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Completed

NCT Number: NCT05733507

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVT with tenecteplase or alteplase

Procedure

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.

Intervention Name : Tirofiban and IVT with tenecteplase or alteplase

Procedure

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

Primary outcomes

  1. Volume of the ischemic lesion

    Time frame: at 24 hours

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

Secondary outcomes

  1. NIHSS

    Time frame: at day 7

    NIHSS (from 0=favorable to 42=unfavorable)

  2. Modified Rankin Scale (mRS)

    Time frame: at 3 months

    Proportion of the patients with mRS 0-2

  3. Secondary neurological deterioration

    Time frame: at 72 hours

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

  4. Cerebral hemorrhages

    Time frame: at 24 hours

    Rates of cerebral hemorrhages defined according to the Heidelberg Bleeding Classification

  5. Systemic bleedings

    Time frame: at 24 hours

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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

Acronym: TITACIPPI

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.