Ischemic StrokeNCT03997292
Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China
An observational study of Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Alteplase and Urokinase
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thrombolytic patients with acute ischemic stroke within 3 hours of onset
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China
To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China
Read the 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
- Conditions
- Ischemic Stroke
- Being tested
- Alteplase, Urokinase
- Keywords
- alteplase; urokinase; intravenous thrombolysis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion.
UrokinaseDrug
1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Alteplase | |
| Urokinase group | 1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End Receives: Drug: Urokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS of 90 days after thrombolysis
Proportion of patients with mRS = 0-1 points 90 days after thrombolysis
Measured: Month 3
Secondary outcomes (1)
Evaluation of Adverse events
Symptomatic intracranial hemorrhage conversion rate; Liver and kidney dysfunction; Bleeding gums; Skin mucous membrane bleeding
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Mar 2018 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Why it stopped: The study has been terminated due to key change of protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- Huisheng Chen, doctor, Principal investigator, Neurology Chief
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997292
- Sponsor's protocol ID
- K201707
- Status last verified
- Jun 2019
- First submitted
- 14 Nov 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China
- ClinicalTrials.gov ID
- NCT03997292
- Acronym / sponsor ID
- K201707
- Conditions
- Ischemic Stroke
- Keywords
- alteplase; urokinase; intravenous thrombolysis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study has been terminated due to key change of protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alteplase group | – | Drug: AlteplaseAccording 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 | – | Drug: Urokinase1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thrombolytic patients with acute ischemic stroke within 3 hours of onset
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (25 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlteplaseAccording 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 group |
| Urokinase1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously. | Drug | Urokinase group |
Primary outcome
mRS of 90 days after thrombolysis
Time frame: Month 3
Proportion of patients with mRS = 0-1 points 90 days after thrombolysis
1 secondary outcome
Evaluation of Adverse events
Time frame: Year 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huisheng Chen, doctor principal investigator
Neurology Chief
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS of 90 days after thrombolysis (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.