Clinical trial NCT05476081: A REAl-life Study on Short-term DAPT in Patients With Ischemic Stroke or TIA
Official title: A REAl-life Study on Short-term Dual Antiplatelet Treatment in Patients With Ischemic Stroke or Transient Ischemic Attack
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
TIA
Keywords: DAPT
Stroke
TIA
antiplatelet treatment
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 2239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a mild-to-moderate ischemic stroke or high risk TIA (according to the NIHSS Stroke scale and ABCD2 score respectively) receiving 21/90-day DAPT as secondary prevention according to clinical practice. No cutoffs of NIHSS score or ABCD2 score have been established, but we recommend to follow international guidelines.

Brief summary: The REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack (READAPT) is an observational, multicenter, prospective study involving Italian centers. The study aims at evaluating effectiveness and safety of short-term (21-90 days) dual antiplatelet treatment (DAPT) in secondary prevention of mild-to-moderate ischemic stroke or high-risk TIA.

Detailed description: The READAPT will depict the benefit/risk profile of DAPT in a clinical setting, and address subgroups of patients such as those with small cerebral vessel diseases or those treated with revascularization procedures.

Randomized clinical trials (RCTs) proved that short-term DAPT is superior over single antiplatelet treatment in reducing the ischemic recurrence risk, without a remarkable increased hemorrhagic risk thanks to the short treatment course. However, RCTs excluded patients treated with revascularization procedures (i.e. intravenous thrombolysis and thrombectomy), did not provide data on neuroimaging, and had slightly different treatment procedures such as time-to-DAPT start and antiplatelets loading dose.

The study comprises a baseline coinciding with the index event, when the investigators will collect demographics and characteristics of the event, and a 90±5 day follow-up from the index event, when patients will be screened for treatment compliance, tolerability and ischemic or hemorrhagic events. Follow-up visit can be performed remotely.

The investigators did not establish strict NIHSS or ABCD2 score cutoff for patients' inclusion, as treatment decision has to be taken independently from the study, and highly recommend physicians to adhere to guidelines. Each participating center will include all consecutive patients (hospitalized or non-hospitalized) who will meet inclusion criteria.

Data were entered in an electronic anonymized database created on the Research Electronic Data Capture (REDCap) software for the analyses hosted at University of L'Aquila. The local PI or the co-investigators will be able to upload patients' data through a single form specifically created for the study, which will include a user-friendly drop-down menu. Anonymized data will be stored on a secured server under the responsibility of University of L'Aquila. The data will be automatically backed-up once a week. Data will not be shared with unauthorized persons. Plausibility of the entered data will be checked by the study manager and the statistical data manger and data queries will be resolved by Local PI. Cases with missing data or unresolved queries will be rejected to retain only the highest quality data in the registry. Data from centers not ensuring consecutive recruitment of patients or adequate follow-up will not be included in the final database.

All analyses will be performed according to the intention-to-treat principle in all included patients completing the 90-day follow-up or having a fatal outcome event within 90 days. Descriptive statistics will be used to report baseline information. The investigators will analyze the time from index event to the first occurrence of primary and secondary outcome events with the use of a Cox proportional hazards model. Two statistical models will be used: Model 1 unadjusted and Model 2 adjusted for demographics and characteristics of the index event. P values for interaction will be calculated according to the following subgroups: type of event (ischemic stroke vs TIA), time to DAPT (≤24 hours vs \>24 hours from symptom onset), type of DAPT (aspirin+clopidogrel vs aspirin+ticagrelor), DAPT duration (≤21 vs \>21 days and ≤30 vs \>30 days), NIHSS score at onset (≤3 vs \>3 and ≤5 vs \>5), revascularization procedure (i.v. thrombolysis and/or mechanical thrombectomy vs no interventions). Hazard ratios with 95% confidence intervals will be reported. Should multiple events of the same type occur, the time to the first event will be used in the model. Data from patients who had no events during the study will be censored at the time of study termination or death. Assuming a 95% confidence interval, an estimated sample size of 1067 subjects would be required to detect a conservative 50% proportion of primary outcome occurrence with a two-sided 2.5% margin of error.

