Using intra-arterial thrombolysis after thrombectomy for posterior circulation strokes

Intra-arterial Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion in the Posterior Circulation (IAT-TOP)

This study is testing if giving a specific medication after a successful stroke procedure can help adults with certain types of strokes in the back of the brain feel better and recover more effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 376 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05897554 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of intra-arterial alteplase administered after successful endovascular thrombectomy in patients with acute ischemic strokes affecting the posterior circulation. The study aims to determine if this approach can improve neurological outcomes compared to standard care. Participants will be adults aged 18 to 80 who have experienced specific types of posterior circulation strokes and have undergone thrombectomy with a satisfactory result. The trial will include an interim analysis to assess early outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with posterior circulation ischemic stroke who have undergone successful thrombectomy.

Not a fit: Patients with anterior circulation strokes or those with significant comorbidities that may affect treatment outcomes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to better neurological recovery for patients suffering from posterior circulation strokes.

How similar studies have performed: Previous studies have shown promising results for intra-arterial thrombolysis in anterior circulation strokes, but this approach in posterior circulation strokes is less explored and may provide novel insights.

Eligibility criteria

Inclusion Criteria:

1. Symptoms and signs compatible with ischemia in the posterior circulation;
2. Basilar artery occlusion or vertebral artery occlusion without antegrade flow to the basilar artery confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA);
3. Age ≥18 years and ≤80 years;
4. Premorbid mRS ≤1;
5. National Institutes of Health Stroke Score (NIHSS) ≥6 at admission；
6. PC-ASPECTS on CT/CTA-Source Images/MRI-DWI 6-10；
7. Treated with endovascular thrombectomy (EVT) resulting in an eTICI score ≥2b50 at end of the procedure；
8. Time from symptom onset to randomization\<24 hours, including wake-up stroke and unwitnessed stroke; Time of onset of symptoms is defined as "last known well" (LKW) if symptoms are not witnessed or time of estimated basilar artery occlusion (defined as the time of sudden onset of basilar artery stroke symptoms, with no consideration of any preceding minor prodromal symptoms, as adjudicated by two neurologists) if symptoms are witnessed;
9. Informed consent obtained from the patient or his/her legal representative.

Exclusion Criteria:

1. Contraindication to Intravenous Thrombolysis (except time to treatment);
2. Complete clinical recovery in the angiography suite by end of MT procedure;
3. More than 3 passes of thrombectomy device;
4. Dissection of occluded artery or intraoperative bleeding on DSA after thrombectomy;
5. Patients in sedation and intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation;
6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
7. Bilateral dilated pupils;
8. Severe contrast allergy or absolute contraindication to iodinated contrast;
9. Systolic pressure \>185 mmHg or diastolic pressure \>110 mmHg, and cannot be controlled by antihypertensive drugs;
10. Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L);
11. Platelet \<50\*10\^9/L, or aPTT \>40 s, or PT \>15 s;
12. Known genetic or acquired bleeding diathesis, deficiency of anticoagulant factors, or oral anticoagulant drugs and INR \> 1.7, or treated with direct oral anticoagulant agents in the prior 48 hours;
13. Known Severe renal Failure as defined by a serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \[GFR\] \<30, or patient requires hemodialysis or peritoneal dialysis;
14. Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.);
15. Presumed vasculitis or septic embolization;
16. Suspicion of aortic dissection;
17. The patient has neurological disease or mental disorder before onset, which affects the assessment of the condition;
18. Females who are pregnant or in lactation;
19. Participating in other clinical trials that could confound the evaluation of the study;
20. Other circumstances that the investigator considers inappropriate for participation or may pose a significant risk to patients.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University. — Beijing, China (Recruiting)

Conditions Acute Ischemic Stroke; Arterial Thrombosis; Posterior Circulation Brain Infarction; Intra-arterial thrombolysis; Alteplase; Large vessel occlusion; Mechanical thrombectomy; Endovascular treatment