Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

Withdrawn

• Conditions: Ischemic Stroke
• Interventions: Drug: Alteplase; Drug: Urokinase

• Registration Number: NCT03997292
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China

Detailed Description

Compare the efficacy and safety of different thrombolytic drugs; Analysis of patients during hospital treatment of adverse events and complications; Analysis of factors that affect the effectiveness of treatment; Evaluate the pharmacological benefits of different thrombolytic drugs

Study Timeline

• Study First Submitted: 2017-11-14
• Study Start: 2018-03-01
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-21
• Study First Posted: 2019-06-25
• Last Update Posted: 2019-06-25
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 1. age> 18 years old;
• 2. meet the diagnostic criteria of China 2014 guidelines for the diagnosis and treatment of acute ischemic stroke;
• 3. no history of first sepsis or previous cerebral infarction sequelae (mRS ≤ 1);
• 4. within 3 hours of onset;
• 5. Have measurable neurological deficits;
• 6. Patients or legal guardians can understand and sign informed consent.

Exclusion Criteria

• Absolute exclusion criteria:
• 1. history of head trauma or stroke within the last 3 months;
• 2. suspected subarachnoid hemorrhage;
• 3. history of previous intracranial hemorrhage;
• 4. intracranial tumor, arteriovenous malformation or aneurysm ;
• 5. recent intracranial or intraspinal surgery;
• 6. arterial puncture at an incurable site within the last 7 days;
• 7. elevated blood pressure: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
• 8. Internal bleeding;
• 9. acute bleeding tendency, including platelet count less than 100 × 109 / L or other conditions;
• 10. heparin treatment within 48 h (APTT is outside the upper limit of normal range);
• 11. oral anticoagulant, INR> 1.7 Or PT> 15S;
• 12. are currently using thrombin inhibitors or factor Xa inhibitors, various sensitive laboratory abnormalities (such as APTT, INR, platelet count, ECT; TT or appropriate factor Xa activity assays) ;
• 13. Blood glucose <50 mg / dl (2.7 mmol / L);
• 14. CT suggestive of multiple cerebral infarction (low density range> 1/3 of the cerebral hemispheres) ;
• 15. Other conditions considered unsuitable for inclusion in this clinical study;
• 16. 3 months or are participating in other clinical trials;
• 17. combined with severe systemic disease is expected to survive less than three months.
• Relative exclusion criteria:
• 1. severe stroke (NIHSS> 25 points);
• 2. pregnancy;
• 3. neurological deficits after epileptic seizures;
• 4. major surgery or severe trauma within the last 14 days;
• 5. Urethral hemorrhage;
• 6. Myocardial infarction within the last 3 months;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alteplase group	Alteplase	According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion
Urokinase group	Urokinase	1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End

Primary Outcome Measures

Name	Time	Method
mRS of 90 days after thrombolysis	Month 3	Proportion of patients with mRS = 0-1 points 90 days after thrombolysis

Secondary Outcome Measures

Name	Time	Method
Evaluation of Adverse events	Year 1	Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding

Trial Locations

Locations (1)

General Hospital of Shenyang Military Region; 🇨🇳 Shenyang, Liaoning, China