NCT05534360

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Sep 2022Mar 2028

Study Start

First participant enrolled

September 1, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

5.5 years

First QC Date

September 6, 2022

Last Update Submit

September 6, 2022

Conditions

Stroke, Acute

Keywords

StrokeIschemic strokeThrombolytic therapyTenecteplaseThrombectomyCerebrovascular DisordersBrain diseasesCentral Nervous DiseasesNervous system DiseasesVascular DiseasesCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

    Modified Rankin score (mRS), score ranging from 0 (no symptom) to 6 (death).

    Day 90

Secondary Outcomes (9)

  • Efficacy on functional independence (mRS ≤ 2)

    Day 90

  • Mortality rate

    Day 90

  • Early neurological outcome

    Day 1

  • Incidence of haemorrhagic transformation

    Day 1

  • Incidence of symptomatic intracerebral haemorrhage (sICH)

    Day 1

  • +4 more secondary outcomes

Study Arms (1)

Tenecteplase

All consecutive patients with an arterial acute ischemic stroke treated with intravenous thrombolysis with tenecteplase.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive adult patients with an acute arterial ischemic stroke who received intravenous thrombolysis with tenecteplase in the participating centers.

You may qualify if:

  • 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

You may not qualify if:

  • Contra-indication to intravenous thrombolysis
  • Intravenous thrombolysis with alteplase
  • Venous ischemic stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Saint-Antoine

Paris, France

Location

Related Publications (1)

  • Gerschenfeld 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.

    PMID: 38862134DERIVED

Related Links

MeSH Terms

Conditions

StrokeIschemic StrokeCerebrovascular DisordersBrain DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases

Study Officials

  • Sonia Alamowitch, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Gaspard Gerschenfeld, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Alamowitch, MD

CONTACT

1 71 97 06 51sonia.alamowitch@aphp.fr

Gaspard Gerschenfeld, MD, PhD

CONTACT

1 42 16 24 75gaspard.gerschenfeld@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 9, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

September 9, 2022

Record last verified: 2022-09

Locations

FR(1)