Stroke, AcuteTETRISNCT05534360
Tenecteplase Treatment in Ischemic Stroke Registry
An observational study of Stroke, Acute, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- Type of treatment
- Injection or infusion
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2022to Mar 2028
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All consecutive adult patients with an acute arterial ischemic stroke who received intravenous thrombolysis with tenecteplase in the participating centers.
Who may be able to join
- Age 18 and older
- Confirmed acute arterial ischemic stroke on brain imaging (CT or MRI) within 270 minutes of symptoms onset or with perfusion CT or MRI criteria for an extended treatment window or wake-up strokes.
- Intravenous thrombolysis with tenecteplase
Who cannot join
- Contra-indication to intravenous thrombolysis
- Intravenous thrombolysis with alteplase
- Venous ischemic stroke
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Saint-Antoine
Paris
Gaspard Gerschenfeld, MD, PhD, 1 42 16 24 75 ext. +33, gaspard.gerschenfeld@aphp.fr
Marion Yger, MD, 1 42 16 06 51 ext. +33, marion.yger@aphp.fr
About this study
The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase
Read the detailed description
Acute ischemic stroke management has considerably evolved over the last 20 years with the development of reperfusion treatments: intravenous thrombolysis (IVT) with alteplase, which is effective for AIS within 4.5 hours from symptoms onset and up to 9 hours in some cases; and mechanical thrombectomy (MT), in AIS with large vessel occlusion (LVO) within 24 hours from symptoms onset, either after IVT (bridging therapy) or alone in case of IVT contra-indication.
Alteplase is a recombinant form of tissue plasminogen activator (rtPA) that, when bound to fibrin, will activate plasminogen and lead to fibrinolysis and clot dissolution. It is administered at a dose of 0.9 mg/kg (maximum 90 mg) with an intravenous bolus (10% of the dose) followed by a one-hour infusion. Tenecteplase is a genetically modified form of alteplase with greater fibrin specificity and a longer half-life, which allows a simpler one bolus administration at a dose of 0.25 mg/kg (maximum 25 mg).
In the Tenecteplase versus Alteplase before Endovascular Therapy for Ischemic Stroke (EXTEND-IA TNK) randomized clinical trial, which compared tenecteplase and alteplase in bridging therapy for AIS with LVO, tenecteplase achieved a better recanalization rate on arteriography before MT and a better functional outcome at 3 months. Following this trial, tenecteplase was added in stroke guidelines as an alternative to alteplase for IVT in bridging therapy. More recently, the Alteplase compared to Tenecteplase (ACT) trial has shown, in patients with LVO and non-LVO AIS, that tenecteplase is non-inferior to alteplase in terms of functional outcome. It is likely that in the near future tenecteplase will be added as an alternative to alteplase for AIS without LVO. However, while some "real-life" studies have been published on tenecteplase use for AIS with LVO, data on the general use of tenecteplase are still scarce.
The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase. The main aim of this registry is to provide routine clinical care data on the use of tenecteplase for IVT for both AIS with and without LVO, in order to further characterize the safety and efficacy of tenecteplase for AIS. Additionally, we aim to use this registry which combines clinical and radiological data to explore other aspects related to AIS management in this cohort.
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Ischemic stroke, Thrombolytic therapy, Tenecteplase, Thrombectomy, Cerebrovascular Disorders, Brain diseases, Central Nervous Diseases, Nervous system Diseases, Vascular Diseases, Cardiovascular Diseases
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase | All consecutive patients with an arterial acute ischemic stroke treated with intravenous thrombolysis with tenecteplase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Modified Rankin score (mRS), score ranging from 0 (no symptom) to 6 (death).
Measured: Day 90
Secondary outcomes (9)
Efficacy on functional independence (mRS ≤ 2)
Rate of functional independence defined as a modified Rankin score 0-2
Measured: Day 90
Mortality rate
Rate of all-cause mortality
Measured: Day 90
Early neurological outcome
National Institutes of Health Stroke Scale (NIHSS) score after 24 hours, ranging from 0 (no symptom) to 42 (death)
Measured: Day 1
Incidence of haemorrhagic transformation
Incidence of intracerebral haemorrhage on MRI or CT after 24 hours (±12 hours) according to the ECASS II classification.
