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

Sponsor

Centre Hospitalier Sud Francilien (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05733507

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Anterior Choroidal Infarction (ACI) Paramedian Pontine Infarction (IPP)	Procedure: IVT with tenecteplase or alteplase Procedure: Intervention Name : Tirofiban and IVT with tenecteplase or alteplase

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Intravenous thrombolysis (IVT) group of patients treated with IVT alone	Procedure: IVT 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.
Tirofiban + IVT groups of patients treated with simultaneous infusion of tirofiban and IVT	Procedure: Intervention 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.

Arm

Intervention/Treatment

Intravenous thrombolysis (IVT)

group of patients treated with IVT alone

Procedure: IVT 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.

Tirofiban + IVT

groups of patients treated with simultaneous infusion of tirofiban and IVT

Procedure: Intervention 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.

Outcome Measures

Primary Outcome Measures

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

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
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).
Cerebral hemorrhages [at 24 hours]
Rates of cerebral hemorrhages defined according to the Heidelberg Bleeding Classification
Systemic bleedings [at 24 hours]
Rate of significant systemic bleeding (i.e., requiring specific treatment).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.