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

Department of Medical Services Ministry of Public Health of Thailand408 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

408

Conditions

Acute Stroke

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Assistant Professor Subsai Kongsaengdao

Bangkok, Thailand

Outcomes

Primary Outcomes

Death in 36 hours

Number of patient die in 36 hours

Time frame: 0-36 hours

Death in 3 months

Number of patient die in 3 months

Time frame: 0-3 months

Death in 4 months

Number of patient die in 4 months

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 0-4 months

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

Data from ClinicalTrials.gov

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Secondary Outcomes

Good stroke outcomes

Total number of patients with "good outcomes" were defined as number of patients with this any one item criteria 1. improvement of modified Rankin scale (mRS) by final score 0-1 2. 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

Improved mRS at discharge

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

Time frame: (At discharge) 1 day to 3 months

Improved mRS 3 months

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

Time frame: 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 )

Time frame: 1- 7 days

All complications

Number of patients with stroke complications after treatment

Time frame: 0-4 months