Stroke AcuteTRANSITNCT06621121
A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke
An observational study of Stroke Acute and Tenecteplase, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
Stroke is the second leading cause of death worldwide, killing nearly 7 million people every year. Acute ischemic stroke is caused by focal cerebral hypoperfusion, usually due to embolism or atherosclerotic disease . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute, Tenecteplase, Alteplase
- What is being tested?
- Tenecteplase and Alteplase
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2024to 1 Oct 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke within 4.5 hours last known well (including wake-up stroke and no witness stroke )were included in the study.
Who may be able to join
- 1. Symptoms of neurological deficit caused by ischemic stroke; 2. The time from onset to treatment ≤4.5 hours; The time of onset of symptoms was defined as the time of last seen normal.
- 3. Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative.
Who cannot join
- 1. Any absolute contraindication to thrombolysis in the \"Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023\" 2.Allergy to TNK or alteplase 3.Participation in another clinical trial within the previous 3 months. 4.Other conditions deemed inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300350
shoufengliu Liu, MD, +86 13920017229, shoufengliu2010@163.com
About this study
Official title: Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke : a Multicenter, Prospective, Observational, Real-world Study（TRANSIT）
Stroke is the second leading cause of death worldwide, killing nearly 7 million people every year. Acute ischemic stroke is caused by focal cerebral hypoperfusion, usually due to embolism or atherosclerotic disease . Ischemic strokes account for 60-70% of all strokes worldwide and are severely debilitating, drawing considerable attention due to their high prevalence.The majority of studies comparing the efficacy and safety of teneplase and alteplase are predominantly randomized controlled trials with limited representation from real-world studies.The aim of this study is to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in clinical practice. This study aimed to establish a foundation for refining intravenous thrombolytic therapy tailored to various patient profiles and to guide clinicians in selecting the most suitable thrombolytic treatment options.
Read the detailed description
TRANSIT is a prospective, multicenter, open-label real world study.The purpose of this study was to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in practical clinical applications. To provide the basis for optimizing the intravenous thrombolysis program for different types of patients, and to provide a reference for clinicians to choose the appropriate thrombolytic therapy program.
6000 individuals who met the indications for intravenous thrombolysis and signed informed consent were included.The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, or alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families. Assessments were conducted at baseline, as well as at 24, 36, and 72 hours post-thrombolysis. Follow-up evaluations were performed on day 7 (or prior to discharge) and day 90.The primary efficacy endpoint was the proportion of excellent functional outcomes at 90±7 days (modified Rankin Scale score, mRS 0 or 1).The primary safety outcome was the proportion of sICH within 36 h (as defined by The European Cooperative Acute Stroke Study III criteria).The economic endpoint included the total costs of the first hospitalization and the days at home within 90±7 days.
- Conditions
- Stroke Acute, Tenecteplase, Alteplase
- Being tested
- Tenecteplase, Alteplase
- Keywords
- ischemic stroke, tenecteplase, alteplase
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseOther
The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, based on their clinical condition and the preferences expressed by the patients and their families.
AlteplaseOther
The enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families.
| Study group | Role | What they receive |
|---|---|---|
| TNK group | The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg. Receives: Other: Tenecteplase | |
| rtPA group | The enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg. Receives: Other: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS
The primary efficacy endpoint is the proportion of excellent functional outcome at 90±7 days (modified Rankin Scale score, mRS 0 or 1).The modified Rankin Scale is commonly used to measure neurological recovery after stroke on a scale of 0-6, with higher scores associated with worse outcomes .
Measured: 90±7 days after enrollment
Secondary outcomes (7)
NIHSS score
Incidence of neurological improvement at 72h after treatment (proportion of subjects with NIHSS score ≤1 point or 8 points or more lower than baseline )
Measured: 72h after treatment
proportion of sICH
The safety outcome is the proportion of sICH within 36 hours (as defined by The European Cooperative Acute Stroke Study III criteria）
Measured: 36h after treatment
rate of death
Secondary safety end points related to Rate of death from any cause within and Rate of systemic bleeding within 90 days.
Measured: 90 days after enrollment
mRS
Improvement of mRS Scores at 90±7 days (shift analysis)
Measured: 90±7 days after enrollment
mRS
The proportion of favourable functional outcome at 90±7 days (mRS 0-2)
Measured: 90±7 days after enrollment
NIHSS score
Incidence of Neurological deterioration at 7±1 days (NIHSS score increased by ≥2 points and cerebral hemorrhage was excluded)
Measured: 7±1 days after enrollment
stroke recurrence
Incidence of stroke recurrence and other vascular events at 90±7 days.
