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Low-dose Versus Standard Dose Alteplase in Acute Ischemic Stroke , 4 Monthes Prospective Study

Primary Purpose

Acute Stroke

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Intravenous Solution Ateplase
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Ateplase, Intravenous recombinant tissue plasminogen activator, Acute is hemic stroke, Low-dose Ateplase, rtPa, Modified Rankin 's Scale

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of Acute ischemic stroke
  2. Age 18 to 80 years
  3. Onset of stroke symptoms with in 4.5 hours before initiation of study-drug administration
  4. Stroke symptoms present for at least 30 minutes with no significant improvement before treatment

Exclusion Criteria:

  1. patients with Intracranial hemorrhage
  2. the symptoms of Time onset was unknown
  3. Symptoms rapidly improving or only minor before start of infusion
  4. Seizure at the onset of stroke
  5. Stroke or serious head trauma within the previous 3 months
  6. Administration of heparin within the 48 hours preceding the onset of stroke, with an activate
  7. partial-thromboplastin time at presentation exceeding the upper limit of the normal range
  8. Platelet count of less than 100,000 per cubic millimeter
  9. 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
  10. Blood glucose less than 50 mg per deciliter or greater than 400 mg per deciliter
  11. Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
  12. Oral anticoagulant treatment
  13. Major surgery or severe trauma within the previous 3 months
  14. Other major disorders associated with an increased risk of bleeding

Sites / Locations

  • Assistant Professor Subsai Kongsaengdao

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

0.6 mg/kg Ateplase

0.75 mg/kg Ateplase

0.9 mg/kg Ateplase

Arm Description

Low dose 0.6 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke (n = 26 in cohort A)

Low dose 0.75 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A)

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)

Outcomes

Primary Outcome Measures

Death in 36 hours
Number of patient die in 36 hours
Death in 3 months
Number of patient die in 3 months
Death in 4 months
Number of patient die in 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
Total number of patients with mRS 0-1 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
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
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
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
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
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
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

Secondary Outcome Measures

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 1) 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
Improved mRS at discharge
Number of patients with improve mRS after treatment at least 1 Score
Improved mRS 3 months
Number of patients with improve mRS after treatment at least 1 Score
Number of patienta with Length of hospital stay (LOS) less than 7 days Days
Number of patients with LOS < 7 days ( patients must survive )
All complications
Number of patients with stroke complications after treatment

Full Information

First Posted
February 15, 2019
Last Updated
February 19, 2019
Sponsor
Rajavithi Hospital
Collaborators
Lumpang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03847883
Brief Title
Low-dose Versus Standard Dose Alteplase in Acute Ischemic Stroke , 4 Monthes Prospective 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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
February 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajavithi Hospital
Collaborators
Lumpang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Ateplase, Intravenous recombinant tissue plasminogen activator, Acute is hemic stroke, Low-dose Ateplase, rtPa, Modified Rankin 's Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.6 mg/kg Ateplase
Arm Type
Active Comparator
Arm Description
Low dose 0.6 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke (n = 26 in cohort A)
Arm Title
0.75 mg/kg Ateplase
Arm Type
Active Comparator
Arm Description
Low dose 0.75 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A)
Arm Title
0.9 mg/kg Ateplase
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Intravenous Solution Ateplase
Intervention Description
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
Primary Outcome Measure Information:
Title
Death in 36 hours
Description
Number of patient die in 36 hours
Time Frame
0-36 hours
Title
Death in 3 months
Description
Number of patient die in 3 months
Time Frame
0-3 months
Title
Death in 4 months
Description
Number of patient die in 4 months
Time Frame
0-4 months
Title
Total number of patients with mRS 0-1 at discharged
Description
Number of patients with mRS 0-1 at discharge 1day to 3 months interval
Time Frame
1day to <3 months
Title
Total number of patients with mRS 0-1 at 3 months
Description
Number of patients with mRS 0-1 at 3 months
Time Frame
At 3 months
Title
Number of patients with All intra-cerebral hemorrhage (ICH) at 36 hours
Description
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Time Frame
0- 36 hours
Title
Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months
Description
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Time Frame
0-3 months
Title
Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months
Description
Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH
Time Frame
0-4 months
Title
Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 36 hours
Description
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
Time Frame
0-36 hours
Title
Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 4 months
Description
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
Time Frame
0-4 months
Title
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 36 hours
Description
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
Time Frame
0-36 hours
Title
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 3 months
Description
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
Time Frame
0-3 months
Title
Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 4 months
Description
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
Time Frame
0-4 months
Secondary Outcome Measure Information:
Title
Good stroke outcomes
Description
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 1) 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
Time Frame
0-4 months
Title
Improved mRS at discharge
Description
Number of patients with improve mRS after treatment at least 1 Score
Time Frame
(At discharge) 1 day to 3 months
Title
Improved mRS 3 months
Description
Number of patients with improve mRS after treatment at least 1 Score
Time Frame
At 3 months
Title
Number of patienta with Length of hospital stay (LOS) less than 7 days Days
Description
Number of patients with LOS < 7 days ( patients must survive )
Time Frame
1- 7 days
Title
All complications
Description
Number of patients with stroke complications after treatment
Time Frame
0-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Facility Information:
Facility Name
Assistant Professor Subsai Kongsaengdao
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Low-dose Versus Standard Dose Alteplase in Acute Ischemic Stroke , 4 Monthes Prospective Study

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