Clinical trial NCT05733507: Tirofiban Plus Intravenous Thrombolysis in Acute Anterior Choroidal Infarction or Paramedian Pontine Infarction
Official title: Efficacy of Simultaneous Infusion of Tirofiban With Intravenous Thrombolysis in Patients With Acute Anterior Choroidal Infarction or Paramedian Pontine Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Anterior Choroidal Infarction (ACI)
Paramedian Pontine Infarction (IPP)
Keywords: anterior choroidal infarction
paramedian pontine infarction
intravenous thrombolysis
tirofiban
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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:

* Patients with contraindications 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 leptomeningeal hemosiderosis suggestive of amyloid angiopathy.
* Patients with pre-stroke mRS ≥ 3.
* Patients informed of the research and objecting to the collection of their data.

Primary outcomes:
measure: Volume of the ischemic lesion
timeFrame: at 24 hours
Secondary outcomes:
measure: NIHSS
timeFrame: at day 7
measure: Modified Rankin Scale (mRS)
timeFrame: at 3 months
measure: Secondary neurological deterioration
timeFrame: at 72 hours
measure: Cerebral hemorrhages
timeFrame: at 24 hours
measure: Systemic bleedings
timeFrame: at 24 hours
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References: