Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China

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

Study Overview

• Status: Withdrawn
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Alteplase; Drug: Urokinase

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 Type: Observational

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • General Hospital of Shenyang Military Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thrombolytic patients with acute ischemic stroke within 3 hours of onset

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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 group; 1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End	Drug: Urokinase; 1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS of 90 days after thrombolysis	Proportion of patients with mRS = 0-1 points 90 days after thrombolysis	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Adverse events	Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding	Year 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic evaluation	The cost-effectiveness of different thrombolytic drugs	Day 14

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Principal Investigator: Huisheng Chen, doctor, Neurology Chief

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: alteplase; urokinase; intravenous thrombolysis
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator
• Other Study ID Numbers: K201707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No