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

NCT05626972 | Unknown Phase 3

• 1 other identifier: 2020-001599-13
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; large vessel occlusion

Outcome Measures

Primary Outcomes (3)

• Modified Rankin scale score at 3 months

  Shift analysis of the modified Rankin scale score at 3 months

  3 months

• Mortality rate

  Mortality at 3 months

  3 months

• 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.

  24 -36hours

Secondary Outcomes (9)

• Rates of mRS 0-1 at 3 months

  3 months

• Rates of mRS 0-2 at 3 months

  3 months

• Rates of pre-interventional recanalization

  during the procedure

• Dramatic clinical recovery before endovascular treatment (EVT)

  before the procedure

• First pass TICI 3, final TICI 2b-3

  immediately after the procedure

Study Arms (2)

Tenecteplase (TNK)

ACTIVE COMPARATOR

Drug: Alteplase (tPA) Dose: 0.9 mg/kg Route: Intravenous (IV) infusion

Drug: Tenecteplase

Alteplase (tPA)

ACTIVE COMPARATOR

Drug: Tenecteplase (TNK) Dose: 0.25 mg/kg Route: Intravenous (IV) bolus injection

Drug: Tenecteplase

Interventions

Tenecteplase DRUG

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

Alteplase (tPA); Tenecteplase (TNK)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• 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).

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Carlos Molina, Dr

CONTACT

(+34) 93 489 30 00; cmolina@vhebron.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcome at day 90 will be obtained by centralized telephone call of the mRS in a blinded manner by certified personnel of the Catalan Stroke Program.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 25, 2022
• Study Start: May 27, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)