NCT06548971From ClinicalTrials.govRecruiting

Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)

Safety and Efficacy of Treatment With Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT): A Multicenter, Randomized, Placebo-controlled, Clinical Trial

Acute Ischemic Stroke
Cerebral Infarction

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Capital Medical University
Enrolment target: 1,184
Started: 7 November 2024
Main results due: December 2027
Study sites: 119
Registry updated: 24 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Age ≥18 years old;
2. Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well, and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.
3. Residual NIHSS score \> 5 points assessed 1 hour after initiation of intravenous thrombolysis and prior to randomization.
4. Informed consent obtained from patients or an authorized representative.

Exclusion Criteria:

1. Stroke caused by definite large vessel occlusion (including A1/A2 segments of the anterior cerebral artery, M1/M2 segments of the middle cerebral artery, P1/P2 segments of the posterior cerebral artery, intracranial/extracranial segments of the internal carotid artery, basilar artery, and bilateral vertebral artery occlusion) confirmed by vessel imaging (including computed tomography angiography \[CTA\] or magnetic resonance angiography \[MRA\]), or scheduled for endovascular treatment (including mechanical thrombectomy, intra-arterial thrombolysis, and angioplasty).
2. Intracranial hemorrhage confirmed by imaging post-thrombolysis.
3. Definite or suspected cardioembolic stroke.
4. Stroke caused by other determined causes, including nonatherosclerotic vasculopathies (moyamoya disease, artery dissection, arteritis), hypercoagulable states, or hematological disorders.
5. Use of antiplatelet therapy within one week prior to stroke onset, novel anticoagulant drugs within 48 hours prior to stroke onset, or treatment with warfarin with an international normalized ratio (INR)\>1.7.
6. Prior history of moderate or severe ischemic stroke events with residual neurological disability.
7. Pre-stroke mRS score \> 1.
8. Severe consciousness disturbance with NIHSS item 1a (level of consciousness) ≥ 2 points.
9. Post-thrombolysis imaging indicates an infarct area larger than 1/2 responsible artery supply area.
10. Known contraindications for antiplatelet therapy, such as coagulation disorders, or systemic bleeding
11. History of aspirin allergy.
12. Anticipated indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state)
13. Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR \< 30 mL/min or serum creatinine \> 220 μmol/L \[2.5 mg/dL\]), severe hepatic insufficiency (serum alanine aminotransferase \[ALT\] \>2 times the upper limit of normal, or serum aspartate aminotransferase \[AST\] \>2 times the upper limit of normal), severe heart failure (New York Heart Association \[NYHA\] Functional Classification Class III or IV)
14. Severe non-cardiovascular complications with an expected survival of less than 6 months.
15. Unavailability for follow-up.
16. Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up.
17. Current participation in another therapeutic study with ongoing treatment and follow-up.
18. Other conditions that make the patient unsuitable for participation in the study as determined by the investigator.

What this study is about

In the sponsor’s own words, from the registry.

Stroke is the second leading cause of death worldwide, and ischemic stroke is the most frequent type. Intravenous thrombolysis with recombinant tissue plasminogen activator within 4.5 hours of symptom onset is the most effective therapy for patients with acute ischemic stroke. However, ischemic stroke progression and early reocclusion are not an uncommon phenomenon in patients after intravenous thrombolysis, resulting in neurological deterioration, which is associated with unfavorable functional outcomes. The underlying mechanism mainly involves the augmented platelet activation, triggered by the activated coagulation cascade during thrombolysis, which peaks within 2 hours of initiating rt-PA administration. Therefore, early antiplatelet therapy following intravenous thrombolysis represents a promising therapeutic approach to prevent neurological deterioration and improve the functional outcome of patients treated with intravenous thrombolysis.

Currently, guidelines recommend initiating antiplatelet therapy 24 hours after intravenous thrombolysis due to the potential risk of increased bleeding. The safety and efficacy of early antiplatelet treatment following intravenous thrombolysis in patients with acute ischemic stroke remain clear.

The study aims to test the hypothesis that in patients with acute ischemic stroke treated with intravenous thrombolysis, early administration of oral aspirin will improve functional outcomes without increasing the risk of intracranial hemorrhage.

