal function measured will be serum creatinine
Measured: 7 days after treatment initiation
Routine hematology
Routine hematology measured will be: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
Measured: 7 days after treatment initiation
Hemostasis parameters
Hemostasis parameters measured will be: PT and aPTT
Measured: 7 days after treatment initiation
Adverse events
Adverse events, including bleeding events, will be observed and carefully evaluated during the expected average of 7 days of study treatment.
Measured: 7 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startOct 2014
- Primary completionFeb 2017
- Study completionApr 2017
Why it stopped: Major technical hindrance in recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tut W Handayani, Sp.S, MD, Principal investigator, RSUD R. Syamsudin, SH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362984
- Sponsor's protocol ID
- DLBS1033-0614
- Status last verified
- May 2017
- First submitted
- 3 Feb 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02362984
- Acronym / sponsor ID
- DLBS1033-0614
- Conditions
- Acute Ischemic Stroke
- Keywords
- DLBS1033, acute ischemic stroke, MRS, mNIHSS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Major technical hindrance in recruitment.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 at a dose of 490 mg three times daily (as DLBS1033 group). Standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin B complex, and citicholine 250 mg/2 mL twice daily.
After hospital admission and diagnosis, patient will be handled according to the standard management for acute ischemic stroke applicable in the hospital. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: PlaceboPlacebo will be administered orally, 3 x 1 tablet daily, for 8 days of study period |
| DLBS1033 Group | Experimental | Drug: DLBS1033DLBS1033 will be administered orally, 3 x 1 tablet daily, for 8 days of study period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects with age of 18-75 years .
- Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan.
- Modified National Institutes of Health Stroke Scale (mNIHSS) score >= 5.
- 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.
Key exclusion criteria (15 listed)
- For females of childbearing potential: pregnancy and lactation period.
- History of or current hemorrhagic stroke (within the last 3 months).
- Transient ischemic stroke (TIA).
- Patients with seizure at the onset of stroke.
- History of serious head injury within the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Placebo of DLBS1033Placebo of DLBS1033 will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily | Drug | Control Group |
| DLBS1033Also: DisolfDLBS1033 enteric-coated tablets will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily | Drug | DLBS1033 Group |
Primary outcome
Improvement in mNIHSS score
Time frame: 7 days after treatment initiation
Change in functional outcomes as measured by The Modified National Institute of Health Stroke Scale (mNIHSS) from its baseline value
8 secondary outcomes
Improvement in MRS
Time frame: 7 days after treatment initiation
Improvement in fibrinogen level
Time frame: 7 days after treatment initiation
Improvement in d-dimer level
Time frame: 7 days after treatment initiation
Liver function
Time frame: 7 days after treatment initiation
Renal function
Time frame: 7 days after treatment initiation
Routine hematology
Time frame: 7 days after treatment initiation
Hemostasis parameters
Time frame: 7 days after treatment initiation
Adverse events
Time frame: 7 days after treatment initiation
Results and safety
The study was stopped early (reason given: Major technical hindrance in recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tut W Handayani, Sp.S, MD principal investigator
RSUD R. Syamsudin, SH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DLBS1033 in people with Acute Ischemic Stroke, run by Dexa Medica Group at 1 site 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 5 inclusion and 15 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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: Major technical hindrance in recruitment.). 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?
Improvement in mNIHSS score (time frame: 7 days after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2017.