Early Recanalization After Intravenous Thrombolysis With Tenecteplase Versus Alteplase in Distal Vessel Occlusion Strokes

NCT05635786 | Completed

• 1 other identifier: 2022/0037
• Study Type: observational
• Target: 319
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this monocentric retrospective study is to compare, in patients with acute distal vessel occlusion stroke, the early rates of successful recanalization in patients treated with Alteplase (ALT) versus Tenecteplase (TNK), based on a retrospective analysis of magnetic resonance imaging (MRI) performed early after IVT.

Conditions

Acute Distal Vessel Occlusion Stroke

Keywords

Acute; occlusion; recanalization; tenecteplase; alteplase; thrombolysis; ischemic; stroke-distal

Outcome Measures

Primary Outcomes (1)

• Early successful recanalization rate

  Early successful recanalization rate defined by an Arterial Occlusive Lesion (AOL) scale grade 2 or 3 on MRI-2 performed between 1 and 2 hours after IVT.

  Between 1 and 2 hours after IVT

Secondary Outcomes (5)

• Early complete recanalization rate

  Between 1 and 2 hours after IVT

• Thrombus length change

  Between 1 and 2 hours after IVT

• Evolution of cerebral infarct volume

  Between 1 and 2 hours after IVT

• Rates of early post-thrombolysis intracerebral hemorrhage

  Between 1 and 2 hours after IVT

• Very early clinical modification

  Between 1 and 2 hours after IVT

Study Arms (2)

Alteplase (ALT)

Patients with distal vessel occlusion stroke treated with alteplase (from March 2016 to February 2018)

Drug: Alteplase (0.9mg/kg)

Tenecteplase (TNK)

Patients with distal vessel occlusion stroke treated with tenecteplase (from March 2018 to February 2020)

Drug: Tenecteplase (0.25mg/kg)

Interventions

Alteplase (0.9mg/kg) DRUG

Intravenous thrombolysis with Alteplase (0.9 mg/kg, maximum 90 mg) with 10% of the dose given as a bolus followed by an infusion lasting 60 minutes.

Alteplase (ALT)

Tenecteplase (0.25mg/kg) DRUG

Intravenous thrombolysis with Tenecteplase (0.25mg/kg, maximum 25 mg) with 100% of the dose given as a bolus.

Tenecteplase (TNK)

Eligibility Criteria

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

Study Population

This is a monocentric retrospective study (Sud-Francilien Hospital (SFH), Corbeil-Essonnes, France) based on a stroke registry prospectively gathered. From March 2016 to February 2020, consecutive patients with acute ischemic stroke (AIS) assessed on brain MRI and treated with IVT alone who fulfilled the following criteria will be included: 18 years or older; evidence of an AIS on acute MRI (MRI-1) associated with a distal vessel occlusion as defined below; IVT within 4h30 of symptoms onset; availability of a post-IVT MRI within 1-2 hours (MRI-2); good quality of MRI sets including SWAN images.

You may qualify if:

• Age≥ 18 years.
• Acute ischemic stroke (visible on DWI, but not visible on FLAIR) on initial MRI associated with distal arterial occlusion as defined below:
• A distal occlusion of the M2 segment of the middle cerebral artery (MCA)
• Occlusion (regardless of location) of a non-dominant M2 branch of the MCA
• Occlusion of the M3 segment of the MCA.
• Occlusion of the A2 or A3 segment of the anterior cerebral artery (ACA)
• Occlusion of the P2 or P3 branch of the posterior cerebral artery (PCA).
• A proximal M2-MCA or proximal P1-PCA occlusion may also be included if not eligible for mechanical thrombectomy, especially if the initial NIHSS score is low (\<5).
• Distal arterial occlusion is identified by MRI either on the TOF (Time of Flight)-ARM sequence and/or on the presence of a thrombus (Susceptibility Vessel sign, SVS) on the SWAN sequence,
• IVT by ALT or TNK within 4H30 after onset of symptoms,
• Early brain MRI performed 1 to 2 hours after IVT (MRI n°2),
• Good quality MRI (absence of motion artifact interfering with interpretation) with availability of DWI, FLAIR, TOF-MRA and SWAN sequences.

You may not qualify if:

• \- Patients informed of the study who objected to the collection of their data.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106, France

Location

MeSH Terms

Conditions

Bites and Stings; Ischemia

Interventions

Tissue Plasminogen Activator; Tenecteplase

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 2, 2022
• Study Start: January 2, 2023
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)