Intra-arterial Alteplase after successful reperfusion following mechanical thrombectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter trial randomizes adults with anterior circulation large vessel occlusion who achieve successful reperfusion after endovascular thrombectomy to receive adjunctive intra-arterial alteplase plus standard care or standard care alone. It uses a PROBE design with blinded outcome assessment and aims to see if the addition improves functional recovery at 90 days, defined as mRS 0-1. Primary safety concerns include symptomatic intracranial hemorrhage and death. The trial targets patients treated within 24 hours of onset and who meet imaging and vascular criteria. Enrollment involves several hospitals in Vietnam in collaboration with local stroke organizations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years old.
2. No significant pre-stroke functional disability (pre-stroke mRS 0-1)
3. Clinical diagnosis of acute ischemic stroke with anterior LVO
4. Time from symptom onset to randomization within 24 hours, including wake-up stroke or unwitness stroke; the onset time refers to "Last Known Well" (LKW).
5. Baseline NIHSS of 6 - 25
6. Non-contrast CT (NCCT) or diffusion-weighted imaging (DWI)-MRI Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6. For patients with available perfusion imaging (CTP/MRP), additional criteria include: Ischemic core volume ≤ 70mL; Mismatch volume ≥ 15 ml; Mismatch ratio ≥ 1.8
7. Evidence of oclussion of the intracranial segment of the internal carotid artery (ICA), or M1 or M2 segment of the middle cerebral artery (MCA) on CT angiography (CTA) or MR angiography (MRA)
8. Treated with EVT resulting eTICI score of 2b-3. Patients with an eTICI score of 2b-3 on the diagnostic cerebral angiography before MT are also eligible for the study.
9. Informed consent obtained from patient or acceptable patient surrogate.

Exclusion Criteria:

1. mRS score ≥ 2 before stroke onset
2. Anticipated advanced comorbid disease with life expectancy \< 12 months
3. Acute head trauma
4. Severe hypertension with SBP \> 185 mmHg or DBP \> 110 mmHg and refractory to treatment.
5. Any active or recent major bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 30 days.
6. Contraindication to recombinant human tissue plasminogen activator (rt-PA) (except time to therapy).
7. Women who are pregnant at stroke onset.
8. Recent intracranial surgery in the past 30 days.
9. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency.
10. Coagulation disorder with INR \> 1.7 or use of new oral anticoagulants (within 48 hours of symptom onset).
11. Platelet count \< 50 G/L.
12. Blood glucose \< 2,8 mmol/L (50 mg/dl) or \> 22,2 mmol/L (400 mg/dl)
13. Known severe renal insufficiency with glomerular filtration rate \< 30 ml/min or blood creatinine \> 220 µmol/L (2,5 mg/dl).
14. Requiring hemodialysis or peritoneal dialysis
15. Suspected vascular occlusion as a result of infective endocarditis
16. Suspected cerebral vasculitis based on medical history and/or angiographic evaluation.
17. Suspected aortic dissection
18. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast, heparin.
19. Acute ischemic stroke with significant mass effect or evidence of midline shift on baseline neuroimaging, or clinical signs of brain herniation
20. Suspected acute ischemic stroke involving multiple vascular territories or occlusion of two or more distinct vascular systems on neuroimaging
21. Evidence of intracranial hemorrhage (including hemorrhagic transformation) on neuroimaging
22. Brain tumor (with significant mass effect)
23. Stent placement and other situations during the EVT procedure that requires antiplatelet therapy or anti coagulation within the first 24 hours.
24. Extracranial segment occlusion of the ICA and post-procedural etiology suggests vascular dissection.
25. Intravenous heparin administration (however, heparinised saline flushes are allowed)
26. Procedure time \> 90 min
27. Number of thrombectomy passes \> 5
28. Complications occur during EVT: Vascular rupture, dissection, or contrast extravasation
29. Complete clinical recovery after rapid recanalization.
30. Participation in other interventional randomized clinical trials that may confound the outcome assessment of the study.
31. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
32. Unlikely to be available for 90-day follow-up

Where it's running

• Chau Doc General Hospital
  An Giang, Vietnam Recruiting
• Can Tho Central General Hospital
  Can Tho, Vietnam Recruiting
• Da Nang Hospital
  Da Nang, Vietnam Recruiting
• Viet Tiep Friendship Hospital
  Haiphong, Vietnam Recruiting
• Hanoi Medical University Hospital
  Hà Nội, Vietnam Recruiting
• People's Hospital 115
  Ho Chi Minh City, Vietnam Recruiting

Study contacts

• Study coordinator: Thang H Nguyen, Assoc. Prof.
• Email: nguyenhuythang115@gmail.com
• Phone: +84909982115

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sivelestat added to endovascular clot retrieval for acute anterior circulation stroke

  This study tests whether giving sivelestat sodium alongside mechanical thrombectomy helps improve outcomes for adults with acute ischemic stroke due to large vessel occlusion.

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• Injecting methylprednisolone into the artery right after clot removal for large-vessel stroke

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• Comparing thrombectomy and medical management for stroke patients treated after 24 hours

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  Recruiting Tianjin Huanhu Hospital · Tianjin, Tianjin Municipality · NCT06654375

• Registry for Endovascular Treatment of Acute Ischemic Stroke

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• Registry for patients with acute ischemic stroke caused by large vessel occlusions

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  Recruiting at 4 sites Tianjin Huanhu Hospital · Tianjin, Tianjin Municipality and 3 other locations · NCT05659160

• Sevoflurane vs. Propofol for anesthesia in stroke patients undergoing clot-removal

  This study tests whether sevoflurane or propofol used for anesthesia during endovascular treatment of an acute ischemic stroke affects the final brain damage and recovery.

  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07902791

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.