Eligibility criteria: Inclusion Criteria (all to include the patient):

* Patients with mild or moderate non-cardioembolic ischemic stroke or high-risk TIA treated with a short course of DAPT (usually 21-30 days but up to 90-day at the physician's discretion) for the acute event;
* Male or female aged \>18 years;
* Providing signed and dated informed consent;
* Willing to comply with all study procedures and to be available for the duration of the study.

Exclusion Criteria (one sufficient to exclude the patient):

* Patients receiving DAPT after endovascular procedures with stenting;
* Patients participating to any interventional RCT on stroke prevention;
* Presence of any condition which may preclude reliability of the collected information

Primary outcomes:
measure: Primary composite outcome
timeFrame: 90 days from DAPT start
Secondary outcomes:
measure: Ischemic stroke
timeFrame: 90 days from DAPT start
measure: TIA
timeFrame: 90 days from DAPT start
measure: Intracerebral hemorrhage (ICH)
timeFrame: 90 days from DAPT start
measure: Subarachnoid hemorrhage
timeFrame: 90 days from DAPT start
measure: Other intracranial hemorrhage
timeFrame: 90 days from DAPT start
measure: Mild bleeding
timeFrame: 90 days from DAPT start
measure: Moderate bleeding
timeFrame: 90 days from DAPT start
measure: Severe bleeding
timeFrame: 90 days from DAPT start
measure: Myocardial infarction
timeFrame: 90 days from DAPT start
measure: Hospitalization
timeFrame: 90 days from DAPT start
measure: Death due to vascular causes
timeFrame: 90 days from DAPT start
measure: Death due to non-vascular causes
timeFrame: 90 days from DAPT start
Other outcomes:
measure: Modified Rankin Scale (mRs)
timeFrame: 90 days from DAPT start
measure: Early DAPT discontinuation
timeFrame: 90 days from DAPT start
Locations:
city: Avezzano
country: Italy
facility: Neurology e Stroke Unit Departement, SS Filippo e Nicola Hospital
state: Abruzzo
city: Acquaviva Delle Fonti
country: Italy
facility: Department of Neurology and Stroke Unit, Ente Ecclesiastico ospedale Generale Regionale Miulli
city: Alessandria
country: Italy
facility: Department f Neurology, AO Nazionale SS Biagio and Cesare Arrigo
city: Altamura
country: Italy
facility: Department of Neurology, Murgia Hospital Fabio Perinei SS 96
city: Ancona
country: Italy
facility: Department of Neurology and Stroke Unit Ospedali Riuniti Ancona
city: Ancona
country: Italy
facility: Department of Neurology, INRCA-IRCCS "U Sestili" Hospital
city: Aosta
country: Italy
facility: Department of Neurology and Stroke Unit, "U. Parini" Hospital
city: Arezzo
country: Italy
facility: Department of Neurology, San Donato Hospital, Azienda USL Toscana Sud Est, Arezzo e Val D'Arno
city: Bari
country: Italy
facility: Department of Neurology and Stroke Unit, "Di Venere" Hospital
city: Bari
country: Italy
facility: Stroke Unit, Policlinico di Bari, Giovanni XXIII Hospital
city: Barletta
country: Italy
facility: Department of Neurology and Stroke Unit, "Mons. Dimiccoli" Hospital
city: Bassano Del Grappa
country: Italy
facility: Department of Neurology,San Bassiano Hospital
city: Belluno
country: Italy
facility: Stroke Unit, San Martino di Belluno Hospital ULSS 1
city: Benevento
country: Italy
facility: Department of Neurology, AO San Pio
city: Bologna
country: Italy
facility: Department of Neurology and Stroke Unit, Maggiore Hospital, IRCCS Istituto delle Scienze Neurologiche di Bologna
city: Bologna
country: Italy
