Stroke, IschemicNCT04588337
INtravenous TNK for Acute isChemicsTroke in China
An observational study of Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Acute ischemic stroke is the most common type of stroke, accounting for about 60%-80% of all stroke, with high incidence, high mortality, high disability rate, has become the first cause of death in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- rhTNK-tPA
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2022to 9 Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: acute ischemic stroke patients who is eligible for intravenous thrombolysis
Who may be able to join
- Age ≥18 ;
- The time from onset to treatment was less than 4.5 hours;
- Ischemic stroke confirmed by head CT or MRI;
- There are measurable neurological deficits;
- First onset or previous onset without obvious sequelae (Mrs ≤1 score) ;
- signed informed consent.
Who cannot join
- Severe neurologic deficits before onset (mRS ≥2) ;
- Significant head trauma or stroke in the last 3 months;
- Subarachnoid hemorrhage;
- A history of intracranial hemorrhage or head injury or acute stroke within 3 months;
- Intracranial tumors, arteriovenous malformations or aneurysms;
- Intracranial or spinal cord surgery within 3 months;
Show all 18Show fewer
- Non-compressible arterial puncture within 7 days;
- Gastrointestinal or urinary tract hemorrhage within last 21 days;
- Major surgery within 1 month;
- Thrombocytopenia (platelet count <10×109/L);
- Use of heparin or oral anticoagulation therapy within 48 hours;
- Use of warfarin with an international normalised ratio >1.7 or PT >15 s;
- Uncontrolled hypertension (SYSTOLIC >180 mmHg OR DIASTOLIC>110 mmHg) ;
- The Blood Glucose concentration <50 mg/dl (2.7 mmol/L);
- Severe systemic disease with poor life expectancy (<3 months); ;
- Allergic to research drug;
- Within 3 months or participating in other clinical trials;
- Other conditions due to which investigators consider study participation inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
About this study
Official title: INtravenous TNK for Acute isChemicsTroke in China (INTACT-China): a Prospective, Multi-center, Registry Study
Acute ischemic stroke is the most common type of stroke, accounting for about 60%-80% of all stroke, with high incidence, high mortality, high disability rate, has become the first cause of death in China. At present, only ultra-early thrombolytic therapy, endovascular therapy and antiplatelet therapy have obtained evidence-based medical evidence in ischemic stroke treatment, but only thrombolytic therapy and endovascular therapy can improve the good prognosis of patients. Intravenous thrombolytic therapy within 4.5 hours after the onset of ischemic stroke symptoms has been shown to be effective, which is recommended in the guidelines.
In most countries, alteplase (R-tPA) is the only drug approved for the treatment of acute ischemic stroke. Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) is a modified recombinant tissue-type plasminogen activator, with no procoagulant effect and a longer half life. In recent years, there are some studies on the comparison of therapeutic effects of TNK-tPA and RT-PA in patients with acute ischemic stroke, and TNK shows promising especially for large artery occlussion. At present, there are few reports on the application of rhTNK-tPA in Chinese stroke patients.
The aim of this study is to evaluate the efficacy and safety of rhTNK-tPA in Chinese patients with ischemic stroke in a prospective, multicenter registration study.
- Conditions
- Stroke, Ischemic
- Being tested
- rhTNK-tPA
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTNK-tPADrug
Thrombolysis
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of excellent prognosis (mRS 0-1)
The proportion of excellent prognosis (mRS 0-1) after thrombolysis
Measured: 90 ± 7 days
Secondary outcomes (4)
the proportion of good prognosis (mRS 0-2)
The proportion of good prognosis (mRS 0-2) after thrombolysis
Measured: 90 ± 7 days
The incidence of stroke deterioration after thrombolysis
NIHSS score increased by more than 2, excluding cerebral hemorrhage
Measured: within 1 week
the incidence of stroke recurrence and other vascular events
the incidence of stroke recurrence and other vascular events within 90 ± 7 days after thrombolysis
Measured: within 90 ± 7 days
symptomatic intracerebral hemorrhage
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
Measured: within 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start6 Jan 2022
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- 1,000 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588337
- Sponsor's protocol ID
- y2020-022
- Status last verified
- Apr 2024
- First submitted
- 3 Oct 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtravenous TNK for Acute isChemicsTroke in China (INTACT-China): a Prospective, Multi-center, Registry Study
- ClinicalTrials.gov ID
- NCT04588337
- Acronym / sponsor ID
- y2020-022
- Conditions
- Stroke, Ischemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 19 Oct 2020 (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.
Acute ischemic stroke is the most common type of stroke, accounting for about 60%-80% of all stroke, with high incidence, high mortality, high disability rate, has become the first cause of death in China. At present, only ultra-early thrombolytic therapy, endovascular therapy and antiplatelet therapy have obtained evidence-based medical evidence in ischemic stroke treatment, but only thrombolytic therapy and endovascular therapy can improve the good prognosis of patients. Intravenous thrombolytic therapy within 4.5 hours after the onset of ischemic stroke symptoms has been shown to be effective, which is recommended in the guidelines.
In most countries, alteplase (R-tPA) is the only drug approved for the treatment of acute ischemic stroke. Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) is a modified recombinant tissue-type plasminogen activator, with no procoagulant effect and a longer half life. In recent years, there are some studies on the comparison of therapeutic effects of TNK-tPA and RT-PA in patients with acute ischemic stroke, and TNK shows promising especially for large artery occlussion. At present, there are few reports on the application of rhTNK-tPA in Chinese stroke patients.
The aim of this study is to evaluate the efficacy and safety of rhTNK-tPA in Chinese patients with ischemic stroke in a prospective, multicenter registration study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- acute ischemic stroke patients who is eligible for intravenous thrombolysis
Key inclusion criteria (6 listed)
- Age ≥18 ;
- The time from onset to treatment was less than 4.5 hours;
- Ischemic stroke confirmed by head CT or MRI;
- There are measurable neurological deficits;
- First onset or previous onset without obvious sequelae (Mrs ≤1 score) ;
Key exclusion criteria (18 listed)
- Severe neurologic deficits before onset (mRS ≥2) ;
- Significant head trauma or stroke in the last 3 months;
- Subarachnoid hemorrhage;
- A history of intracranial hemorrhage or head injury or acute stroke within 3 months;
- Intracranial tumors, arteriovenous malformations or aneurysms;
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 |
|---|---|---|
| rhTNK-tPAThrombolysis | Drug | – |
Primary outcome
The proportion of excellent prognosis (mRS 0-1)
Time frame: 90 ± 7 days
The proportion of excellent prognosis (mRS 0-1) after thrombolysis
4 secondary outcomes
the proportion of good prognosis (mRS 0-2)
Time frame: 90 ± 7 days
The incidence of stroke deterioration after thrombolysis
Time frame: within 1 week
the incidence of stroke recurrence and other vascular events
Time frame: within 90 ± 7 days
symptomatic intracerebral hemorrhage
Time frame: within 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke, Ischemic, 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 18 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: finished, as of the sponsor's last update on 10 Apr 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of excellent prognosis (mRS 0-1) (time frame: 90 ± 7 days). 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 10 Apr 2024.