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Acute Ischemic StrokePhase 3NCT05626972

Tenecteplase Compared to Alteplase for Patients With Large Vesel Oclusion Suspicion Before Thrombectomy

A Phase 3 study testing Tenecteplase in people with Acute Ischemic Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: The TNKCAT trial represents an innovative approach to optimize timely reperfusion in the Mothership and Drip-and-Ship scenarios. The logistic advantage of a single bolus infusion of TNK (compared to 1-h infusion of tPA) would markedly reduce the needle-to-groin and Door-in- door-out time. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Tenecteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteSpain
Study dates
27 May 2022to May 2024
Phase
Phase 3
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

Who may be able to join

  • Patients eligible to undergo intravenous thrombolysis (tPA or TNK) within 4.5 hours after the onset of ischemic stroke.
  • Suspicion of Cerebral vascular occlusion on brain imaging.
  • Age >18 years old
  • Men and women (women with child-bearing potential are excluded, unless pregnancy test negative/ confirmed menstrual period/ postmenopausal or hysterectomy).
  • A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
  • Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative), or Differed Inform Consent (DIC) to avoid any delay in the initiation of iv thrombolysis. The DIC will be sign by the patient or next of kin at any time after the tPA or TNK treatment is started.

Who cannot join

  • Patients with severe preexisting disability, defined as a modified Rankin scale score >3.
  • Glasgow Coma Scale score ≤ 7.
  • Known hemorrhagic diathesis, coagulation factor deficiency, or antivitamin K oral anticoagulant therapy with INR >3.0. Subjects on factor Xa inhibitors (e.g. apixaban) or direct thrombin inhibitors are eligible for participation.
  • Severe, sustained and uncontrollable hypertension (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg).
  • Serious, advanced, or terminal illness with anticipated life expectancy of less than 3 months.
  • Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).
Show all 15Show fewer
  • Patient participating in a randomized study, involving an investigational drug or device that would impact this study.
  • Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.
  • Imaging exclusion criteria:
  • Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
  • Cerebral vasculitis.
  • CT or MRI evidence of hemorrhage
  • Significant mass effect with midline shift.
  • Evidence of intracranial tumor.
  • Subjects with known occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).

Trial locations and contacts

1 site in 1 country.

Carlos Molina, Dr contact

(+34) 93 489 30 00 ext. 4996

cmolina@vhebron.net

Spain1 site, 1 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Carlos Molina, Dr., (+34) 93 489 30 00 ext. 4996, cmolina@vhebron.net

    Recruiting

Other trials in Spain

About this study

Official title: A Multi-center, Randomized, Open-label Blinded Endpoint (PROBE), Phase III Study, for the Comparation of Tenecteplase (TNK) Versus Alteplase, With a 1:1 Allocation, Before Thrombectomy in Patients With Acute Ischemic Stroke and Large Vessel Occlusion Suspicion in Catalonia (TNK-CAT)

Background: The TNKCAT trial represents an innovative approach to optimize timely reperfusion in the Mothership and Drip-and-Ship scenarios. The logistic advantage of a single bolus infusion of TNK (compared to 1-h infusion of tPA) would markedly reduce the needle-to-groin and Door-in- door-out time. The implementation of a quality improvement package (QIP) in the TNKCAT trial would directly improve the quality and efficiency of the Health Care System. In addition, an improvement of transfer models would reduce the cost of unnecessary transfers, together with the fact that TNK is up to 50% less expensive than tPA, makes the TNKCAT in firm line with the sustainability strategy of the National Health Care system.

Outcomes: The aim of the present study is to determine the safety and efficacy of TNK (0.25mh/kg) compared to tPA (0.9 mg/kg) in patients with Large Vessel Occlusion (LVO) suspicion, candidates for thrombectomy, in both Mothership and Drip-and-Ship scenarios.

Read more

Study Duration: 2 years. Patients will participate in the trial for 3 months.

Study design: Multicentre, prospective, randomized open-label blinded endpoint (PROBE) phase III study in acute stroke patients with LVO suspicion within 4.5 hours of stroke onset, candidates for EVT. Patients will be randomized 1:1 to standard dose tPA (0.9 mg/kg) or TNK (0.25mg/kg) before EVT.

Clinical, imaging and outcome data will be collected at baseline, 24-36 hours, day 3, day 5 and day 90.

Estimated enrollment: 500 patients

Being tested
Tenecteplase
Keywords
acute ischemic stroke, large vessel occlusion
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TenecteplaseDrug

    Patients will be randomized 1:1 to standard dose tPA (0.9 mg/kg) or TNK (0.25mg/kg) before endovascular therapy (EVT)

Study groups in NCT05626972
Study groupRoleWhat they receive
Tenecteplase (TNK)Active comparatorDrug: Alteplase (tPA) Dose: 0.9 mg/kg Route: Intravenous (IV) infusion
Receives: Drug: Tenecteplase
Alteplase (tPA)Active comparatorDrug: Tenecteplase (TNK) Dose: 0.25 mg/kg Route: Intravenous (IV) bolus injection
Receives: Drug: Tenecteplase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin scale score at 3 months

    Shift analysis of the modified Rankin scale score at 3 months

    Measured: 3 months

  2. Mortality rate

    Mortality at 3 months

    Measured: 3 months

  3. Symptomatic intracerebral haemorrhage (ICH) and neurological deterioration

    Symptomatic ICH defined as intracerebral haemorrhage (PH2) within 36 hours of treatment, combined with neurological deterioration leading to an increase of ≥ 4 points on the National institute of Health Stroke Scale (NIHSS) from baseline, or the lowest NIHSS value between baseline and 24 hours.

    Measured: 24 -36hours

Secondary outcomes (9)

  1. Rates of mRS 0-1 at 3 months

    Modified Rankin scale score (0-1) rates

    Measured: 3 months

  2. Rates of mRS 0-2 at 3 months

    Modified Rankin scale score (0-2) rates

    Measured: 3 months

  3. Rates of pre-interventional recanalization

    Recanalization rate

    Measured: during the procedure

  4. Dramatic clinical recovery before endovascular treatment (EVT)

    Dramatic clinical recovery before EVT (Improvement in > 8 points in the NIHSS score or NIHSS score < 2 before groin puncture)

    Measured: before the procedure

  5. First pass TICI 3, final TICI 2b-3

    Rates of first pass TICI 3, final TICI 2b-3

    Measured: immediately after the procedure

  6. Distal embolization during EVT

    Rates of distal embolization during EVT

    Measured: during the procedure

  7. Needle-to-groin times and DIDO times

    Differences in needle-to-groin times in Mothership patients and in DIDO times in Drip-and-Ship patients.

    Measured: immediately after the procedure

  8. Time metrics between TNKCAT and non-TNKCAT centers

    Differences in time metrics between TNKCAT and non-TNKCAT centers

    Measured: at the end of the study

  9. Final infarct volume on follow up CT

    Differences in final infarct volume on follow up CT

    Measured: 24-36 hours follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2022
  2. Study start27 May 2022
  3. Primary completionMay 2023 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05626972
Sponsor's protocol ID
2020-001599-13
Status last verified
Nov 2022
First submitted
4 Nov 2022
Last updated
25 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenecteplase in people with Acute Ischemic Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

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 15 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 25 Nov 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Carlos Molina, Dr ((+34) 93 489 30 00 ext. 4996, cmolina@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin scale score at 3 months (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT05626972.

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 Nov 2022.

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