| Condition or disease | Intervention/treatment |
|---|---|
| Ischemic Stroke | Drug: Alteplase Drug: Urokinase |
| 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 |
| 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.
|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
| China, Liaoning | |
| General Hospital of Shenyang Military Region | |
| Shenyang, Liaoning, China | |
| 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 |
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 |
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 |
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
|
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| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Thrombolytic patients with acute ischemic stroke within 3 hours of onset | ||||||
| Condition | Ischemic Stroke | ||||||
| Intervention |
|
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| Study Groups/Cohorts |
|
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| 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 |
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:
Exclusion Criteria:
|
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| Sex/Gender |
|
||||||
| 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 |
|
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| IPD Sharing Statement |
|
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| Responsible Party | Hui-Sheng Chen, General Hospital of Shenyang Military Region | ||||||
| Study Sponsor | General Hospital of Shenyang Military Region | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
|
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| PRS Account | General Hospital of Shenyang Military Region | ||||||
| Verification Date | June 2019 | ||||||