A REAl-life Study on Short-term DAPT in Patients With Ischemic Stroke or TIA (READAPT)

July 29, 2022 updated by: Simona Sacco, University of L'Aquila

A REAl-life Study on Short-term Dual Antiplatelet Treatment in Patients With Ischemic Stroke or Transient Ischemic Attack

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1067

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Acquaviva Delle Fonti, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit, Ente Ecclesiastico ospedale Generale Regionale Miulli
        • Contact:
      • Alessandria, Italy
        • Recruiting
        • Department f Neurology, AO Nazionale SS Biagio and Cesare Arrigo
        • Contact:
      • Altamura, Italy
        • Not yet recruiting
        • Department of Neurology, Murgia Hospital Fabio Perinei SS 96
        • Contact:
          • Ardito Bonaventura, MD
      • Ancona, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit Ospedali Riuniti Ancona
        • Contact:
      • Ancona, Italy
        • Recruiting
        • Department of Neurology, INRCA-IRCCS "U Sestili" Hospital
        • Contact:
      • Aosta, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, "U. Parini" Hospital
        • Contact:
      • Arezzo, Italy
        • Not yet recruiting
        • Department of Neurology, San Donato Hospital, Azienda USL Toscana Sud Est, Arezzo e Val D'Arno
        • Contact:
      • Bari, Italy
      • Bari, Italy
        • Recruiting
        • Stroke Unit, Policlinico di Bari, Giovanni XXIII Hospital
        • Contact:
      • Barletta, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, "Mons. Dimiccoli" Hospital
        • Contact:
      • Bassano Del Grappa, Italy
      • Belluno, Italy
      • Benevento, Italy
      • Bologna, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit, Maggiore Hospital, IRCCS Istituto delle Scienze Neurologiche di Bologna
        • Contact:
        • Contact:
      • Bologna, Italy
        • Not yet recruiting
        • Department of Neurology, Policlinico S. Orsola-Malpighi-Clinica Neurologica Metropolitana, IRCCS Istituto delle Scienze Neurologiche di Bologna
        • Contact:
      • Branca, Italy
      • Brescia, Italy
        • Not yet recruiting
        • Neuro-vascular Unit, AO Spedali Civili
        • Contact:
      • Brescia, Italy
      • Brescia, Italy
      • Brindisi, Italy
      • Cagliari, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, AO "G. Brotzu"
        • Contact:
      • Caltanissetta, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, S Elia Hospital
        • Contact:
      • Caserta, Italy
        • Not yet recruiting
        • Stroke Unit, AO San Sebastiano AORN Caserta
        • Contact:
      • Castelfranco Veneto, Italy
      • Catania, Italy
      • Cefalù, Italy
        • Not yet recruiting
        • Department of Neurology, Institute G. Giglio di Cefalù
        • Contact:
      • Cesena, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit, "Bufalini" Hospital
        • Contact:
          • Michele Romoli, MD
      • Chieti, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit, SS Annunziata Hospital
        • Contact:
      • Cittadella, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, Cittadella, AULSS6 Euganea
        • Contact:
          • Giampietro Ruzza, MD
      • Città di Castello, Italy
      • Como, Italy
        • Not yet recruiting
        • Stroke Unit, Valduce Hospital
        • Contact:
      • Conegliano, Italy
        • Not yet recruiting
        • Department of Neurology, Conegliano Hospital Aulss 2 Veneto
        • Contact:
          • Anna Gaudenzi, MD
      • Crema, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit, ASST Maggiore Hospital of Crema
        • Contact:
      • Cremona, Italy
        • Recruiting
        • Department of Neurology, ASST Cremona
        • Contact:
      • Cuneo, Italy
        • Not yet recruiting
        • Department of Neurology, Santa Croce Hospital
        • Contact:
      • Desio, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, Desio Hospital ASST Monza
        • Contact:
      • Fermo, Italy
      • Ferrara, Italy
        • Not yet recruiting
        • Department of NeurologY, AOU of Ferrara
        • Contact:
      • Florence, Italy
      • Florence, Italy
      • Genova, Italy
      • Genova, Italy
      • Gorizia, Italy
      • Grosseto, Italy
      • Jesi, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, ASUR Marche AV2 Jesi
        • Contact:
      • L'Aquila, Italy
      • La Spezia, Italy
        • Not yet recruiting
        • Department of Neuology, Sant'Andrea Hospital, Azienda Sanitaria Locale n. 5 "Spezzino" La Spezia
        • Contact:
