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出境医 / 临床实验 / Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

Study Description
Brief Summary:
To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China

Condition or disease Intervention/treatment
Ischemic Stroke 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 Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020
Arms 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.

Outcome Measures
Primary Outcome Measures :
  1. mRS of 90 days after thrombolysis [ Time Frame: Month 3 ]
    Proportion of patients with mRS = 0-1 points 90 days after thrombolysis


Secondary Outcome Measures :
  1. Evaluation of Adverse events [ Time Frame: Year 1 ]
    Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding


Other Outcome Measures:
  1. Economic evaluation [ Time Frame: Day 14 ]
    The cost-effectiveness of different thrombolytic drugs


Biospecimen Retention:   Samples With DNA
blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Thrombolytic patients with acute ischemic stroke within 3 hours of onset
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:

  • 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;
Contacts and Locations

Locations
Layout table for location information
China, Liaoning
General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
Layout table for investigator information
Principal Investigator: Huisheng Chen, doctor Neurology Chief
Tracking Information
First Submitted Date November 14, 2017
First Posted Date June 25, 2019
Last Update Posted Date June 25, 2019
Estimated Study Start Date March 1, 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2019)
mRS of 90 days after thrombolysis [ Time Frame: Month 3 ]
Proportion of patients with mRS = 0-1 points 90 days after thrombolysis
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 21, 2019)
Evaluation of Adverse events [ Time Frame: Year 1 ]
Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2019)
Economic evaluation [ Time Frame: Day 14 ]
The cost-effectiveness of different thrombolytic drugs
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China
Official Title Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood
Sampling Method Non-Probability Sample
Study Population Thrombolytic patients with acute ischemic stroke within 3 hours of onset
Condition Ischemic 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.
  • Drug: Urokinase
    1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.
Study Groups/Cohorts
  • 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
    Intervention: Drug: Alteplase
  • Urokinase group
    1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End
    Intervention: Drug: Urokinase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: June 21, 2019)
0
Original Actual Enrollment Same as current
Estimated Study Completion Date September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
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:

  • 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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03997292
Other Study ID Numbers K201707
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Hui-Sheng Chen, General Hospital of Shenyang Military Region
Study Sponsor General Hospital of Shenyang Military Region
Collaborators Not Provided
Investigators
Principal Investigator: Huisheng Chen, doctor Neurology Chief
PRS Account General Hospital of Shenyang Military Region
Verification Date June 2019