A REAl-life Study on Short-term DAPT in Patients With Ischemic Stroke or TIA
- Registration Number
- NCT05476081
- Lead Sponsor
- University of L'Aquila
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2239
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients (single cohort study) Aspirin Patients presenting with a mild-to-moderate ischemic stroke or high risk TIA Patients (single cohort study) Clopidogrel Patients presenting with a mild-to-moderate ischemic stroke or high risk TIA Patients (single cohort study) Ticagrelor Patients presenting with a mild-to-moderate ischemic stroke or high risk TIA
- Primary Outcome Measures
Name Time Method Primary composite outcome 90 days from DAPT start Death, stroke recurrence (ischemic or hemorrhagic)
- Secondary Outcome Measures
Name Time Method TIA 90 days from DAPT start Intracerebral hemorrhage (ICH) 90 days from DAPT start Lobar or non lobar ICH
Other intracranial hemorrhage 90 days from DAPT start Subdural or epidural hematoma
Moderate bleeding 90 days from DAPT start bleeding requiring blood transfusion, but not causing hemodynamic compromise
Severe bleeding 90 days from DAPT start bleeding causing hemodynamic compromise and requiring blood transfusion, inotropic support, or surgical intervention and
Hospitalization 90 days from DAPT start hospitalization due to any cause
Ischemic stroke 90 days from DAPT start Death due to vascular causes 90 days from DAPT start Death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.
Subarachnoid hemorrhage 90 days from DAPT start Mild bleeding 90 days from DAPT start bleeding not requiring blood transfusion or causing hemodynamic compromise
Myocardial infarction 90 days from DAPT start Death due to non-vascular causes 90 days from DAPT start Death due all the other causes (i.e. infections, neoplasms etc)
Trial Locations
- Locations (127)
Neurology e Stroke Unit Departement, SS Filippo e Nicola Hospital
🇮🇹Avezzano, Abruzzo, Italy
Department of Neurology and Stroke Unit, Ente Ecclesiastico ospedale Generale Regionale Miulli
🇮🇹Acquaviva Delle Fonti, Italy
Department of Neurology, Murgia Hospital Fabio Perinei SS 96
🇮🇹Altamura, Italy
Department f Neurology, AO Nazionale SS Biagio and Cesare Arrigo
🇮🇹Alessandria, Italy
Department of Neurology and Stroke Unit Ospedali Riuniti Ancona
🇮🇹Ancona, Italy
Department of Neurology, INRCA-IRCCS "U Sestili" Hospital
🇮🇹Ancona, Italy
Department of Neurology and Stroke Unit, "U. Parini" Hospital
🇮🇹Aosta, Italy
Department of Neurology, San Donato Hospital, Azienda USL Toscana Sud Est, Arezzo e Val D'Arno
🇮🇹Arezzo, Italy
Department of Neurology and Stroke Unit, "Di Venere" Hospital
🇮🇹Bari, Italy
Stroke Unit, Policlinico di Bari, Giovanni XXIII Hospital
🇮🇹Bari, Italy
Department of Neurology and Stroke Unit, "Mons. Dimiccoli" Hospital
🇮🇹Barletta, Italy
Department of Neurology,San Bassiano Hospital
🇮🇹Bassano Del Grappa, Italy
Stroke Unit, San Martino di Belluno Hospital ULSS 1
🇮🇹Belluno, Italy
Department of Neurology, AO San Pio
🇮🇹Benevento, Italy
Department of Neurology and Stroke Unit, Maggiore Hospital, IRCCS Istituto delle Scienze Neurologiche di Bologna
🇮🇹Bologna, Italy
Department of Neurology, Policlinico S. Orsola-Malpighi-Clinica Neurologica Metropolitana, IRCCS Istituto delle Scienze Neurologiche di Bologna
🇮🇹Bologna, Italy
Neuro-vascular Unit, AO Spedali Civili
🇮🇹Brescia, Italy
Stroke Center, Gubbio-Gualdo Tadino Hospital
🇮🇹Branca, Italy
Stroke Unit, ASST Franciacorta
🇮🇹Brescia, Italy
Stroke Unit, Istituto Ospedaliero Fondazione Poliambulanza
🇮🇹Brescia, Italy
Stroke Unit, A. Perrino Hospital
🇮🇹Brindisi, Italy
Department of Neurology and Stroke Unit, AO "G. Brotzu"
