Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset

• Status: Completed
• Trial end date: 2019-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Stroke is one of the leading causes of death and disability in China. Intravenous thrombolysis with recombinant tissue plasminogen activator (rtPA) improves the outcome for ischemic stroke patients who can be treated within 4.5 hours of symptom onset. In China, in addition to rt-PA, intravenous urokinase within 6 h has also been recommended by the 2010 Chinese Guidelines for the Diagnosis and Treatment of Patients with Acute Ischemic Stroke, and supported by evidence from two intravenous urokinase thrombolysis trials. Urokinase is used more frequently than rt-PA, mainly because it is cheaper. To describe Chinese experience with thrombolytic therapy for Ischemic Stroke within 4.5h onset, we designed a multicenter, prospective, registry study. The aim of INtravenous Thrombolysis REgistry for Chinese Ischemic Stroke within 4.5 h onset（INTRECIS）was to assess the safety and efficacy of intravenous rtPA, urokinase as thrombolytic therapy within the first 4.5 h of onset of acute ischaemic stroke.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: General Hospital of Shenyang Military Region
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• ischemic stroke diagnosed by CT or MRI

• first stroke onset or past stroke without obvious neurological deficit (mRS≤1)

• Time from onset to treatment: ≤ 4.5 hours

• Treatment with intravenous rtPA or urokinase

• Signed informed consent by patient self or legally authorized representatives

Exclusion Criteria:

• History of subarachnoid hemorrhage, intracranial hemorrhage and hemorrhagic cerebral infarction

• Obvious head injuries or strokes within 3 months

• Intracranial tumor, arteriovenous malformation or aneurysm

• Intracranial or spinal cord surgery within 3 months

• Gastrointestinal or urinary tract hemorrhage within the previous 21 days

• Blood glucose < 50 mg/dl (2.7mmol/L)

• Heparin therapy or oral anticoagulation therapy within 48 hours

• Oral warfarin is being taken and INR>1.6

• Severe systemic disease which is expected to survive less than 3 months

• Major surgery within 1 month

• Uncontrolled hypertension (>180/100 mmHg)

• Platelet count < 10×109／L

• Patients who have been involved in other clinical trials within 3 months