Skip to content

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

Efficacy of Simultaneous Infusion of Tirofiban With Intravenous Thrombolysis in Patients With Acute Anterior Choroidal Infarction or Paramedian Pontine Infarction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05733507
Acronym
TITACIPPI
Enrollment
48
Registered
2023-02-17
Start date
2023-04-03
Completion date
2023-09-13
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

anterior choroidal infarction, paramedian pontine infarction, intravenous thrombolysis, tirofiban

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.

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.

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Volume of the ischemic lesionat 24 hoursEvolution of the volume of the ischemic lesion in diffusion-weighted imaging between initial MRI and post-therapy MRI

Secondary

MeasureTime frameDescription
NIHSSat day 7NIHSS (from 0=favorable to 42=unfavorable)
Modified Rankin Scale (mRS)at 3 monthsProportion of the patients with mRS 0-2
Secondary neurological deteriorationat 72 hoursRate of secondary neurological deterioration (fluctuations or neurological progression defined as an increase of at least 1 point in NIHSS).
Cerebral hemorrhagesat 24 hoursRates of cerebral hemorrhages defined according to the Heidelberg Bleeding Classification
Systemic bleedingsat 24 hoursRate of significant systemic bleeding (i.e., requiring specific treatment).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026