Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

NCT ID: NCT03997292

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-09-01

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

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Alteplase group

According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion

Alteplase

Intervention Type: DRUG

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

1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End

Urokinase

Intervention Type: DRUG

1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.

Interventions

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.

Intervention Type: DRUG

Urokinase

1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.

Intervention Type: DRUG

Eligibility Criteria

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

• 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.
• 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Neurology Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huisheng Chen, doctor

Role: PRINCIPAL_INVESTIGATOR

Neurology Chief

Locations

General Hospital of Shenyang Military Region

Shenyang, Liaoning, China

Countries

China

Other Identifiers

K201707

Identifier Type: -

Identifier Source: org_study_id