StrokePhase 4ROSE-TNKNCT04752631
MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK
A Phase 4 study testing Tenecteplase in people with Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
This is an open label multicentre trial, evaluating the utility of MRI-guided thrombolysis for stroke beyond time window by Tenecteplase (TNK-tPA). This exploratory study was to describe the feasibility and outcome of thrombolytic therapy with TNK-tPA in 4.5-24 hours after stroke guided by a mismatch between… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Tenecteplase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2021to 24 Jul 2022
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age 18-80 years;
- The time from onset to treatment: 4.5-24 hours;
- Acute Ischemic stroke confirmed by MRI;
- NIHSS score ：6-25, or NIHSS score≤ 5 but culprit vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on CTA/MRA;
- Imaging requirements: (1) DWI infarct region: no more than 1/3 of middle cerebral artery territory or 1/2 of the anterior cerebral artery territory or 1/2 of the posterior cerebral artery territory; (2) DWI infarct volume <70 ml; (2) presence of DWI/Flair mismatch: DWI high signal and Flair visually normal;
- the first onset of ischemic stroke or previous stroke with no obvious sequelae (mRS≤1);
- Signed informed consent
Who cannot join
- Planned endovascular treatment;
- Serious neurological deficits before onset ( mRS ≥ 2);
- Obvious head injuries or strokes within 3 months;
- Subarachnoid hemorrhage;
- History of intracranial hemorrhage;
- Intracranial tumor, arteriovenous malformation or aneurysm;
Show all 28Show fewer
- Intracranial or spinal cord surgery within 3 months;
- Arterial puncture at a noncompressible site within the previous seven days;
- Active internal hemorrhage;
- coagulation abnormalities: platelet count of <100000/mm3 ；
- Aortic arch dissection；
- Heparin therapy within 24 hours;
- Infective endocarditis；
- Oral warfarin is being taken and INR>1.6 or APTT abnormal；
- oral anticoagulation therapy；
- Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg；
- Blood glucose < 50 mg/dl (2.7mmol/L)；
- Pregnancy;
- Neurological deficit after epileptic seizures;
- Major surgery within 1 month;
- Gastrointestinal or urinary tract hemorrhage within the previous 30 days;
- Myocardial infarction within 3 months;
- allergy to study drugs;
- Contradictory to MRI examination；
- MRI image not qualified for evaluation；
- Other serious illness；
- Participating in other clinical trials within 3 months;
- patients not suitable for this clinical studies considered by researcher.
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: MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK (ROSE-TNK): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study
This is an open label multicentre trial, evaluating the utility of MRI-guided thrombolysis for stroke beyond time window by Tenecteplase (TNK-tPA). This exploratory study was to describe the feasibility and outcome of thrombolytic therapy with TNK-tPA in 4.5-24 hours after stroke guided by a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia.
Read the detailed description
In patients with acute stroke with an unknown time of onset, intravenous alteplase guided by a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia resulted in a significantly better functional outcome at 90 days. This trial will enroll acute ischemic stroke patients within 4.5 to 24 hours of onset. All the patients had an ischemic lesion that was visible on MRI diffusion-weighted imaging but no parenchymal hyperintensity on fluid-attenuated inversion recovery (FLAIR), which indicated that the stroke had a ischemic penumbra. Randomization will be 1:1 to TNK-tPA (experimental) or standard treatment (control), in compliance with guidelines for acute stroke. Clinical outcome was assessed by disability on the basis of the modified Rankin scale at 90 days follow-up, which will be performed by a blinded assessor.
- Conditions
- Stroke
- Being tested
- Tenecteplase
- Keywords
- TNK-tPA, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseDrug
Also called TNK-tPA
The participants received TNK-tPA thrombolytic therapy
| Study group | Role | What they receive |
|---|---|---|
| TNK-tPA | Experimental | TNK-tPA (0.25mg/kg) given as a single bolus over 5-10 seconds immediately upon randomization. Receives: Drug: Tenecteplase |
| Routine Therapy | No intervention | Patients will be treated with standard of care in compliance with guidelines for acute stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of modified Rankin Scale (mRS) 0-1
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Measured: 90 Days
Secondary outcomes (5)
Proportion of modified Rankin Scale (mRS) 0-2
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Measured: 90 Days
Distribution of the modified Rankin Scale (mRS)
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Measured: 90 Days
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome
Measured: 24 hours and 1 week
vascular events
The incidence of stroke and other vascular events
Measured: 90 Days
proportion of death
death due to any cause
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start9 Mar 2021
- Primary completion24 Jul 2022
- Study completion24 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 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
- Chen Hui-Sheng, Doctor, Study director, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752631
- Sponsor's protocol ID
- Y(2020)067
- Acronym
- ROSE-TNK
- Status last verified
- Jul 2022
- First submitted
- 9 Feb 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomalla G, Simonsen CZ, Boutitie F, Andersen G, Berthezene Y, Cheng B, Cheripelli B, Cho TH, Fazekas F, Fiehler J, Ford I, Galinovic I, Gellissen S, Golsari A, Gregori J, Gunther M, Guibernau J, Hausler KG, Hennerici M, Kemmling A, Marstrand J, Modrau B, Neeb L, Perez de la Ossa N, Puig J, Ringleb P, Roy P, Scheel E, Schonewille W, Serena J, Sunaert S, Villringer K, Wouters A, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C; WAKE-UP Investigators. MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset. N Engl J Med. 2018 Aug 16;379(7):611-622. doi: 10.1056/NEJMoa1804355. Epub 2018 May 16.