Measured: 90±7 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start26 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialing Wu, Tianjin Huanhu Hospital
- Investigators
- Jialing Wu, MD,PhD, Principal investigator, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621121
- Sponsor's protocol ID
- WJL-2024-10
- Acronym
- TRANSIT
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke : a Multicenter, Prospective, Observational, Real-world Study（TRANSIT）
- ClinicalTrials.gov ID
- NCT06621121
- Acronym / sponsor ID
- TRANSIT / WJL-2024-10
- Conditions
- Stroke Acute, Tenecteplase, Alteplase
- Keywords
- ischemic stroke, tenecteplase, alteplase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 26 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
Stroke is the second leading cause of death worldwide, killing nearly 7 million people every year. Acute ischemic stroke is caused by focal cerebral hypoperfusion, usually due to embolism or atherosclerotic disease . Ischemic strokes account for 60-70% of all strokes worldwide and are severely debilitating, drawing considerable attention due to their high prevalence.The majority of studies comparing the efficacy and safety of teneplase and alteplase are predominantly randomized controlled trials with limited representation from real-world studies.The aim of this study is to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in clinical practice. This study aimed to establish a foundation for refining intravenous thrombolytic therapy tailored to various patient profiles and to guide clinicians in selecting the most suitable thrombolytic treatment options.
Detailed description
TRANSIT is a prospective, multicenter, open-label real world study.The purpose of this study was to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in practical clinical applications. To provide the basis for optimizing the intravenous thrombolysis program for different types of patients, and to provide a reference for clinicians to choose the appropriate thrombolytic therapy program.
6000 individuals who met the indications for intravenous thrombolysis and signed informed consent were included.The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, or alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families. Assessments were conducted at baseline, as well as at 24, 36, and 72 hours post-thrombolysis. Follow-up evaluations were performed on day 7 (or prior to discharge) and day 90.The primary efficacy endpoint was the proportion of excellent functional outcomes at 90±7 days (modified Rankin Scale score, mRS 0 or 1).The primary safety outcome was the proportion of sICH within 36 h (as defined by The European Cooperative Acute Stroke Study III criteria).The economic endpoint included the total costs of the first hospitalization and the days at home within 90±7 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNK group | – | Other: TenecteplaseThe enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg. |
| rtPA group | – | Other: AlteplaseThe enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke within 4.5 hours last known well (including wake-up stroke and no witness stroke )were included in the study.
Key inclusion criteria (2 listed)
- 1. Symptoms of neurological deficit caused by ischemic stroke; 2. The time from onset to treatment ≤4.5 hours; The time of onset of symptoms was defined as the time of last seen normal.
- 3. Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative.
Key exclusion criteria (1 listed)
- 1. Any absolute contraindication to thrombolysis in the \"Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023\" 2.Allergy to TNK or alteplase 3.Participation in another clinical trial within the previous 3 months. 4.Other conditions deemed inappropriate for participation in this study.
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 |
|---|---|---|
| TenecteplaseThe enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, based on their clinical condition and the preferences expressed by the patients and their families. | Other | TNK group |
| AlteplaseThe enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families. | Other | rtPA group |
Primary outcome
mRS
Time frame: 90±7 days after enrollment
The primary efficacy endpoint is the proportion of excellent functional outcome at 90±7 days (modified Rankin Scale score, mRS 0 or 1).The modified Rankin Scale is commonly used to measure neurological recovery after stroke on a scale of 0-6, with higher scores associated with worse outcomes .
7 secondary outcomes
NIHSS score
Time frame: 72h after treatment
proportion of sICH
Time frame: 36h after treatment
rate of death
Time frame: 90 days after enrollment
mRS
Time frame: 90±7 days after enrollment
mRS
Time frame: 90±7 days after enrollment
NIHSS score
Time frame: 7±1 days after enrollment
stroke recurrence
Time frame: 90±7 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Jialing Wu, MD,PhD principal investigator
Tianjin Huanhu Hospital
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 Acute and Tenecteplase, run by Tianjin Huanhu Hospital 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shoufeng Liu, MD (400-802-7885, shoufengliu2010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS (time frame: 90±7 days after enrollment). 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 29 Oct 2024.