Study sites(119)

The Third The People's Hospital Of Bengbu
Bengbu, Anhui, China
Recruiting
Huaiyuan county traditional Chinese medicine hospital
Bengbu, Anhui, China
Recruiting
Bozhou people's hospital
Bozhou, Anhui, China
Not yet recruiting
Huaibei people's hospital
Huaibei, Anhui, China
Recruiting
Suzhou municipal hospital
Suzhou, Anhui, China
Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Recruiting
Aerospace central hospital
Haidian, Beijing Municipality, China
Recruiting
Beijing Pinggu District Hospital
Pinggu, Beijing Municipality, China
Recruiting
Beijing Luhe Hospital affiliated to Capital Medical University
Tongzhou, Beijing Municipality, China
Recruiting
Fujian university affiliated provincial hospital
Fuzhou, Fujian, China
Recruiting
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, China
Recruiting
Xiamen Xinglin hospital
Xiamen, Fujian, China
Recruiting
Zhangzhou Hospital of Fujian Province
Zhangzhou, Fujian, China
Recruiting
Heyuan people's hospital
Heyuan, Gangdong, China
Recruiting
Brain Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China
Recruiting
People's Hospital of Longchuan County
Heyuan, Guangdong, China
Not yet recruiting
Guigang people's hospitalv
Guigang, Guangxi, China
Recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Recruiting
The Second Affiliated Hospital of Guizhou Medical University
Kaili, Guizhou, China
Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Recruiting
Cangzhou combination of Chinese traditional and western medicine hospital
Cangzhou, Hebei, China
Recruiting
Cangzhou Central Hospital
Cangzhou, Hebei, China
Recruiting
Botou traditional Chinese medicine hospital
Cangzhou, Hebei, China
Recruiting
Xian county People's Hospital
Cangzhou, Hebei, China
Recruiting
Hejian city People's Hospital
Cangzhou, Hebei, China
Recruiting
Handan Central Hospital
Handan, Hebei, China
Recruiting
Handan first hospital
Handan, Hebei, China
Recruiting
Ci county people's hospital
Handan, Hebei, China
Recruiting
Handan Yongnian District First Hospital
Handan, Hebei, China
Recruiting
Yutian county Hospital
Tangshan, Hebei, China
Recruiting
Qinghe county people's hospital
Xingtai, Hebei, China
Recruiting
Xingtai ninth hospital
Xingtai, Hebei, China
Recruiting
Harbin 242 hospital
Haerbin, Heilongjiang, China
Recruiting
Jiamusi university hongda hospital
Jiamusi, Heilongjiang, China
Recruiting
Mudanjiang first people's hospital
Mudanjiang, Heilongjiang, China
Recruiting
The First Hospital Of Qiqihar
Qiqihar, Heilongjiang, China
Recruiting
Hua county People's Hospital
Anyang, Henan, China
Recruiting
Jun county people's hospital
Hebi, Henan, China
Recruiting
Jiaozuo Second People's Hospital
Jiangzuo, Henan, China
Recruiting
Kaifeng central hospital
Kaifeng, Henan, China
Recruiting
First People's Hospital of Luoyang
Luoyang, Henan, China
Recruiting
Luoyang yiluo hospital
Luoyang, Henan, China
Recruiting
Mengjin county people's hospital
Luoyang, Henan, China
Recruiting
Luoyang Yanshi People's Hospital
Luoyang, Henan, China
Recruiting
Nanyang Central Hospital
Nanyang, Henan, China
Recruiting
Nanyang nanshi hospital
Nanyang, Henan, China
Recruiting
Nanle county people's hospital
Puyang, Henan, China
Recruiting
Huanghe Sanmenxia hospital
Sanmenxia, Henan, China
Recruiting
Shangqiu Third People's Hospital
Shangqiu, Henan, China
Recruiting
Sui county traditional Chinese medicine hospital
Shangqiu, Henan, China
Recruiting
Shangqiu First People's Hospital
Shangqiu, Henan, China
Recruiting
Sui county people's hospital
Shangqiu, Henan, China
Recruiting
Ningling county people's hospital
Shangqucun, Henan, China
Recruiting
Xixian county people's hospital
Xinyang, Henan, China
Not yet recruiting
Xihua People's Hospital
Zhoukou, Henan, China
Recruiting
Shenqiu county People's Hospital
Zhoukou, Henan, China
Recruiting
Luyi county people's hospital
Zhoukou, Henan, China
Recruiting
Zhumadian Central Hospital
Zhumadian, Henan, China
Recruiting
The Third People's Hospital of Hubei Province
Hainan, Hubei, China
Recruiting
Jingmen people's hospital
Jingmen, Hubei, China
Not yet recruiting

Showing 60 of 119 sites — filter to narrow it down. 106 of the 119 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06548971. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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