Acute Ischemic StrokePhase 3NCT01790997
Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke
A Phase 3 study testing DLBS1033, Aspirin and Clopidogrel in people with Acute Ischemic Stroke, run by Dexa Medica Group at 1 site in Indonesia.
Trial summary
This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- DLBS1033, Aspirin and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2012to Dec 2013
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 20-80 years old
- Having non-bleeding stroke in CT scan examination
- Having stroke attack onset ≤ 96 hours
- Living in 100 km from RSUP Dr Sardjito Jogjakarta
Who cannot join
- Having recurrence stroke
- Having Transient Ischemic Attack (TIA)
- Have been regularly taking anti-aggregation agent
- Having intracerebral and subarachnoid bleeding stroke
- Subjects and their family do not know when the stroke symptoms appeared
- History of haemostasis disorder
- History of or will have surgery within 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital
Yogyakarta, Special Region of Yogyakarta, 55281
About this study
Official title: The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel
This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.
Read the detailed description
There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens :
- Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal
- Treatment II : 1 tablet of aspirin 80 mg once daily, after meal
- Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal
Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (Month 3rd). General condition of the subjects will be followed-up every month over three months of study medication.
Physiotherapy will be provided to the subjects by the assigned Physiotherapist.
- Conditions
- Acute Ischemic Stroke
- Being tested
- DLBS1033, Aspirin, Clopidogrel
- Keywords
- DLBS1033, Lumbrokinase, Acute ischemic stroke, Bleeding profile, Clinical outcome, Aspirin, Clopidogrel
- 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
1 tablet of DLBS1033 490 mg thrice daily, after meal
AspirinDrug
1 tablet of aspirin 80 mg once daily, after meal
ClopidogrelDrug
1 tablet of clopidogrel 75 mg once daily, after meal
| Study group | Role | What they receive |
|---|---|---|
| Treatment I | Experimental | 1 tablet of DLBS1033 490 mg thrice daily, after meal Receives: Drug: DLBS1033 |
| Treatment II | Active comparator | 1 tablet of aspirin 80 mg once daily, after meal Receives: Drug: Aspirin |
| Treatment III | Active comparator | 1 tablet of clopidogrel 75 mg once daily, after meal Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in INR value
Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)
Measured: 3 Months
Secondary outcomes (4)
Change in PT
Change in PT (prothrombin time) from baseline to end of study (Month 3rd)
Measured: 3 Months
Change in aPTT
Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd)
Measured: 3 Months
Change in Gadjah Mada Stroke Scale
Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd)
Measured: 3 Months
Change in Barthel Index
Change in Barthel Index from baseline to end of study (Month 3rd)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startMay 2012
- Primary completionNov 2013
- Study completionDec 2013
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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ismail Setyopranoto, dr., SpS(K), Principal investigator, Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790997
- Sponsor's protocol ID
- DLBS1033-UST-001.11
- Status last verified
- Jan 2014
- First submitted
- 12 Feb 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel
- ClinicalTrials.gov ID
- NCT01790997
- Acronym / sponsor ID
- DLBS1033-UST-001.11
- Conditions
- Acute Ischemic Stroke
- Keywords
- DLBS1033, Lumbrokinase, Acute ischemic stroke, Bleeding profile, Clinical outcome, Aspirin, Clopidogrel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Feb 2013 (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 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.
Detailed description
There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens :
- Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal
- Treatment II : 1 tablet of aspirin 80 mg once daily, after meal
- Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal
Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (Month 3rd). General condition of the subjects will be followed-up every month over three months of study medication.
Physiotherapy will be provided to the subjects by the assigned Physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment I | Experimental | Drug: DLBS10331 tablet of DLBS1033 490 mg thrice daily, after meal |
| Treatment II | Active comparator | Drug: Aspirin1 tablet of aspirin 80 mg once daily, after meal |
| Treatment III | Active comparator | Drug: Clopidogrel1 tablet of clopidogrel 75 mg once daily, after meal |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects aged 20-80 years old
- Having non-bleeding stroke in CT scan examination
- Having stroke attack onset ≤ 96 hours
- Living in 100 km from RSUP Dr Sardjito Jogjakarta
Key exclusion criteria (7 listed)
- Having recurrence stroke
- Having Transient Ischemic Attack (TIA)
- Have been regularly taking anti-aggregation agent
- Having intracerebral and subarachnoid bleeding stroke
- Subjects and their family do not know when the stroke symptoms appeared
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 |
|---|---|---|
| DLBS10331 tablet of DLBS1033 490 mg thrice daily, after meal | Drug | Treatment I |
| Aspirin1 tablet of aspirin 80 mg once daily, after meal | Drug | Treatment II |
| Clopidogrel1 tablet of clopidogrel 75 mg once daily, after meal | Drug | Treatment III |
Primary outcome
Change in INR value
Time frame: 3 Months
Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)
4 secondary outcomes
Change in PT
Time frame: 3 Months
Change in aPTT
Time frame: 3 Months
Change in Gadjah Mada Stroke Scale
Time frame: 3 Months
Change in Barthel Index
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
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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.
Ismail Setyopranoto, dr., SpS(K) principal investigator
Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia
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, Aspirin and Clopidogrel 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Jun 2014. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in INR value (time frame: 3 Months). 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 Jun 2014.