Tirofiban Given Early After Clot-Dissolving Treatment in Acute Ischemic Stroke
Tests tirofiban after clot-dissolving treatment in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Key facts
- Where
- Dalian, Fuyang, Ganzhou, Jingdezhen, Jiujiang, Longyan, Mianyang, and Xiangtan, ChinaSee the 10 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a stroke caused by a blood clot, were treated with a clot-dissolving drug, and still have clear problems with movement or other functions.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke treated with intravenous thrombolysis (tenecteplase or alteplase). Between 2 and 24 hours after thrombolysis there was no real improvement, a worsening, or a back-and-forth change in the stroke score (NIHSS). Before randomization, NIHSS score is 4 or more, or the motor score of one limb is 2 or more.
- Earlier treatment
- Must have had intravenous thrombolysis with tenecteplase or alteplase.
Main reasons for not taking part
- Bleeding in the brain seen on CT or MRI after thrombolysis
- Blocked large or medium brain artery seen on imaging
- History of atrial fibrillation or a suspected heart-related clot
- Platelet count below 100×10⁹/L, or kidney function (eGFR) below 30 mL/min
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Where in China
- Dalian Central HospitalDalian, ChinaNo longer taking part
- Taihe County People's HospitalFuyang, ChinaNo longer taking part
- Ganzhou People's HospitalGanzhou, ChinaNo longer taking part
- Xingguo People's Hospital, Xinguo Hospital of Gannan Medical UniversityGanzhou, ChinaNo longer taking part
- Jingdezhen First People's HospitalJingdezhen, ChinaNo longer taking part
- The First People's Hospital of Jingdezhen CityJingdezhen, ChinaNo longer taking part
- Jiujiang First People's HospitalJiujiang, ChinaNo longer taking part
- Longyan First Hospital of Fujian Medical UniversityLongyan, ChinaNo longer taking part
- The First People's Hospital of Mianyang (Mianyang 404 Hospital)Mianyang, ChinaNo longer taking part
- Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)Xiangtan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xinqiao Hospital of Chongqing
- Trial code
- NCT07842185
- Record updated
- 6 November 2026
- Original description
Acute ischemic stroke is a leading cause of disability and mortality among dults in China. Although intravenous thrombolysis serves as first-line reperfusion therapy, nearly half of patients fail to achieve vascular recanalization. The reocclusion rate ranges from 14% to 34%, and many patients are left with residual neurological deficits. Early antiplatelet therapy initiated after thrombolysis may sustain persistent reperfusion and improve prognosis. However, current guidelines generally recommend delaying antiplatelet treatment until 24 hours post-thrombolysis due to bleeding risks, and direct evidence for the optimal initiation timing remains lacking. Tirofiban is a rapidly acting, short-half-life, reversible glycoprotein IIb/IIIa receptor antagonist. Previous studies indicate its potential benefits and acceptable safety when administered after intravenous thrombolysis.Read full original descriptionShow less
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke(INSTANT-2)
Acute ischemic stroke is a leading cause of disability and mortality among dults in China. Although intravenous thrombolysis serves as first-line reperfusion therapy, nearly half of patients fail to achieve vascular recanalization. The reocclusion rate ranges from 14% to 34%, and many patients are left with residual neurological deficits. Early antiplatelet therapy initiated after thrombolysis may sustain persistent reperfusion and improve prognosis. However, current guidelines generally recommend delaying antiplatelet treatment until 24 hours post-thrombolysis due to bleeding risks, and direct evidence for the optimal initiation timing remains lacking. Tirofiban is a rapidly acting, short-half-life, reversible glycoprotein IIb/IIIa receptor antagonist. Previous studies indicate its potential benefits and acceptable safety when administered after intravenous thrombolysis.
This is a multicenter, open-label, endpoint-blinded randomized controlled trial. A total of 1192 non-cardioembolic patients without large or medium vessel occlusion and with residual neurological deficits (NIHSS ≥4) after thrombolysis will be enrolled. Participants will be randomly allocated to the tirofiban 24-hour group, tirofiban 48-hour group. The primary outcome is the proportion of patients with excellent functional outcome defined as modified Rankin Scale (mRS) score 0-1 at 90 days. Symptomatic intracranial hemorrhage and neurological outcomes will also be evaluated. The study aims to determine the optimal duration of tirofiban treatment after thrombolysis and provide high-level evidence for precise interventions in the acute phase of stroke.
Inclusion: Aged ≥18 years; Diagnosed with acute ischemic stroke in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023, and treated with intravenous thrombolysis using tenecteplase or alteplase; No substantial neurological improvement within 2-24 hours after intravenous thrombolysis (defined as an increase in NIHSS score, or a decrease of 0 or 1 point), neurological deterioration (defined as an increase in NIHSS score of ≥2 points compared with baseline), or neurological fluctuation (defined as an increase of ≥4 points followed by a decrease of ≥4 points in NIHSS score compared with baseline); NIHSS score ≥4 points or motor score of a single limb ≥2 points before randomization; Written informed consent obtained from the patient or legal surrogate.
Exclusion: Concurrent participation in another clinical trial; Intracranial hemorrhage confirmed by CT or MRI from after intravenous thrombolysis up to randomization; History of atrial fibrillation or suspected cardioembolism; Pre-existing neurological or psychiatric disorders that would interfere with neurological function assessment; History of bleeding diathesis, severe cardiac, hepatic or renal disease, or sepsis; Any terminal illness with life expectancy < 6 months; Other conditions deemed ineligible by the investigator; Platelet count < 100×10⁹/L on complete blood count; Renal insufficiency with estimated glomerular filtration rate (eGFR) < 30 mL/min; Large- or medium-vessel occlusion identified on CTA/MRA/DSA (internal carotid artery; M1, M2 or M3 segment of the middle cerebral artery; A1, A2 or A3 segment of the anterior cerebral artery; P1, P2 or P3 segment of the posterior cerebral artery; vertebrobasilar artery); Pregnant or breastfeeding women; Brain tumor with mass effect on imaging (excluding small meningioma); Intracranial aneurysm or arteriovenous malformation.