Acute StrokePhase 4NCT03847883
Low-dose Versus Standard Dose Alteplase in Acute Ischemic Stroke , 4 Monthes Prospective Study
A Phase 4 study testing Intravenous Solution Ateplase in people with Acute Stroke, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Cohort A Randomized Control trial of Ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients Cohort B single arm 0.9 mg/kg Ateplase in 330 patients Combined Cohort A and B evaluate different of death, intra-cerebral hemorrhage, numberof patient with mRS 0-1 at discharge and 3 months follow up, and other important stroke… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Intravenous Solution Ateplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2011to 14 Feb 2019
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Acute ischemic stroke
- Age 18 to 80 years
- Onset of stroke symptoms with in 4.5 hours before initiation of study-drug administration
- Stroke symptoms present for at least 30 minutes with no significant improvement before treatment
Who cannot join
- patients with Intracranial hemorrhage
- the symptoms of Time onset was unknown
- Symptoms rapidly improving or only minor before start of infusion
- Seizure at the onset of stroke
- Stroke or serious head trauma within the previous 3 months
- Administration of heparin within the 48 hours preceding the onset of stroke, with an activate
Show all 14Show fewer
- partial-thromboplastin time at presentation exceeding the upper limit of the normal range
- Platelet count of less than 100,000 per cubic millimeter
- Systole pressure greater than 185 mm Hg or diastole pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
- Blood glucose less than 50 mg per deciliter or greater than 400 mg per deciliter
- Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
- Oral anticoagulant treatment
- Major surgery or severe trauma within the previous 3 months
- Other major disorders associated with an increased risk of bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-dose Versus Standard-dose Ateplase in Acute Ischemic Stroke ; A 4 Months Prospective Randomized Control Pilot Follow by Single Arm Standard Dose Ateplase Study.
Cohort A Randomized Control trial of Ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients Cohort B single arm 0.9 mg/kg Ateplase in 330 patients Combined Cohort A and B evaluate different of death, intra-cerebral hemorrhage, numberof patient with mRS 0-1 at discharge and 3 months follow up, and other important stroke outcomes
Read the detailed description
We conducted the prospective study to compare the low-dose and standard-dose rtPa and identify the important factors predicted stroke outcomes in acute stroke patient received intravenous rtPa. In Cohort A, During 2011-2012, 78 patients were randomly assigned to received intravenous rtPa 0.6 mg/kg , 0.75 mg/Kg, or 0.9 mg/Kg (1:1:1). After interim analysis during 2012-2017, in Cohort B, 330 patients were assigned to receive standard-dose rtPa 0.9 mg/kg. The good outcomes were defined as improvement of modified Rankin scale (mRS) by final score 0-1 or improvement > 4 points at discharge or 3 months follow up, absent of intracranial hemorrhage within 36 hours treatment, 90-day post-stroke survival , and short hospital length of stay.
- Conditions
- Acute Stroke
- Being tested
- Intravenous Solution Ateplase
- Keywords
- Ateplase, Intravenous recombinant tissue plasminogen activator, Acute is hemic stroke, Low-dose Ateplase, rtPa, Modified Rankin 's Scale
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Solution AteplaseDrug
Infusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke
| Study group | Role | What they receive |
|---|---|---|
| 0.6 mg/kg Ateplase | Active comparator | Low dose 0.6 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke (n = 26 in cohort A) Receives: Drug: Intravenous Solution Ateplase |
| 0.75 mg/kg Ateplase | Active comparator | Low dose 0.75 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A) Receives: Drug: Intravenous Solution Ateplase |
| 0.9 mg/kg Ateplase | Active comparator | Low dose 0.9 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A and n= 330 in Cohort B) Receives: Drug: Intravenous Solution Ateplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death in 36 hours
Number of patient die in 36 hours
Measured: 0-36 hours
Death in 3 months
Number of patient die in 3 months
Measured: 0-3 months
Death in 4 months
Number of patient die in 4 months
Measured: 0-4 months
Total number of patients with mRS 0-1 at discharged
Number of patients with mRS 0-1 at discharge 1day to 3 months interval
Measured: 1day to <3 months
Total number of patients with mRS 0-1 at 3 months
Number of patients with mRS 0-1 at 3 months
Measured: At 3 months
Number of patients with All intra-cerebral hemorrhage (ICH) at 36 hours
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Measured: 0- 36 hours
Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Measured: 0-3 months
Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Measured: 0-4 months
Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 36 hours
Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Measured: 0-36 hours
Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 4 months
Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Measured: 0-4 months
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 36 hours
Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Measured: 0-36 hours
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 3 months
Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Measured: 0-3 months
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 4 months
Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Measured: 0-4 months
Secondary outcomes (5)
Good stroke outcomes
Total number of patients with "good outcomes" were defined as number of patients with this any one item criteria
- improvement of modified Rankin scale (mRS) by final score 0-1
- mRS improvement > 4 points at discharge or 3 months follow up, And must full fill all of this criteria
- absent of intracranial hemorrhage within 36 hours treatment and 2) survive at 90-day post-stroke ,and 3) short hospital length of stay less than 7 days
Measured: 0-4 months
Improved mRS at discharge
Number of patients with improve mRS after treatment at least 1 Score
Measured: (At discharge) 1 day to 3 months
Improved mRS 3 months
Number of patients with improve mRS after treatment at least 1 Score
Measured: At 3 months
Number of patienta with Length of hospital stay (LOS) less than 7 days Days
Number of patients with LOS < 7 days ( patients must survive )
Measured: 1- 7 days
All complications
Number of patients with stroke complications after treatment
Measured: 0-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Jan 2011
- Primary completion31 Dec 2018
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort A double blind Randomized controlled trial 0.6 or 0.7 or 0.9 mg/Kg Ateplase in78 patients (preliminary) Cohort B single arm standard dose 0.9 mg/kg Ateplase in 330 patients
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Collaborators
- Lumpang Hospital
- Responsible party
- Principal investigator, Dr Subsai Kongsaengdao, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847883
- Sponsor's protocol ID
- Rajavithi Lumphang 001 study
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Versus Standard-dose Ateplase in Acute Ischemic Stroke ; A 4 Months Prospective Randomized Control Pilot Follow by Single Arm Standard Dose Ateplase Study.