Measured: Day 1
Incidence of symptomatic intracerebral haemorrhage (sICH)
Incidence of sICH according to the SITS-MOST definition.
Measured: Day 1
Pre-thrombectomy recanalization rate
Rate of complete or near complete recanalization, defined as an extended Thrombolysis in Cerebral Infarction (mTICI) 2b50/2b66/2c/3 before thrombectomy
Measured: Day 1
Final recanalization rate
Rate of complete or near complete recanalization after
Measured: Day 1
Thrombolysis complication rate
Rate of complications linked to intravenous thrombolysis with tenecteplase
Measured: Day 1
Thrombectomy complication rate
Rate of patients with secondary decompressive craniectomy
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Alamowitch, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisGaspard Gerschenfeld, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534360
- Sponsor's protocol ID
- APHP220465
- Acronym
- TETRIS
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gerschenfeld G, Lapergue B, Seners P, Piotin M, Chausson N, Scarcia L, Arquizan C, Costalat V, Olindo S, Marnat G, Guillon B, Bourcier R, Yger M, Allard J, Richard S, Gory B, Pico F, Macian Montoro F, Mounayer C, Ben Hassen W, Venditti L, Caroff J, Clarencon F, Consoli A, Turc G, Alamowitch S; ETIS and TETRIS investigators. IV Tenecteplase Before Thrombectomy Compared With Thrombectomy Alone in Patients With Stroke Due to a Large Vessel Occlusion. Neurology. 2026 Mar 24;106(6):e214702. doi: 10.1212/WNL.0000000000214702. Epub 2026 Feb 12.
PubMed 41678809Gerschenfeld G, Turc G, Obadia M, Chausson N, Consoli A, Olindo S, Caroff J, Marnat G, Blanc R, Ben Hassen W, Seners P, Guillon B, Wiener E, Bourcier R, Yger M, Cho TH, Checkouri T, Gory B, Smadja D, Sibon I, Richard S, Piotin M, Eker OF, Pico F, Lapergue B, Alamowitch S; for ETIS and TETRIS study groups. Functional Outcome and Hemorrhage Rates After Bridging Therapy With Tenecteplase or Alteplase in Patients With Large Ischemic Core. Neurology. 2024 Jul 9;103(1):e209398. doi: 10.1212/WNL.0000000000209398. Epub 2024 Jun 11.
PubMed 38862134
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenecteplase Treatment in Ischemic Stroke Registry
- ClinicalTrials.gov ID
- NCT05534360
- Acronym / sponsor ID
- TETRIS / APHP220465
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Ischemic stroke, Thrombolytic therapy, Tenecteplase, Thrombectomy, Cerebrovascular Disorders, Brain diseases, Central Nervous Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Sep 2022 (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.
The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase
Detailed description
Acute ischemic stroke management has considerably evolved over the last 20 years with the development of reperfusion treatments: intravenous thrombolysis (IVT) with alteplase, which is effective for AIS within 4.5 hours from symptoms onset and up to 9 hours in some cases; and mechanical thrombectomy (MT), in AIS with large vessel occlusion (LVO) within 24 hours from symptoms onset, either after IVT (bridging therapy) or alone in case of IVT contra-indication.
Alteplase is a recombinant form of tissue plasminogen activator (rtPA) that, when bound to fibrin, will activate plasminogen and lead to fibrinolysis and clot dissolution. It is administered at a dose of 0.9 mg/kg (maximum 90 mg) with an intravenous bolus (10% of the dose) followed by a one-hour infusion. Tenecteplase is a genetically modified form of alteplase with greater fibrin specificity and a longer half-life, which allows a simpler one bolus administration at a dose of 0.25 mg/kg (maximum 25 mg).
