Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

Ischemic Stroke Clinical Trial

Official title:

Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03997292
• Other study ID #: K201707
• Status: Withdrawn
• Start date: March 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: June 2019
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of Shenyang Military Region	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic evaluation	The cost-effectiveness of different thrombolytic drugs	Day 14
Primary	mRS of 90 days after thrombolysis	Proportion of patients with mRS = 0-1 points 90 days after thrombolysis	Month 3
Secondary	Evaluation of Adverse events	Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding	Year 1