🇮🇹Cagliari, Italy
Stroke Unit, AO San Sebastiano AORN Caserta
🇮🇹Caserta, Italy
Department of Neurology, San Giacomo Hospital
🇮🇹Castelfranco Veneto, Italy
Department of Neurology and Stroke Unit, S Elia Hospital
🇮🇹Caltanissetta, Italy
Department of Neurology, AO Cannizzaro
🇮🇹Catania, Italy
Department of Neurology, Institute G. Giglio di Cefalù
🇮🇹Cefalù, Italy
Department of Neurology and Stroke Unit, "Bufalini" Hospital
🇮🇹Cesena, Italy
Department of Neurology and Stroke Unit, SS Annunziata Hospital
🇮🇹Chieti, Italy
Department of Neurology and Stroke Unit, Cittadella, AULSS6 Euganea
🇮🇹Cittadella, Italy
Stroke Center, USL umbria 1
🇮🇹Città di Castello, Italy
Stroke Unit, Valduce Hospital
🇮🇹Como, Italy
Department of Neurology and Stroke Unit, ASST Maggiore Hospital of Crema
🇮🇹Crema, Italy
Department of Neurology, ASST Cremona
🇮🇹Cremona, Italy
Department of Neurology, Conegliano Hospital Aulss 2 Veneto
🇮🇹Conegliano, Italy
Department of Neurology, Santa Croce Hospital
🇮🇹Cuneo, Italy
Department of Neurology and Stroke Unit, Desio Hospital ASST Monza
🇮🇹Desio, Italy
Department of Neurology, ASUR Area Vasta 4 (ex ZT11)
🇮🇹Fermo, Italy
Department of Neurology, San Giovanni di Dio Hospital
🇮🇹Florence, Italy
Department of NeurologY, AOU of Ferrara
🇮🇹Ferrara, Italy
Stroke Unit, AOU Careggi
🇮🇹Florence, Italy
Department of Neurology, Ente Ospedali Galliera Genova
🇮🇹Genova, Italy
Department of Neurology, ASUGI
🇮🇹Gorizia, Italy
Department of Neurology, USL Toscana sud est
🇮🇹Grosseto, Italy
Stroke Unit, San Martino Hospital of Genova
🇮🇹Genova, Italy
Department of Neurology and Stroke Unit, ASUR Marche AV2 Jesi
🇮🇹Jesi, Italy
Departement of Neurology, San Salvatore Hospital
🇮🇹L'Aquila, Italy
Department of Neuology, Sant'Andrea Hospital, Azienda Sanitaria Locale n. 5 "Spezzino" La Spezia
🇮🇹La Spezia, Italy
Department of Neurology, F Renzetti Hospital
🇮🇹Lanciano, Italy
Department of Neurology, Ospedale Vito Fazi
🇮🇹Lecce, Italy
UTN, Santa Maria Goretti Hospital
🇮🇹Latina, Italy
Department of Neurology, Legnago Hospital
🇮🇹Legnago, Italy
Department of Neurology and Stroke Unit Ospedale of Legnano
🇮🇹Legnano, Italy
Department of Neurology, Valle del Serchio Hospital
🇮🇹Lucca, Italy
Emergency Department, Azienda USL 6 Livorno
🇮🇹Livorno, Italy
Department of Neurology, Apuane Hospital, Azienda USL Toscana Nord Ovest
🇮🇹Massa, Italy
Department of Neurology, ASST Melegnano e della Martesana
🇮🇹Melegnano, Italy
Department of Neurology, ASST Merate
🇮🇹Merate, Italy
Stroke Unit, AOU Gaetano Martino
🇮🇹Messina, Italy
Stroke Unit, Angelo's Hospital
🇮🇹Mestre, Italy
Department of Neurology and Stroke Unit, Humanitas
🇮🇹Milano, Italy
Department of Neurology and Stroke Unit, IRCCS Istituto Auxologico Italiano, San Luca Hospital
🇮🇹Milano, Italy
Stroke Unit, Istituto Clinico Città Studi
🇮🇹Milan, Italy
Department of Neurology, Mirano ULSS 3 Serenissima
🇮🇹Mirano, Italy
Stroke Unit, Santa Croce Hospital
🇮🇹Moncalieri, Italy
Stroke Unit, "S.Agostino-Estense" Hospital, AOU of Modena
🇮🇹Modena, Italy
Department of Neurology, San Gerardo Hospital and Bicocca University
🇮🇹Monza, Italy
Stroke Unit, Ospedale del Mare
🇮🇹Napoli, Italy
Department of Neurology and Stroke Unit, Cardarelli Hospital
🇮🇹Napoli, Italy
Department of Neurology and Stroke Unit, AOU Maggiore della Carità
🇮🇹Novara, Italy
Stroke Unit, San Giacomo Hospital
🇮🇹Novi Ligure, Italy
Stroke Unit, Azienda Ospedale Università
🇮🇹Padova, Italy
Stroke Unit, AOU San Luigi Gonzaga
🇮🇹Orbassano, Italy
Department of Neurology, Villa Sofia Hospital
🇮🇹Palermo, Italy
Department of Neurology and Stroke Unit, ARNAS Civico of Palermo
🇮🇹Palermo, Italy
Department of Neurophysiopathology and Stroke Unit, AOUP Paolo Giaccone
