Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of eTICI | Change of eTICI after intra-arterial thrombolysis | Before intra-arterial thrombolysis vs. immediately after the completion of intra-arterial thrombolysis |
| Rate of mRS score of 0-3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University. | Beijing | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42026933 | Derived | Chen W, Yang B, Bai X, Yi T, Wang H, Wen C, Liu Y, Ma L, Wu S, Liu S, Zhang L, Peng Y, Zhao Y, Song C, Cai X, Zhang G, Zheng W, Cheng T, Wei L, Xu L, Liu W, Han H, Cao H, Chang W, Fang P, Xu C, Ju D, Liu Y, Zhang J, Li J, Wang E, Zhang G, Yu J, Zeng G, Chen F, Li X, Dai Y, Guo X, Wu Y, Nguyen TN, Fischer U, Qureshi AI, Nogueira RG, Ji X, Jiao L; IAT-TOP Investigators. Intra-arterial Alteplase Thrombolysis After Successful Thrombectomy for AIS in the Posterior Circulation: The IAT-TOP Randomized Clinical Trial. JAMA Neurol. 2026 Apr 24:e261074. doi: 10.1001/jamaneurol.2026.1074. Online ahead of print. | |
| 39754489 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
The mRS score range from 0 (no disability) to 6 (death)
| 90 days (±7 days) after randomization |
| Proportional distribution of modified Rankin Score | The mRS score range from 0 (no disability) to 6 (death) | 90 days (±7 days) after randomization |
| Improvement of the National Institutes of Health Stroke Scale (NIHSS) score | The NIHSS score range from 0 (no deficit) to 42 (maximum deficit) | 48 hours (±12 hours) after randomization |
| Rate of early neurological improvement | The NIHSS score 0-1 or decrease ≥8 from baseline NIHSS | 48 hours (±12 hours) after randomization |
| Improvement of the NIHSS score | The NIHSS score range from 0 (no deficit) to 42 (maximum deficit) | 7 days (±1 days) after randomization or discharge |
| EQ-5D-5L | The EQ-5D 5-Levels (EQ-5D-5L) range from 5 (no problems) to 25 (extreme problems), which deceased patients have a utility of 0. | 90 days (±7 days) after randomization |
| Barthel Index | The Barthel Index range from 0 (severe disability) to 100 (no disability) | 90 days (±7 days) after randomization |
| All-cause mortality | Death defined as a mRS score of 6 | 90 days (±7 days) after randomization |
| Rate of symptomatic intracranial hemorrhage (sICH) | The sICH was assessed based on the Heidelberg Bleeding Classification, defined as 1) ≥4 points total NIHSS at the time of diagnosis compared to immediately before worsening; 2) ≥2 point in one NIHSS category. The rationale for this is to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; 3) Leading to intubation/hemicraniectomy/EVD placement or other major medical/surgical intervention; 4) Absence of alternative explanation for deterioration. | Within 48 hours after randomization |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020520 | Brain Infarction |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided