ClinicalTrials.gg
CompletedNCT05733507TITACIPPIUpdated Nov 7, 2023

Tirofiban Plus Intravenous Thrombolysis in Acute Anterior Choroidal Infarction or Paramedian Pontine Infarction

An observational study in Acute Anterior Choroidal Infarction (ACI) and Paramedian Pontine Infarction (IPP), sponsored by Centre Hospitalier Sud Francilien. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Centre Hospitalier Sud Francilien · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study summary

TITACIPPI (Tirofiban with Intravenous Thrombolysis in Acute Anterior Choroidal Infarction [ACI] and Paramedian Pontine Infarction [IPP]) study aimed to evaluate the efficacy and safety of simultaneous infusion of tirofiban with intravenous thrombolysis (IVT + tirofiban group) compared to IVT alone (IVT alone group) in patients with ACI or PPI. TITACIPPI study is a retrospective, single-center observational study conducted from March 01, 2014, to December 31, 2022.

Read the detailed description

ACI and PPI are frequently associated with clinical fluctuations, characterized by recurrent transient more or less regressive stereotyped episodes of focal motor deficits affecting the face, arm, and leg, and finally with a risk of lasting neurological worsening that can lead to definite residual neurological disability. These ischemic strokes (ACI and PPI) are not very sensitive to IVT, thus 26% to 48% will experience neurological aggravation despite the administration of this treatment. Studies in Asia have shown a possible clinical benefit of simultaneous infusion of tirofiban with IVT in patients with ischemic stroke of atheromatous or microatheromatous origin without additional bleeding risk. To date, no studies have tested the efficacy of simultaneous infusion of tirofiban and IVT in the well-defined subgroup of ACI and PPI and a non-Asian population.

02

Conditions studied

  • Acute Anterior Choroidal Infarction (ACI)
  • Paramedian Pontine Infarction (IPP)

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Keywords

  • anterior choroidal infarction
  • paramedian pontine infarction
  • intravenous thrombolysis
  • tirofiban
03

In context

Infarction

71 studies on the registry are indexed under Infarction; 15 are open to participants now.

This study's enrollment of 48 is below the median of 119 across 23 observational studies indexed under Infarction.

Browse Infarction studies →

Lead sponsor

Centre Hospitalier Sud Francilien is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study included all patients aged ≥ 18 years with ACI or PPI, negative on FLAIR of the MRI of pretreatment, who had received IVT alone or simultaneous infusion of tirofiban with IVT in the stroke unit of CHSF between March 1, 2014, and December 31, 2022.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged ≥ 18 years with ACI or PPI between March 01, 2014 and December 31, 2022.
  • Patients hospitalized in the stroke unit of Centre Hospitalier Sud Francilien in the acute phase of their ischemic stroke (FLAIR negative on the pre-treatment brain MRI allowing IVT).
  • Patients with NIHSS ≥ 2 on admission
  • Patients treated with IVT
  • For the experimental group: patients treated with tirofiban at 0.4 μg/kg/min with the start of infusion within 1 hour of IVT initiation.
  • Patients with post-treatment brain MRI within 24-36h.

Exclusion criteria

Exclusion Criteria:

  • Patients with to IVT (cardiac, thoracic or digestive surgery less than 14 days old, thrombocytopenia \< 100,000/mm3, etc.).
  • Absence of MRI as initial imaging.
  • Less than 24 hours of continuous infusion of tirofiban.
  • Patients at high risk of cerebral hemorrhage: severe microangiopathy (Fazekas Score 3), microbleeds > 5, or hemosiderosis suggestive of amyloid angiopathy.
  • Patients with pre-stroke mRS ≥ 3.
  • Patients informed of the research and objecting to the collection of their data.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
48 participants (actual)
Patient registry
No

Groups and cohorts

  • Intravenous thrombolysis (IVT)

    group of patients treated with IVT alone

    Procedure: IVT with tenecteplase or alteplase

  • Tirofiban + IVT

    groups of patients treated with simultaneous infusion of tirofiban and IVT

    Procedure: Intervention Name : Tirofiban and IVT with tenecteplase or alteplase

Interventions

  • ProcedureIVT with tenecteplase or alteplase

    Patients received intravenous tenecteplase 0.25mg/kg (maximum dose: 25mg), administered as a bolus over 5 to 10 seconds or intravenous alteplase 0.9 mg/kg (maximum dose: 90mg), 10% as bolus and the remainder as continuous perfusion over 1 hour.

  • ProcedureIntervention Name : Tirofiban and IVT with tenecteplase or alteplase

    IVT with tenecteplase or alteplase with continuous infusion of tirofiban 0.4µg/kg/min continued for 24 to 48 hours.

06

What researchers measure

Primary outcomes

  1. Volume of the ischemic lesion

    Evolution of the volume of the ischemic lesion in diffusion-weighted imaging between initial MRI and post-therapy MRI

    Time frame: at 24 hours

Secondary outcomes

  1. NIHSS

    NIHSS (from 0=favorable to 42=unfavorable)

    Time frame: at day 7

  2. Modified Rankin Scale (mRS)

    Proportion of the patients with mRS 0-2

    Time frame: at 3 months

  3. Secondary neurological deterioration

    Rate of secondary neurological deterioration (fluctuations or neurological progression defined as an increase of at least 1 point in NIHSS).

    Time frame: at 72 hours

  4. Cerebral hemorrhages

    Rates of cerebral hemorrhages defined according to the Heidelberg Bleeding Classification

    Time frame: at 24 hours

  5. Systemic bleedings

    Rate of significant systemic bleeding (i.e., requiring specific treatment).

    Time frame: at 24 hours

07

Study locations

1 site
  • Centre Hospitalier Sud Francilien
    Corbeil-Essonnes, 91106, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2023 to primary completion in Sep 2023, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2023
First posted
Feb 17, 2023
StartActual
Apr 3, 2023
Primary completionActual
Sep 13, 2023
CompletionActual
Sep 13, 2023
Last update
Nov 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05733507
Lead sponsor
Centre Hospitalier Sud Francilien
Responsible party
Sponsor
First posted
Feb 17, 2023
Start date
Apr 3, 2023
Primary completion
Sep 13, 2023
Completion
Sep 13, 2023
Last update
Nov 7, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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