facility: Department of Neurology, Policlinico S. Orsola-Malpighi-Clinica Neurologica Metropolitana, IRCCS Istituto delle Scienze Neurologiche di Bologna
city: Branca
country: Italy
facility: Stroke Center, Gubbio-Gualdo Tadino Hospital
city: Brescia
country: Italy
facility: Neuro-vascular Unit, AO Spedali Civili
city: Brescia
country: Italy
facility: Stroke Unit, ASST Franciacorta
city: Brescia
country: Italy
facility: Stroke Unit, Istituto Ospedaliero Fondazione Poliambulanza
city: Brindisi
country: Italy
facility: Stroke Unit, A. Perrino Hospital
city: Cagliari
country: Italy
facility: Department of Neurology and Stroke Unit, AO "G. Brotzu"
city: Caltanissetta
country: Italy
facility: Department of Neurology and Stroke Unit, S Elia Hospital
city: Caserta
country: Italy
facility: Stroke Unit, AO San Sebastiano AORN Caserta
city: Castelfranco Veneto
country: Italy
facility: Department of Neurology, San Giacomo Hospital
city: Catania
country: Italy
facility: Department of Neurology, AO Cannizzaro
city: Cefalù
country: Italy
facility: Department of Neurology, Institute G. Giglio di Cefalù
city: Cesena
country: Italy
facility: Department of Neurology and Stroke Unit, "Bufalini" Hospital
city: Chieti
country: Italy
facility: Department of Neurology and Stroke Unit, SS Annunziata Hospital
city: Cittadella
country: Italy
facility: Department of Neurology and Stroke Unit, Cittadella, AULSS6 Euganea
city: Città di Castello
country: Italy
facility: Stroke Center, USL umbria 1
city: Como
country: Italy
facility: Stroke Unit, Valduce Hospital
city: Conegliano
country: Italy
facility: Department of Neurology, Conegliano Hospital Aulss 2 Veneto
city: Crema
country: Italy
facility: Department of Neurology and Stroke Unit, ASST Maggiore Hospital of Crema
city: Cremona
country: Italy
facility: Department of Neurology, ASST Cremona
city: Cuneo
country: Italy
facility: Department of Neurology, Santa Croce Hospital
city: Desio
country: Italy
facility: Department of Neurology and Stroke Unit, Desio Hospital ASST Monza
city: Fermo
country: Italy
facility: Department of Neurology, ASUR Area Vasta 4 (ex ZT11)
city: Ferrara
country: Italy
facility: Department of NeurologY, AOU of Ferrara
city: Florence
country: Italy
facility: Department of Neurology, San Giovanni di Dio Hospital
city: Florence
country: Italy
facility: Stroke Unit, AOU Careggi
city: Genova
country: Italy
facility: Department of Neurology, Ente Ospedali Galliera Genova
city: Genova
country: Italy
facility: Stroke Unit, San Martino Hospital of Genova
city: Gorizia
country: Italy
facility: Department of Neurology, ASUGI
city: Grosseto
country: Italy
facility: Department of Neurology, USL Toscana sud est
city: Jesi
country: Italy
facility: Department of Neurology and Stroke Unit, ASUR Marche AV2 Jesi
city: L'Aquila
country: Italy
facility: Departement of Neurology, San Salvatore Hospital
city: La Spezia
country: Italy
facility: Department of Neuology, Sant'Andrea Hospital, Azienda Sanitaria Locale n. 5 "Spezzino" La Spezia
city: Lanciano
country: Italy
facility: Department of Neurology, F Renzetti Hospital
city: Latina
country: Italy
facility: UTN, Santa Maria Goretti Hospital
city: Lecce
country: Italy
facility: Department of Neurology, Ospedale Vito Fazi
city: Legnago
country: Italy
facility: Department of Neurology, Legnago Hospital
city: Legnano
country: Italy
facility: Department of Neurology and Stroke Unit Ospedale of Legnano
city: Livorno
country: Italy
facility: Emergency Department, Azienda USL 6 Livorno
