Intra-arterial Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke in the Posterior Circulation (IAT-TOP)

NCT05897554 | Completed DMC

• 1 other identifier: IAT-TOP
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

The CHOICE study suggested that the use of adjunct intra-arterial alteplase after successful endovascular reperfusion in large vessel occlusion acute ischemic strokes may result in a greater likelihood of excellent neurological outcome at 90 days. However, CHOICE was a phase-2 trial and almost exclusively enrolled anterior circulation occlusions. Therefore, data on the safety and efficacy of post-endovascular reperfusion IAT in posterior circulation stroke is lacking. In general, anterior circulation strokes are associated with a higher risk of ICH than posterior circulation strokes. Therefore, we believe it might be safer to perform post-endovascular reperfusion IAT posterior circulation stroke. Also, there are more perforator artery in the posterior circulation, IAT would be more likely to show its benefit. Therefore, we would like to explore IA rt-PA for posterior circulation stroke after successful MT in our RCT. In this study, one interim analysis will be performed when the enrollment volume reaches 50% of the total sample size (188 cases). DSMB will determine the premature termination or continuity of research.

Conditions

Acute Ischemic Stroke; Arterial Thrombosis; Posterior Circulation Brain Infarction

Keywords

Intra-arterial thrombolysis; Alteplase; Large vessel occlusion; Mechanical thrombectomy; Endovascular treatment

Outcome Measures

Primary Outcomes (1)

• Rate of modified Rankin Scale (mRS) score of 0-2

  The mRS score range from 0 (no disability) to 6 (death)

  90 days (±7 days) after randomization

Secondary Outcomes (10)

• Change of eTICI

  Before intra-arterial thrombolysis vs. immediately after the completion of intra-arterial thrombolysis

• Rate of mRS score of 0-3

  90 days (±7 days) after randomization

• Proportional distribution of modified Rankin Score

  90 days (±7 days) after randomization

• Improvement of the National Institutes of Health Stroke Scale (NIHSS) score

  48 hours (±12 hours) after randomization

• Rate of early neurological improvement

  48 hours (±12 hours) after randomization

Study Arms (2)

Successful mechanical thrombectomy plus intra-arterial alteplase group

EXPERIMENTAL

For patients in the successful MT plus intra-arterial alteplase group, after successful recanalization, neurointerventionalists administered intra-arterial thrombolysis with alteplase according to protocol. The angiographic scores will be assessed after intra-arterial thrombolysis.

Drug: intra-arterial alteplase

Successful mechanical thrombectomy only group

NO INTERVENTION

For patients in the successful MT only group, the choice of MT strategy will be made by the qualified neurointerventionalist, including stent retriever, aspiration and a combination technology. Patients who underwent more than 3 thrombectomy procedures were excluded from the study. Rescue therapy was performed at the discretion of the neurointerventionalist in case of the grade of stenosis at the occlusion site was presented to be more than 70% after MT.

Interventions

intra-arterial alteplase DRUG

For patients in the successful MT plus intra-arterial alteplase group, after successful recanalization, neurointerventionalists administered intra-arterial thrombolysis with alteplase according to protocol. The angiographic scores will be assessed immediately after intra-arterial thrombolysis.

Also known as: Intraarterial alteplase recombinant tissue plasminogen activator (r-tPA)

Successful mechanical thrombectomy plus intra-arterial alteplase group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms and signs compatible with ischemia in the posterior circulation;
• 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);
• Age ≥18 years and ≤80 years;
• Premorbid mRS ≤1;
• National Institutes of Health Stroke Score (NIHSS) ≥6 at admission；
• PC-ASPECTS on CT/CTA-Source Images/MRI-DWI 6-10；
• Treated with endovascular thrombectomy (EVT) resulting in an eTICI score ≥2b50 at end of the procedure；
• 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;
• Informed consent obtained from the patient or his/her legal representative.

You may not qualify if:

• Contraindication to Intravenous Thrombolysis (except time to treatment);
• Complete clinical recovery in the angiography suite by end of MT procedure;
• More than 3 passes of thrombectomy device;
• Dissection of occluded artery or intraoperative bleeding on DSA after thrombectomy;
• 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;
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
• Bilateral dilated pupils;
• Severe contrast allergy or absolute contraindication to iodinated contrast;
• Systolic pressure \>185 mmHg or diastolic pressure \>110 mmHg, and cannot be controlled by antihypertensive drugs;
• Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L);
• Platelet \<50\*10\^9/L, or aPTT \>40 s, or PT \>15 s;
• 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;
• 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;
• Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.);
• Presumed vasculitis or septic embolization;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University.

Beijing, 100053, China

Location

Related Publications (1)

• Yang B, Bai X, Yi T, Wang H, Liu Y, Ma L, Liu S, Wu S, Zhang L, Peng Y, Nogueira RG, Chen W, Jiao L. Intra-arterial Alteplase Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke in the Posterior Circulation (IAT-TOP): Study protocol and rationale. Int J Stroke. 2025 Jul;20(6):750-755. doi: 10.1177/17474930251313940. Epub 2025 Jan 23.

  PMID: 39754489 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Brain Infarction

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 9, 2023
• Study Start: August 11, 2023
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CN (1)