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

Sponsor
Rajavithi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03847883
Collaborator
Lumpang Hospital (Other)
408
Enrollment
1
Location
3
Arms
97.4
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous Solution Ateplase
 Phase 4

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

Study Type:
Interventional
Actual Enrollment :
408 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 patientsCohort 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 (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Feb 14, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 0.6 mg/kg Ateplase

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

Drug: Intravenous Solution Ateplase
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
Active Comparator: 0.75 mg/kg Ateplase

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

Drug: Intravenous Solution Ateplase
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
Active Comparator: 0.9 mg/kg Ateplase

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)

Drug: Intravenous Solution Ateplase
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

Outcome Measures

Primary Outcome Measures

  1. Death in 36 hours [0-36 hours]

    Number of patient die in 36 hours

  2. Death in 3 months [0-3 months]

    Number of patient die in 3 months

  3. Death in 4 months [0-4 months]

    Number of patient die in 4 months

  4. Total number of patients with mRS 0-1 at discharged [1day to <3 months]

    Number of patients with mRS 0-1 at discharge 1day to 3 months interval

  5. Total number of patients with mRS 0-1 at 3 months [At 3 months]

    Number of patients with mRS 0-1 at 3 months

  6. Number of patients with All intra-cerebral hemorrhage (ICH) at 36 hours [0- 36 hours]

    Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH

  7. Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months [0-3 months]

    Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH

  8. Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months [0-4 months]

    Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH

  9. Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 36 hours [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

  10. Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 4 months [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

  11. Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 36 hours [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

  12. Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 3 months [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

  13. Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 4 months [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

Secondary Outcome Measures

  1. Good stroke outcomes [0-4 months]

    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

  2. Improved mRS at discharge [(At discharge) 1 day to 3 months]

    Number of patients with improve mRS after treatment at least 1 Score

  3. Improved mRS 3 months [At 3 months]

    Number of patients with improve mRS after treatment at least 1 Score

  4. Number of patienta with Length of hospital stay (LOS) less than 7 days Days [1- 7 days]

    Number of patients with LOS < 7 days ( patients must survive )

  5. All complications [0-4 months]

    Number of patients with stroke complications after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistant Professor Subsai Kongsaengdao Bangkok Thailand 10400

Sponsors and Collaborators

  • Rajavithi Hospital
  • Lumpang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Subsai Kongsaengdao, Associated Professor, Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT03847883
Other Study ID Numbers:
  • Rajavithi Lumphang 001 study
First Posted:
Feb 20, 2019
Last Update Posted:
Feb 20, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Subsai Kongsaengdao, Associated Professor, Rajavithi Hospital
Ateplase
Intravenous recombinant tissue plasminogen activator
Acute is hemic stroke
Low-dose Ateplase
rtPa
Modified Rankin 's Scale
Additional relevant MeSH terms:
Stroke
Ischemic Stroke

Study Results

No Results Posted as of Feb 20, 2019