NCT07026318Recruiting
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 716 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- 15 Aug 2025
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Stroke
- NCT number
- NCT07026318
What you commit to
- Study type: Interventional
- Planned participants: 716
- From 15 Aug 2025 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT
- Tirofiban or other GP IIb/IIIa inhibitor use before randomization or other GP IIb/IIIa inhibitor used post treatment
Other illness
- Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days
- Pre-existing neurological/psychiatric conditions that may confound assessment
- Any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent MI, cardiomyopathy with EF \<30%, etc.)
Lab values
- Bleeding diathesis including coagulopathy (platelets \<100×10⁹/L, aPTT \>50s, or INR \>2.0), DOAC use within 48 hours, or history of HIT
- Severe renal insufficiency (GFR \<30mL/min or Scr \>220μmol/L \[2.5mg/dL\])
Other
- Pregnancy or lactation at admission
- Contraindications to radiographic contrast agents, nickel, titanium or their alloys
- Life expectancy \<6 months
- Arterial tortuosity or anomalies preventing device delivery
- Unlikely to complete 90-day follow-up
Who the study is looking for
- Age ≥18 years
- Pre-stroke modified Rankin Scale (mRS) score of 0-1
- Acute ischemic stroke symptoms present within 24 hours of last known well time
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6
- Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 Posterior circulation: pc-ASPECTS ≥6
- Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery
- Clinical care team plans to perform endovascular thrombectomy (EVT)
- Subject or legally authorized representative can provide informed consent
- Residual stenosis ≥50% without planned angioplasty/stenting
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.