Home › Trials › NCT06548971

Early use of antiplatelet therapy after thrombolysis for stroke

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

Phase 3 Interventional Capital Medical University · NCT06548971

This study tests if giving aspirin right after stroke treatment can help adults feel better and prevent further problems.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1184 (estimated)
Ages18 Years and up
SexAll
SponsorCapital Medical University Academic / other
Locations71 sites (Bengbu, Anhui and 70 other locations)
Trial IDNCT06548971 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of early antiplatelet therapy, specifically aspirin, administered after intravenous thrombolysis in patients with acute ischemic stroke. The study aims to determine if this approach can prevent neurological deterioration and improve functional outcomes in patients who have received thrombolysis treatment. Participants must be adults who have undergone thrombolysis within a specified time frame and meet certain neurological criteria. The trial compares the outcomes of those receiving aspirin to those receiving a placebo and best medical management.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute ischemic stroke and received intravenous thrombolysis within 4.5 hours of symptom onset.

Not a fit: Patients with strokes caused by large vessel occlusions or those scheduled for endovascular therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of neurological deterioration and improve recovery outcomes for stroke patients.

How similar studies have performed: While the approach of early antiplatelet therapy post-thrombolysis is promising, it remains a relatively novel strategy with limited prior success in similar studies.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Bengbu, Anhui and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Ischemic StrokeCerebral InfarctionAcute ischemic strokeIntravenous thrombolysisEarly neurological deteriorationAspirin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.