In the Tenecteplase versus Alteplase before Endovascular Therapy for Ischemic Stroke (EXTEND-IA TNK) randomized clinical trial, which compared tenecteplase and alteplase in bridging therapy for AIS with LVO, tenecteplase achieved a better recanalization rate on arteriography before MT and a better functional outcome at 3 months. Following this trial, tenecteplase was added in stroke guidelines as an alternative to alteplase for IVT in bridging therapy. More recently, the Alteplase compared to Tenecteplase (ACT) trial has shown, in patients with LVO and non-LVO AIS, that tenecteplase is non-inferior to alteplase in terms of functional outcome. It is likely that in the near future tenecteplase will be added as an alternative to alteplase for AIS without LVO. However, while some "real-life" studies have been published on tenecteplase use for AIS with LVO, data on the general use of tenecteplase are still scarce.
The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase. The main aim of this registry is to provide routine clinical care data on the use of tenecteplase for IVT for both AIS with and without LVO, in order to further characterize the safety and efficacy of tenecteplase for AIS. Additionally, we aim to use this registry which combines clinical and radiological data to explore other aspects related to AIS management in this cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenecteplase | – | –All consecutive patients with an arterial acute ischemic stroke treated with intravenous thrombolysis with tenecteplase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients with an acute arterial ischemic stroke who received intravenous thrombolysis with tenecteplase in the participating centers.
Key inclusion criteria (3 listed)
- Age 18 and older
- Confirmed acute arterial ischemic stroke on brain imaging (CT or MRI) within 270 minutes of symptoms onset or with perfusion CT or MRI criteria for an extended treatment window or wake-up strokes.
- Intravenous thrombolysis with tenecteplase
Key exclusion criteria (3 listed)
- Contra-indication to intravenous thrombolysis
- Intravenous thrombolysis with alteplase
- Venous ischemic stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional outcome
Time frame: Day 90
Modified Rankin score (mRS), score ranging from 0 (no symptom) to 6 (death).
9 secondary outcomes
Efficacy on functional independence (mRS ≤ 2)
Time frame: Day 90
Mortality rate
Time frame: Day 90
Early neurological outcome
Time frame: Day 1
Incidence of haemorrhagic transformation
Time frame: Day 1
Incidence of symptomatic intracerebral haemorrhage (sICH)
Time frame: Day 1
Pre-thrombectomy recanalization rate
Time frame: Day 1
Final recanalization rate
Time frame: Day 1
Thrombolysis complication rate
Time frame: Day 1
Thrombectomy complication rate
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Derived from this study: PubMed 41678809Gerschenfeld G, Lapergue B, Seners P, Piotin M, Chausson N, Scarcia L, Arquizan C, Costalat V, Olindo S, Marnat G, Guillon B, Bourcier R, Yger M, Allard J, Richard S, Gory B, Pico F, Macian Montoro F, Mounayer C, Ben Hassen W, Venditti L, Caroff J, Clarencon F, Consoli A, Turc G, Alamowitch S; ETIS and TETRIS investigators. IV Tenecteplase Before Thrombectomy Compared With Thrombectomy Alone in Patients With Stroke Due to a Large Vessel Occlusion. Neurology. 2026 Mar 24;106(6):e214702. doi: 10.1212/WNL.0000000000214702. Epub 2026 Feb 12.
- Derived from this study: PubMed 38862134Gerschenfeld G, Turc G, Obadia M, Chausson N, Consoli A, Olindo S, Caroff J, Marnat G, Blanc R, Ben Hassen W, Seners P, Guillon B, Wiener E, Bourcier R, Yger M, Cho TH, Checkouri T, Gory B, Smadja D, Sibon I, Richard S, Piotin M, Eker OF, Pico F, Lapergue B, Alamowitch S; for ETIS and TETRIS study groups. Functional Outcome and Hemorrhage Rates After Bridging Therapy With Tenecteplase or Alteplase in Patients With Large Ischemic Core. Neurology. 2024 Jul 9;103(1):e209398. doi: 10.1212/WNL.0000000000209398. Epub 2024 Jun 11.
- Institutional study linkLink provided by the sponsor.
- 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.
Sonia Alamowitch, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Gaspard Gerschenfeld, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 9 Sep 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonia Alamowitch, MD (1 71 97 06 51 ext. +33, sonia.alamowitch@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: Day 90). 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 NCT05534360, which also lists 2 linked publications.
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 9 Sep 2022.