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

NCT03847883 | Completed Phase 4 DMC

• 1 other identifier: Rajavithi Lumphang 001 study
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Stroke

Keywords

Ateplase; Intravenous recombinant tissue plasminogen activator; Acute is hemic stroke; Low-dose Ateplase; rtPa; Modified Rankin 's Scale

Outcome Measures

Primary Outcomes (13)

• Death in 36 hours

  Number of patient die in 36 hours

  0-36 hours

• Death in 3 months

  Number of patient die in 3 months

  0-3 months

• Death in 4 months

  Number of patient die in 4 months

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  0-4 months

Secondary Outcomes (5)

• Good stroke outcomes

  0-4 months

• Improved mRS at discharge

  (At discharge) 1 day to 3 months

• Improved mRS 3 months

  At 3 months

• Number of patienta with Length of hospital stay (LOS) less than 7 days Days

  1- 7 days

• All complications

  0-4 months

Study Arms (3)

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)

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)

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)

Drug: Intravenous Solution Ateplase

Interventions

Intravenous Solution Ateplase DRUG

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

0.6 mg/kg Ateplase; 0.75 mg/kg Ateplase; 0.9 mg/kg Ateplase

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead
• Lumpang Hospital: collaborator

Study Sites (1)

Assistant Professor Subsai Kongsaengdao

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 20, 2019
• Study Start: January 1, 2011
• Primary Completion: December 31, 2018
• Study Completion: February 14, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)