🇮🇹Palermo, Italy
Department of neurology, Azienda Ospedaliero-Universitario di Parma
🇮🇹Parma, Italy
Stroke Unit, Buccheri La Ferla Hospital
🇮🇹Palermo, Italy
Stroke Unit, Fidenza AUSL PR
🇮🇹Parma, Italy
Cerebrovascula disease and Stroke Unit neurological Intitute IRCCS Mondino
🇮🇹Pavia, Italy
Stroke Unit, AOUUD Santa Maria della Misericordia
🇮🇹Perugia, Italy
Department of Neurology ande Stroke Unit, Pescara Hospital
🇮🇹Pescara, Italy
Department of Neurology, AUSL Piacenza
🇮🇹Piacenza, Italy
Stroke Unit, Pederzoli Hospital
🇮🇹Peschiera Del Garda, Italy
Departement of Neurology and Stroke Center, S.Corona Hospital
🇮🇹Pietra Ligure, Italy
Department of Neurology and Stroke Unit, E. Agnelli Hospital
🇮🇹Pinerolo, Italy
Department of Neurology, San Jacopo Hospital
🇮🇹Pistoia, Italy
Stroke Unit, AO"San Carlo"
🇮🇹Potenza, Italy
Department of Neurology, Azienda ospedaliera e universitaria Pisana
🇮🇹Pisa, Italy
Department of Neurology, Maria Paternò Arezzo Hospital
🇮🇹Ragusa, Italy
Stroke Unit, AO "Bianchi-Melacrino-Morelli"
🇮🇹Reggio Calabria, Italy
Department of Neurology and Stroke Unit, Santa Maria delle Croci Hospital
🇮🇹Ravenna, Italy
Department of Neurology and Stroke Unit, Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Department of Neurology, Infermi di Rimini Hospital
🇮🇹Rimini, Italy
Department of Neurology and Stroke Unit, Sant'Eugenio Hospital
🇮🇹Rome, Italy
Unità di trattamento neurovascolare, Azienda Ospedaliero Universitaria Policlinico Umberto I
🇮🇹Roma, Italy
Department of Neurology and Stroke Unit, Systems Medicin, Policlinico Tor Vergata
🇮🇹Rome, Italy
Department of Neurology, Policlinico Gemelli
🇮🇹Rome, Italy
Department of Neurology, Ospedale Fatebenefratelli
🇮🇹Rome, Italy
Department of Neurology, SS Filippo Neri Hospital
🇮🇹Rome, Italy
Stroke Unit, AO San Camillo
🇮🇹Rome, Italy
Department of Neurology, Presidio ospedaliero Umberto I Nocera Inferiore
🇮🇹Salerno, Italy
Stroke Unit, AOU Sant'Andrea
🇮🇹Rome, Italy
Stroke Unit, Ospedale Rovigo, ULSS 18
🇮🇹Rovigo, Italy
Department of Neurology, Madonna del Soccorso Hospital
🇮🇹San Benedetto Del Tronto, Italy
Department of Neurology, ASST Lariana, Sant'Anna Hospital
🇮🇹San Fermo Della Battaglia, Italy
Stroke Unit, AOU
🇮🇹Sassari, Italy
Department of Neurology, Casa sollievo della sofferenza
🇮🇹San Giovanni Rotondo, Italy
Department of Neurology, SS. Annunziata Hospital
🇮🇹Savigliano, Italy
Stroke Unit, Azienda ospedaliera universitaria Senese
🇮🇹Siena, Italy
Department of Neurology and Stroke Unit, Umberto I Hospital
🇮🇹Siracusa, Italy
Department of Neurology, SS Annunziata Hospital
🇮🇹Sulmona, Italy
Department of Neurology and Stroke Unit, AO Santa Maria of Terni
🇮🇹Terni, Italy
Department of Neurology and Stroke Unit, San Giovanni Bosco Hospital
🇮🇹Torino, Italy
Department of Neurology and Stroke Unit, ASP of Trapani
🇮🇹Trapani, Italy
Neuro-vascular Unit, Maria Vittoria Hospital
🇮🇹Torino, Italy
Stroke Unit, Santa Chiara Hospital
🇮🇹Trento, Italy
Department of Neurology, Cà Foncello Hospital
🇮🇹Treviso, Italy
Department of Neurology, Azienda Ospedaliera-Universitaria Giuliano Isontina
🇮🇹Trieste, Italy
Department of Neurology and Rehabilitation, ASUR
🇮🇹Udine, Italy
Department of Neurology, SS Giovanni e Paolo Hospital, Aulss3 Serenissima Veneto
🇮🇹Venezia, Italy
Department of Neurology and Stroke Unit, ASST Settelaghi
🇮🇹Varese, Italy
Department of Neurology, Sant'Andrea Hospital
🇮🇹Vercelli, Italy
Department of Neurology and Stroke Unit, Arzignano Azienda ULSS 8 Berica
🇮🇹Vicenza, Italy
Department of Neurology and Stroke Unit, Guzzardi Hospital
🇮🇹Vittoria, Italy
Department of Neurology and Stroke Unit, San Bortolo Hospital
🇮🇹Vicenza, Italy
Stroke Unit, ASST Vimercate
🇮🇹Vimercate, Italy