city: Lucca
country: Italy
facility: Department of Neurology, Valle del Serchio Hospital
city: Massa
country: Italy
facility: Department of Neurology, Apuane Hospital, Azienda USL Toscana Nord Ovest
city: Melegnano
country: Italy
facility: Department of Neurology, ASST Melegnano e della Martesana
city: Merate
country: Italy
facility: Department of Neurology, ASST Merate
city: Messina
country: Italy
facility: Stroke Unit, AOU Gaetano Martino
city: Mestre
country: Italy
facility: Stroke Unit, Angelo's Hospital
city: Milano
country: Italy
facility: Department of Neurology and Stroke Unit, Humanitas
city: Milano
country: Italy
facility: Department of Neurology and Stroke Unit, IRCCS Istituto Auxologico Italiano, San Luca Hospital
city: Milan
country: Italy
facility: Stroke Unit, Istituto Clinico Città Studi
city: Mirano
country: Italy
facility: Department of Neurology, Mirano ULSS 3 Serenissima
city: Modena
country: Italy
facility: Stroke Unit, "S.Agostino-Estense" Hospital, AOU of Modena
city: Moncalieri
country: Italy
facility: Stroke Unit, Santa Croce Hospital
city: Monza
country: Italy
facility: Department of Neurology, San Gerardo Hospital and Bicocca University
city: Napoli
country: Italy
facility: Department of Neurology and Stroke Unit, Cardarelli Hospital
city: Napoli
country: Italy
facility: Stroke Unit, Ospedale del Mare
city: Novara
country: Italy
facility: Department of Neurology and Stroke Unit, AOU Maggiore della Carità
city: Novi Ligure
country: Italy
facility: Stroke Unit, San Giacomo Hospital
city: Orbassano
country: Italy
facility: Stroke Unit, AOU San Luigi Gonzaga
city: Padova
country: Italy
facility: Stroke Unit, Azienda Ospedale Università
city: Palermo
country: Italy
facility: Department of Neurology and Stroke Unit, ARNAS Civico of Palermo
city: Palermo
country: Italy
facility: Department of Neurology, Villa Sofia Hospital
city: Palermo
country: Italy
facility: Department of Neurophysiopathology and Stroke Unit, AOUP Paolo Giaccone
city: Palermo
country: Italy
facility: Stroke Unit, Buccheri La Ferla Hospital
city: Parma
country: Italy
facility: Department of neurology, Azienda Ospedaliero-Universitario di Parma
city: Parma
country: Italy
facility: Stroke Unit, Fidenza AUSL PR
city: Pavia
country: Italy
facility: Cerebrovascula disease and Stroke Unit neurological Intitute IRCCS Mondino
city: Perugia
country: Italy
facility: Stroke Unit, AOUUD Santa Maria della Misericordia
city: Pescara
country: Italy
facility: Department of Neurology ande Stroke Unit, Pescara Hospital
city: Peschiera Del Garda
country: Italy
facility: Stroke Unit, Pederzoli Hospital
city: Piacenza
country: Italy
facility: Department of Neurology, AUSL Piacenza
city: Pietra Ligure
country: Italy
facility: Departement of Neurology and Stroke Center, S.Corona Hospital
city: Pinerolo
country: Italy
facility: Department of Neurology and Stroke Unit, E. Agnelli Hospital
city: Pisa
country: Italy
facility: Department of Neurology, Azienda ospedaliera e universitaria Pisana
city: Pistoia
country: Italy
facility: Department of Neurology, San Jacopo Hospital
city: Potenza
country: Italy
facility: Stroke Unit, AO"San Carlo"
city: Ragusa
country: Italy
facility: Department of Neurology, Maria Paternò Arezzo Hospital
city: Ravenna
country: Italy
facility: Department of Neurology and Stroke Unit, Santa Maria delle Croci Hospital
city: Reggio Calabria
country: Italy
facility: Stroke Unit, AO "Bianchi-Melacrino-Morelli"
city: Reggio Emilia
