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

Completed

• Conditions: Paramedian Pontine Infarction (IPP); Acute Anterior Choroidal Infarction (ACI)
• Interventions: Procedure: IVT with tenecteplase or alteplase

• Registration Number: NCT05733507
• Lead Sponsor: Centre Hospitalier Sud Francilien

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.

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Study Start: 2023-04-03
• Primary Completion: 2023-09-13
• Study Completion: 2023-09-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intravenous thrombolysis (IVT)	IVT with tenecteplase or alteplase	group of patients treated with IVT alone

Primary Outcome Measures

Name	Time	Method
Volume of the ischemic lesion	at 24 hours	Evolution of the volume of the ischemic lesion in diffusion-weighted imaging between initial MRI and post-therapy MRI

Secondary Outcome Measures

Name	Time	Method
Systemic bleedings	at 24 hours	Rate of significant systemic bleeding (i.e., requiring specific treatment).
NIHSS	at day 7	NIHSS (from 0=favorable to 42=unfavorable)
Modified Rankin Scale (mRS)	at 3 months	Proportion of the patients with mRS 0-2
Cerebral hemorrhages	at 24 hours	Rates of cerebral hemorrhages defined according to the Heidelberg Bleeding Classification
Secondary neurological deterioration	at 72 hours	Rate of secondary neurological deterioration (fluctuations or neurological progression defined as an increase of at least 1 point in NIHSS).

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France