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Intra-Arterial Tirofiban After Complete Recanalization for Acute Intracranial Large-Vessel Occlusion

ConditionsAcute Ischemic StrokeLarge-vessel OcclusionEndovascular Treatment
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong Provincial Hospital

About this trial

The goal of this clinical trial is to learn if immediate intra-arterial tirofiban after complete recanalization can improve recovery in adults with acute ischemic stroke caused by anterior circulation large-vessel occlusion. It will also learn about the safety of this treatment. The main questions it aims to answer are:

Does immediate intra-arterial tirofiban after complete recanalization increase the number of participants with good functional outcome at 90 days? Does this treatment increase the risk of symptomatic intracranial hemorrhage or other important bleeding events?

Researchers will compare immediate intra-arterial tirofiban with no intra-arterial tirofiban after complete recanalization to see if tirofiban improves recovery and is safe.

Participants will:

Be enrolled after mechanical thrombectomy achieves complete recanalization Be randomly assigned to receive intra-arterial tirofiban or no intra-arterial tirofiban Receive follow-up assessments during hospitalization and at 90 days

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirofiban

    Drug

    Immediate intra-arterial tirofiban (0.5 mg) infusion administered after achieving eTICI 2c-3 complete recanalization in patients with acute ischemic stroke due to large-vessel occlusion. The infusion is delivered over 10 minutes (1 mL/min).

Treatment groups

344 Participants
are divided into 2 treatment groups
Group A: Intra-arterial Tirofiban TreatmentExperimental treatment 1 intervention
Group B: No Intra-arterial Tirofiban TreatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of Participants with Modified Rankin Scale (mRS) Score 0-1 at 90±7 Days

The primary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90±7 days, indicating functional independence after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion

Time frame
90±7 Days

Secondary outcomes

1

Proportion of Participants with Modified Rankin Scale (mRS) 0-2 at 90±7 Days

The secondary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90±7 days, indicating mild disability after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion.

Time frame
90±7 days
2

Proportion of Participants with mRS 0-3 at 90±7 Days

This secondary outcome measures the proportion of participants with a modified Rankin Scale (mRS) score of 0-3 at 90±7 days, indicating moderate disability

Time frame
90±7 Days
3

Symptomatic Intracranial Hemorrhage (sICH) within 48 Hours

This secondary outcome evaluates the incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours after treatment.

Time frame
48 hours
4

Any Intracranial Hemorrhage (ICH) within 48 Hours

This outcome measures the occurrence of any intracranial hemorrhage (ICH) within 48 hours following the intervention

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: