Clinical trial NCT03847883: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Stroke
Keywords: Ateplase
Intravenous recombinant tissue plasminogen activator
Acute is hemic stroke
Low-dose Ateplase
rtPa
Modified Rankin 's Scale
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Lumpang Hospital
First posted: 2019-02-20
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 patients
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death in 36 hours
timeFrame: 0-36 hours
measure: Death in 3 months
timeFrame: 0-3 months
measure: Death in 4 months
timeFrame: 0-4 months
measure: Total number of patients with mRS 0-1 at discharged
timeFrame: 1day to <3 months
measure: Total number of patients with mRS 0-1 at 3 months
timeFrame: At 3 months
measure: Number of patients with All intra-cerebral hemorrhage (ICH) at 36 hours
timeFrame: 0- 36 hours
measure: Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months
timeFrame: 0-3 months
measure: Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months
timeFrame: 0-4 months
measure: Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 36 hours
timeFrame: 0-36 hours
measure: Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 4 months
timeFrame: 0-4 months
measure: Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 36 hours
timeFrame: 0-36 hours
measure: Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 3 months
timeFrame: 0-3 months
measure: Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 4 months
timeFrame: 0-4 months
Secondary outcomes:
measure: Good stroke outcomes
timeFrame: 0-4 months
measure: Improved mRS at discharge
timeFrame: (At discharge) 1 day to 3 months
measure: Improved mRS 3 months
timeFrame: At 3 months
measure: Number of patienta with Length of hospital stay (LOS) less than 7 days Days
timeFrame: 1- 7 days
measure: All complications
timeFrame: 0-4 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Assistant Professor Subsai Kongsaengdao
Study officials:
References: