Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Withdrawn

Conditions: Ischemic Stroke

Treatments: Drug: Alteplase; Drug: Urokinase

Study type: Observational

Funder types: Other

Identifiers

NCT03997292

K201707

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

0 participants in 2 patient groups

Alteplase group

Description:

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

Treatment:

Drug: Alteplase

Urokinase group

Description:

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

Treatment:

Drug: Urokinase