- ClinicalTrials.gov ID
- NCT03847883
- Acronym / sponsor ID
- Rajavithi Lumphang 001 study
- Conditions
- Acute Stroke
- Keywords
- Ateplase, Intravenous recombinant tissue plasminogen activator, Acute is hemic stroke, Low-dose Ateplase, rtPa, Modified Rankin 's Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Collaborators
- Lumpang Hospital
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 20 Feb 2019 (actual)
- 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.
Cohort A Randomized Control trial of Ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients Cohort B single arm 0.9 mg/kg Ateplase in 330 patients Combined Cohort A and B evaluate different of death, intra-cerebral hemorrhage, numberof patient with mRS 0-1 at discharge and 3 months follow up, and other important stroke outcomes
Detailed description
We conducted the prospective study to compare the low-dose and standard-dose rtPa and identify the important factors predicted stroke outcomes in acute stroke patient received intravenous rtPa. In Cohort A, During 2011-2012, 78 patients were randomly assigned to received intravenous rtPa 0.6 mg/kg , 0.75 mg/Kg, or 0.9 mg/Kg (1:1:1). After interim analysis during 2012-2017, in Cohort B, 330 patients were assigned to receive standard-dose rtPa 0.9 mg/kg. The good outcomes were defined as improvement of modified Rankin scale (mRS) by final score 0-1 or improvement > 4 points at discharge or 3 months follow up, absent of intracranial hemorrhage within 36 hours treatment, 90-day post-stroke survival , and short hospital length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Cohort A double blind Randomized controlled trial 0.6 or 0.7 or 0.9 mg/Kg Ateplase in78 patients (preliminary) Cohort B single arm standard dose 0.9 mg/kg Ateplase in 330 patients
| Arm | Type | Receives |
|---|---|---|
| 0.6 mg/kg Ateplase | Active comparator | Drug: Intravenous Solution AteplaseLow dose 0.6 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke (n = 26 in cohort A) |
| 0.75 mg/kg Ateplase | Active comparator | Drug: Intravenous Solution AteplaseLow dose 0.75 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A) |
| 0.9 mg/kg Ateplase | Active comparator | Drug: Intravenous Solution AteplaseLow dose 0.9 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A and n= 330 in Cohort B) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Acute ischemic stroke
- Age 18 to 80 years
- Onset of stroke symptoms with in 4.5 hours before initiation of study-drug administration
- Stroke symptoms present for at least 30 minutes with no significant improvement before treatment
Key exclusion criteria (14 listed)
- patients with Intracranial hemorrhage
- the symptoms of Time onset was unknown
- Symptoms rapidly improving or only minor before start of infusion
- Seizure at the onset of stroke
- Stroke or serious head trauma within the previous 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 |
|---|---|---|
| Intravenous Solution AteplaseInfusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke | Drug | 0.6 mg/kg Ateplase, 0.75 mg/kg Ateplase, 0.9 mg/kg Ateplase |
Primary outcome
Death in 36 hours
Time frame: 0-36 hours
Number of patient die in 36 hours
Death in 3 months
Time frame: 0-3 months
Number of patient die in 3 months
Death in 4 months
Time frame: 0-4 months
Number of patient die in 4 months
Total number of patients with mRS 0-1 at discharged
Time frame: 1day to <3 months
Number of patients with mRS 0-1 at discharge 1day to 3 months interval
Total number of patients with mRS 0-1 at 3 months
Time frame: At 3 months
Number of patients with mRS 0-1 at 3 months
Number of patients with All intra-cerebral hemorrhage (ICH) at 36 hours
Time frame: 0- 36 hours
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months
Time frame: 0-3 months
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months
Time frame: 0-4 months
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 36 hours
Time frame: 0-36 hours
Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 4 months
Time frame: 0-4 months
Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 36 hours
Time frame: 0-36 hours
Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 3 months
Time frame: 0-3 months
Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 4 months
Time frame: 0-4 months
Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration
5 secondary outcomes
Good stroke outcomes
Time frame: 0-4 months
Improved mRS at discharge
Time frame: (At discharge) 1 day to 3 months
Improved mRS 3 months
Time frame: At 3 months
Number of patienta with Length of hospital stay (LOS) less than 7 days Days
Time frame: 1- 7 days
All complications
Time frame: 0-4 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 20 Feb 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Solution Ateplase in people with Acute Stroke, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 14 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 20 Feb 2019. 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Death in 36 hours (time frame: 0-36 hours). The study lists 13 primary outcomes in all. 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 20 Feb 2019.