      • Lanciano, Italy
      • Latina, Italy
      • Lecce, Italy
        • Not yet recruiting
        • Department of Neurology, Ospedale Vito Fazi
        • Contact:
          • Leonardo Barberini, MD
      • Legnago, Italy
        • Not yet recruiting
        • Department of Neurology, Legnago Hospital
        • Contact:
      • Legnano, Italy
      • Livorno, Italy
      • Lucca, Italy
        • Not yet recruiting
        • Department of Neurology, Valle del Serchio Hospital
        • Contact:
          • Daniele Orsucci, MD
      • Massa, Italy
      • Melegnano, Italy
      • Merate, Italy
      • Messina, Italy
        • Not yet recruiting
        • Stroke Unit, AOU Gaetano Martino
        • Contact:
      • Mestre, Italy
        • Recruiting
        • Stroke Unit, Angelo's Hospital
        • Contact:
      • Milan, Italy
      • Milano, Italy
      • Milano, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, IRCCS Istituto Auxologico Italiano, San Luca Hospital
        • Contact:
      • Mirano, Italy
        • Recruiting
        • Department of Neurology, Mirano ULSS 3 Serenissima
        • Contact:
          • Maela Masato, MD
      • Modena, Italy
        • Not yet recruiting
        • Stroke Unit, "S.Agostino-Estense" Hospital, AOU of Modena
        • Contact:
      • Moncalieri, Italy
      • Monza, Italy
      • Napoli, Italy
      • Napoli, Italy
      • Novara, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit, AOU Maggiore della Carità
        • Contact:
      • Novi Ligure, Italy
      • Orbassano, Italy
      • Padova, Italy
      • Palermo, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, ARNAS Civico of Palermo
        • Contact:
      • Palermo, Italy
        • Not yet recruiting
        • Department of Neurology, Villa Sofia Hospital
        • Contact:
      • Palermo, Italy
        • Not yet recruiting
        • Department of Neurophysiopathology and Stroke Unit, AOUP Paolo Giaccone
        • Contact:
      • Palermo, Italy
        • Not yet recruiting
        • Stroke Unit, Buccheri La Ferla Hospital
        • Contact:
          • Aurelio Piazza, MD
      • Parma, Italy
        • Recruiting
        • Department of neurology, Azienda Ospedaliero-Universitario di Parma
        • Contact:
      • Parma, Italy
        • Not yet recruiting
        • Stroke Unit, Fidenza AUSL PR
        • Contact:
      • Pavia, Italy
        • Recruiting
        • Cerebrovascula disease and Stroke Unit neurological Intitute IRCCS Mondino
        • Contact:
      • Perugia, Italy
      • Pescara, Italy
        • Not yet recruiting
        • Department of Neurology ande Stroke Unit, Pescara Hospital
        • Contact:
      • Peschiera Del Garda, Italy
      • Piacenza, Italy
        • Not yet recruiting
        • Department of Neurology, AUSL Piacenza
        • Contact:
      • Pietra Ligure, Italy
      • Pinerolo, Italy
      • Pisa, Italy
        • Not yet recruiting
        • Department of Neurology, Azienda ospedaliera e universitaria Pisana
        • Contact:
      • Pistoia, Italy
      • Potenza, Italy
        • Not yet recruiting
        • Stroke Unit, AO"San Carlo"
        • Contact:
      • Ragusa, Italy
        • Recruiting
        • Department of Neurology, Maria Paternò Arezzo Hospital
        • Contact:
      • Ravenna, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, Santa Maria delle Croci Hospital
        • Contact:
      • Reggio Calabria, Italy
        • Not yet recruiting
        • Stroke Unit, AO "Bianchi-Melacrino-Morelli"
        • Contact:
      • Reggio Emilia, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, Arcispedale Santa Maria Nuova
        • Contact:
      • Rimini, Italy
      • Roma, Italy
        • Not yet recruiting
        • Unità di trattamento neurovascolare, Azienda Ospedaliero Universitaria Policlinico Umberto I
        • Contact:
      • Rome, Italy
      • Rome, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit, Systems Medicin, Policlinico Tor Vergata
        • Contact:
      • Rome, Italy
      • Rome, Italy
      • Rome, Italy
      • Rome, Italy
      • Rome, Italy
      • Rovigo, Italy
      • Salerno, Italy
        • Not yet recruiting
        • Department of Neurology, Presidio ospedaliero Umberto I Nocera Inferiore
        • Contact:
      • San Benedetto Del Tronto, Italy
      • San Fermo Della Battaglia, Italy
      • San Giovanni Rotondo, Italy
        • Recruiting
        • Department of Neurology, Casa sollievo della sofferenza
        • Contact:
      • Sassari, Italy
      • Savigliano, Italy
      • Siena, Italy
        • Recruiting
        • Stroke Unit, Azienda ospedaliera universitaria Senese
        • Contact:
      • