Status:
COMPLETED
Low-dose Versus Standard Dose Alteplase in Acute Ischemic Stroke , 4 Monthes Prospective Study
Lead Sponsor:
Department of Medical Services Ministry of Public Health of Thailand
Collaborating Sponsors:
Lumpang Hospital
Conditions:
Acute Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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-c...
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 Coh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2019
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT03847883
Start Date
January 1 2011
End Date
February 14 2019
Last Update
February 20 2019
Active Locations (1)
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1
Assistant Professor Subsai Kongsaengdao
Bangkok, Thailand, 10400