ischemic stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Acute ischemic stroke; 2. Age, 18 to 80 years; 3. On of stroke symptoms within 4.5 hours before initiation of rt-PA administration; 4. Stroke symptoms present for at least 30 minutes with no significant improvement before treatment.
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhage; 2. Brain swelling or parenchymal hypoattenuation exceeding a third of the middle cerebral artery territory; 3. Time of symptom on unknown; 4. Symptoms rapidly improving or only minor before start of infusion; 5. Administration of heparin within the 48 hours preceding the on of stroke, with an APTT at presentation exceeding theper limit of the normal range; 6. Platelet count of less than 100, 000 per cubic millimeter; 7. Systolic pressure greater than 185mmHg or diastolic pressure greater than 110mmHg, or aggressive treatment (intravenous medication) necesry to reduce blood pressure to these limits; 8. Blood glucose less than 50mg per deciliter or greater than 400mg per deciliter; 9. Oral anticoagulant treatment, INR>1.5; 10. Known hereditary or acquired haemorrhagic diathesis (eg, APTT or PT greater than normal, uncorrected coagulation-factor deficiency, or haemorrhagic retinopathy); 11. Lactation or pregnancy or recent parturition within the previous 30 days; 12. Major surgery or severe trauma or any traumatic brain injury within the previous 14 days; 13. Haemorrhage of the gastrointestinal or urinary tract within the previous 3 months; 14. Arterial puncture at a non-compressible site within the previous 7 days; 15. Other major disorders associated with an increased risk of bleeding; 16. Other life threatening illness (eg, advanced cancer) likely to lead to death within a few months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptomatic intracranial hemorrhage;90d mortality;90d functional independence;90d excellent recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| intracranial hemorrhage;7d mortality;7d functional independence;7d excellent recovery;Early neurological improvement;Early neurological deterioration; | — |
Countries
China