country: Italy
facility: Department of Neurology and Stroke Unit, Arcispedale Santa Maria Nuova
city: Rimini
country: Italy
facility: Department of Neurology, Infermi di Rimini Hospital
city: Roma
country: Italy
facility: Unità di trattamento neurovascolare, Azienda Ospedaliero Universitaria Policlinico Umberto I
city: Rome
country: Italy
facility: Department of Neurology and Stroke Unit, Sant'Eugenio Hospital
city: Rome
country: Italy
facility: Department of Neurology and Stroke Unit, Systems Medicin, Policlinico Tor Vergata
city: Rome
country: Italy
facility: Department of Neurology, Ospedale Fatebenefratelli
city: Rome
country: Italy
facility: Department of Neurology, Policlinico Gemelli
city: Rome
country: Italy
facility: Department of Neurology, SS Filippo Neri Hospital
city: Rome
country: Italy
facility: Stroke Unit, AO San Camillo
city: Rome
country: Italy
facility: Stroke Unit, AOU Sant'Andrea
city: Rovigo
country: Italy
facility: Stroke Unit, Ospedale Rovigo, ULSS 18
city: Salerno
country: Italy
facility: Department of Neurology, Presidio ospedaliero Umberto I Nocera Inferiore
city: San Benedetto Del Tronto
country: Italy
facility: Department of Neurology, Madonna del Soccorso Hospital
city: San Fermo Della Battaglia
country: Italy
facility: Department of Neurology, ASST Lariana, Sant'Anna Hospital
city: San Giovanni Rotondo
country: Italy
facility: Department of Neurology, Casa sollievo della sofferenza
city: Sassari
country: Italy
facility: Stroke Unit, AOU
city: Savigliano
country: Italy
facility: Department of Neurology, SS. Annunziata Hospital
city: Siena
country: Italy
facility: Stroke Unit, Azienda ospedaliera universitaria Senese
city: Siracusa
country: Italy
facility: Department of Neurology and Stroke Unit, Umberto I Hospital
city: Sulmona
country: Italy
facility: Department of Neurology, SS Annunziata Hospital
city: Terni
country: Italy
facility: Department of Neurology and Stroke Unit, AO Santa Maria of Terni
city: Torino
country: Italy
facility: Department of Neurology and Stroke Unit, San Giovanni Bosco Hospital
city: Torino
country: Italy
facility: Neuro-vascular Unit, Maria Vittoria Hospital
city: Trapani
country: Italy
facility: Department of Neurology and Stroke Unit, ASP of Trapani
city: Trento
country: Italy
facility: Stroke Unit, Santa Chiara Hospital
city: Treviso
country: Italy
facility: Department of Neurology, Cà Foncello Hospital
city: Trieste
country: Italy
facility: Department of Neurology, Azienda Ospedaliera-Universitaria Giuliano Isontina
city: Udine
country: Italy
facility: Department of Neurology and Rehabilitation, ASUR
city: Varese
country: Italy
facility: Department of Neurology and Stroke Unit, ASST Settelaghi
city: Venezia
country: Italy
facility: Department of Neurology, SS Giovanni e Paolo Hospital, Aulss3 Serenissima Veneto
city: Vercelli
country: Italy
facility: Department of Neurology, Sant'Andrea Hospital
city: Vicenza
country: Italy
facility: Department of Neurology and Stroke Unit, Arzignano Azienda ULSS 8 Berica
city: Vicenza
country: Italy
facility: Department of Neurology and Stroke Unit, San Bortolo Hospital
city: Vimercate
country: Italy
facility: Stroke Unit, ASST Vimercate
city: Vittoria
country: Italy
facility: Department of Neurology and Stroke Unit, Guzzardi Hospital
Study officials:
affiliation: Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila
name: Simona Sacco, MD
role: STUDY_CHAIR
References:
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