PubMed 29766770
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK (ROSE-TNK): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study
- ClinicalTrials.gov ID
- NCT04752631
- Acronym / sponsor ID
- ROSE-TNK / Y(2020)067
- Conditions
- Stroke
- Keywords
- TNK-tPA, stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 24 Jul 2022 (actual)
- Study completion
- 24 Jul 2022 (actual)
- First posted
- 12 Feb 2021 (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.
This is an open label multicentre trial, evaluating the utility of MRI-guided thrombolysis for stroke beyond time window by Tenecteplase (TNK-tPA). This exploratory study was to describe the feasibility and outcome of thrombolytic therapy with TNK-tPA in 4.5-24 hours after stroke guided by a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia.
Detailed description
In patients with acute stroke with an unknown time of onset, intravenous alteplase guided by a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia resulted in a significantly better functional outcome at 90 days. This trial will enroll acute ischemic stroke patients within 4.5 to 24 hours of onset. All the patients had an ischemic lesion that was visible on MRI diffusion-weighted imaging but no parenchymal hyperintensity on fluid-attenuated inversion recovery (FLAIR), which indicated that the stroke had a ischemic penumbra. Randomization will be 1:1 to TNK-tPA (experimental) or standard treatment (control), in compliance with guidelines for acute stroke. Clinical outcome was assessed by disability on the basis of the modified Rankin scale at 90 days follow-up, which will be performed by a blinded assessor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNK-tPA | Experimental | Drug: TenecteplaseTNK-tPA (0.25mg/kg) given as a single bolus over 5-10 seconds immediately upon randomization. |
| Routine Therapy | No intervention | –Patients will be treated with standard of care in compliance with guidelines for acute stroke |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age 18-80 years;
- The time from onset to treatment: 4.5-24 hours;
- Acute Ischemic stroke confirmed by MRI;
- NIHSS score ：6-25, or NIHSS score≤ 5 but culprit vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on CTA/MRA;
- Imaging requirements: (1) DWI infarct region: no more than 1/3 of middle cerebral artery territory or 1/2 of the anterior cerebral artery territory or 1/2 of the posterior cerebral artery territory; (2) DWI infarct volume <70 ml; (2) presence of DWI/Flair mismatch: DWI high signal and Flair visually normal;
Key exclusion criteria (28 listed)
- Planned endovascular treatment;
- Serious neurological deficits before onset ( mRS ≥ 2);
- Obvious head injuries or strokes within 3 months;
- Subarachnoid hemorrhage;
- History of intracranial hemorrhage;
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 |
|---|---|---|
| TenecteplaseAlso: TNK-tPAThe participants received TNK-tPA thrombolytic therapy | Drug | TNK-tPA |
Primary outcome
Proportion of modified Rankin Scale (mRS) 0-1
Time frame: 90 Days
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
5 secondary outcomes
Proportion of modified Rankin Scale (mRS) 0-2
Time frame: 90 Days
Distribution of the modified Rankin Scale (mRS)
Time frame: 90 Days
Changes in National Institute of Health stroke scale (NIHSS)
Time frame: 24 hours and 1 week
vascular events
Time frame: 90 Days
proportion of death
Time frame: 14 days
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 2 Aug 2022.
- Background: PubMed 29766770Thomalla G, Simonsen CZ, Boutitie F, Andersen G, Berthezene Y, Cheng B, Cheripelli B, Cho TH, Fazekas F, Fiehler J, Ford I, Galinovic I, Gellissen S, Golsari A, Gregori J, Gunther M, Guibernau J, Hausler KG, Hennerici M, Kemmling A, Marstrand J, Modrau B, Neeb L, Perez de la Ossa N, Puig J, Ringleb P, Roy P, Scheel E, Schonewille W, Serena J, Sunaert S, Villringer K, Wouters A, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C; WAKE-UP Investigators. MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset. N Engl J Med. 2018 Aug 16;379(7):611-622. doi: 10.1056/NEJMoa1804355. Epub 2018 May 16.
- 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.
Chen Hui-Sheng, Doctor study director
General Hospital of Shenyang Military Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenecteplase in people with 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 7 inclusion and 28 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 2 Aug 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of modified Rankin Scale (mRS) 0-1 (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752631, which also lists 1 linked publication.
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 2 Aug 2022.