NCT05728333 Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke
| NCT ID | NCT05728333 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Xinqiao Hospital of Chongqing |
| Condition | Stroke, Acute Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2023-11-28 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 800 participants in total. It began in 2023-11-28 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Aged 18 years or older. 2. Presenting with acute ischemic stroke symptom. 3. Time from onset to hospital arrival: * (1) within 4.5 hours * (2) 4.5-9.0 hours, image inclusion criteria for the EXTEND trial must be met * (3) \> 4.5 hours but within 24 hours, image inclusion criteria for the WAKE-UP trial must be met. 4. Eligible for intravenous thrombolysis. 5. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, vertebrobasilar artery confirmed by CTA, MRA, or DSA. 6. Informed consent obtained from patients or their legal representatives. Exclusion Criteria: 1. CT or MR evidence of hemorrhage (the presence of micro-bleeds is allowed); 2. Contraindications of IV rt-PA or tirofiban; 3. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys; 4. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; 5. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; 6. CT or MRI evidence of mass effect or intracranial tumor (except small eningioma); 7. CT or MRI evidence of cerebral vasculitis; 8. CTA or MRA evidence of intracranial arteriovenous malformations or aneurysms; 9. Any terminal illness with life expectancy less than 6 months.
Contact & Investigator
Congguo Yin, Doctor
PRINCIPAL INVESTIGATOR
Hangzhou First Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT05728333 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05728333 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05728333 currently recruiting?
Yes, NCT05728333 is actively recruiting participants. Contact the research team at sanghongfei1988@163.com for enrollment information.
Where is the NCT05728333 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05728333 clinical trial?
NCT05728333 is sponsored by Xinqiao Hospital of Chongqing. The principal investigator is Congguo Yin, Doctor at Hangzhou First Hospital of Zhejiang University. The trial plans to enroll 800 participants.
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