Safety and efficacy of tirofiban in acute ischemic stroke due to tandem lesions undergoing mechanical thrombectomy: A multicenter randomized clinical trial (ATILA) protocol.
Humans
Tirofiban
/ therapeutic use
Ischemic Stroke
/ drug therapy
Platelet Aggregation Inhibitors
/ adverse effects
Prospective Studies
Brain Ischemia
/ chemically induced
Treatment Outcome
Aspirin
/ adverse effects
Thrombectomy
/ adverse effects
Thrombosis
/ drug therapy
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Clinical Trials, Phase IV as Topic
Tirofiban
carotid stenting
ischemic stroke
tandem lesions
Journal
European stroke journal
ISSN: 2396-9881
Titre abrégé: Eur Stroke J
Pays: England
ID NLM: 101688446
Informations de publication
Date de publication:
03 2023
03 2023
Historique:
received:
22
07
2022
accepted:
22
11
2022
medline:
7
4
2023
entrez:
6
4
2023
pubmed:
7
4
2023
Statut:
ppublish
Résumé
In-stent thrombosis after mechanical thrombectomy (MT) worsen outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Although an optimal antiplatelet therapy is needed, the best approach to avoid in-stent thrombosis is yet to be elucidated. Low-dose intravenous tirofiban is superior to intravenous aspirin in avoiding in-stent thrombosis in patients undergoing MT plus carotid stenting in the setting of AIS due to TL. The ATILA-trial is a multicenter, prospective, phase IV, randomized, controlled (aspirin group as control), assessor-blinded clinical trial. Patients fulfilling inclusion criteria (AIS due to TL, ASPECTS ⩾ 6, pre-stroke modified Rankin Scale ⩽2 and onset <24 h) will be randomized (1:1) at MT onset to experimental (intravenous tirofiban) or control group (intravenous aspirin). Intravenous aspirin will be administered at a 500 mg single dose and tirofiban at a 500 µg bolus followed by a 200 µg/h infusion during first 22 h. All patients will be followed up to 3 months. Sample size estimated is 240 patients. The primary efficacy outcome is the proportion of patients with carotid in-stent thrombosis within the first 24 h after MT. The primary safety outcome is the rate of symptomatic intracranial hemorrhage. Secondary outcomes include functional independence defined as modified Rankin Scale 0-2, proportion of patients undergoing rescue therapy due to in-stent aggregation during MT and carotid reocclusion at 30 days. ATILA-trial will be the first clinical trial regarding the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL. NCT0522596.
Sections du résumé
Background
In-stent thrombosis after mechanical thrombectomy (MT) worsen outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Although an optimal antiplatelet therapy is needed, the best approach to avoid in-stent thrombosis is yet to be elucidated.
Hypothesis
Low-dose intravenous tirofiban is superior to intravenous aspirin in avoiding in-stent thrombosis in patients undergoing MT plus carotid stenting in the setting of AIS due to TL.
Methods
The ATILA-trial is a multicenter, prospective, phase IV, randomized, controlled (aspirin group as control), assessor-blinded clinical trial. Patients fulfilling inclusion criteria (AIS due to TL, ASPECTS ⩾ 6, pre-stroke modified Rankin Scale ⩽2 and onset <24 h) will be randomized (1:1) at MT onset to experimental (intravenous tirofiban) or control group (intravenous aspirin). Intravenous aspirin will be administered at a 500 mg single dose and tirofiban at a 500 µg bolus followed by a 200 µg/h infusion during first 22 h. All patients will be followed up to 3 months. Sample size estimated is 240 patients.
Outcomes
The primary efficacy outcome is the proportion of patients with carotid in-stent thrombosis within the first 24 h after MT. The primary safety outcome is the rate of symptomatic intracranial hemorrhage. Secondary outcomes include functional independence defined as modified Rankin Scale 0-2, proportion of patients undergoing rescue therapy due to in-stent aggregation during MT and carotid reocclusion at 30 days.
Discussion
ATILA-trial will be the first clinical trial regarding the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL.
Trial registration
NCT0522596.
Identifiants
pubmed: 37021200
doi: 10.1177/23969873221146383
pii: 10.1177_23969873221146383
pmc: PMC10069213
doi:
Substances chimiques
Tirofiban
GGX234SI5H
Platelet Aggregation Inhibitors
0
Aspirin
R16CO5Y76E
Banques de données
ClinicalTrials.gov
['NCT0522596']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
380-386Informations de copyright
© European Stroke Organisation 2022.
Déclaration de conflit d'intérêts
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Références
JAMA. 1995 Oct 4;274(13):1017-25
pubmed: 7563451
Lancet. 2012 Aug 25;380(9843):731-7
pubmed: 22748820
Eur J Neurol. 2018 Sep;25(9):1115-1120
pubmed: 29575634
J Stroke. 2021 Jan;23(1):124-127
pubmed: 33600709
J Clin Neurosci. 2008 Nov;15(11):1204-9
pubmed: 18824358
Stroke. 2017 Dec;48(12):3289-3294
pubmed: 29127270
JAMA Neurol. 2013 Feb;70(2):208-13
pubmed: 23165316
Eur J Neurol. 2018 Apr;25(4):693-700
pubmed: 29350803
Atherosclerosis. 2020 Nov;313:8-13
pubmed: 33002751
Stroke. 2005 Apr;36(4):869-71
pubmed: 15746449
Lancet. 2016 Apr 23;387(10029):1723-31
pubmed: 26898852
Front Neurol. 2019 Mar 11;10:206
pubmed: 30915023
Stroke. 2019 Aug;50(8):2250–2252
pubmed: 31577899
Lancet. 2022 Mar 12;399(10329):1059-1069
pubmed: 35240044
Front Neurol. 2018 Dec 13;9:1046
pubmed: 30619028
Front Neurol. 2019 Feb 27;10:127
pubmed: 30873105
Sci Rep. 2021 Oct 29;11(1):21326
pubmed: 34716365
Stroke. 2018 Mar;49(3):e46-e110
pubmed: 29367334
Eur J Neurol. 2019 Aug;26(8):1105-1110
pubmed: 30793464
J Neurointerv Surg. 2018 May;10(5):429-433
pubmed: 29021311