Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorXinqiao Hospital of Chongqing

About this trial

In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or alteplase before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus alteplase for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older.

Presenting with acute ischemic stroke symptom.

(1) within 4.5 hours

(2) 4.5-9.0 hours, image inclusion criteria for the EXTEND trial must be met

Disqualifiers

CT or MR evidence of hemorrhage (the presence of micro-bleeds is allowed);

Contraindications of IV rt-PA or tirofiban;

Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;

Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirofiban

    Drug

    Intravenous tirofiban before endovascular thrombectomy.

  • Alteplase

    Drug

    Intravenous alteplase before endovascular thrombectomy.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: TirofibanExperimental treatment 1 intervention
Group B: AlteplaseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional independence

modified Rankin scale score of 0 to 2. (The modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

Time frame
90 days post-endovascular treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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Xinqiao Hospital of Chongqing

Lead sponsor

Zhejiang University

Collaborator