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

• Status: Completed
• Trial end date: 2019-02-14
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rajavithi Hospital
• Collaborator: Lumpang Hospital

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