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Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke

NCT07290751 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 976

Last updated 2025-12-23

No results posted yet for this study

Summary

This multicenter, prospective, double-blind, placebo-controlled, randomized trial (ANGEL-DRUG2) aims to evaluate the efficacy and safety of intravenous tirofiban following intravenous thrombolysis in patients with acute ischemic stroke who show insufficient neurological improvement after initial treatment. Eligible patients (≥18 years, baseline NIHSS ≥4, within 4.5 hours from last known well) will be randomized 1:1 to receive either tirofiban or placebo infusion for 24 hours, followed by standard oral antiplatelet therapy. The primary endpoint is the proportion of patients achieving functional independence (mRS 0-2) at 90 days. Secondary outcomes include changes in NIHSS score, vessel recanalization, infarct volume, distribution of mRS scores, recurrent stroke, and health-related quality of life. Safety outcomes focus on symptomatic intracranial hemorrhage and all-cause mortality. Approximately 976 patients will be enrolled across 30 sites in China.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Tirofiban

After intravenous thrombolysis, if neurological improvement is insufficient (NIHSS score decrease \<2 within 1 hour or NIHSS increase ≥1), tirofiban infusion is initiated within 1 hour. The regimen consists of 0.4 μg/kg/min for 30 minutes, followed by 0.1 μg/kg/min for 23.5 hours (total 24 hours). At the 20th hour of infusion, oral antiplatelet therapy (aspirin 100 mg once daily and/or clopidogrel 75 mg once daily) is initiated, overlapping with tirofiban for 4 hours (bridge therapy). At 24 hours, tirofiban infusion is completed, and patients continue oral antiplatelet therapy per protocol.

OTHER

Placebo (0.9% normal saline)

Matched normal saline infusion using the same dosing schedule and pump rates as the tirofiban arm (0.4 μg/kg/min for 30 minutes, then 0.1 μg/kg/min for 23.5 hours; total 24 hours). At the 20th hour of infusion, oral antiplatelet therapy (aspirin 100 mg once daily and/or clopidogrel 75 mg once daily) is initiated, overlapping with placebo infusion for 4 hours (bridge therapy). At 24 hours, placebo infusion is completed, and patients continue oral antiplatelet therapy per protocol.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2026-10-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290751 on ClinicalTrials.gov