Trial | NCT03847883  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    408
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 Started
Jan 01
2011
Primary Completion
Dec 31
2018
Study Completion
Feb 14
2019
Last Update
Feb 20
2019

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

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)

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)

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)

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
No Results Posted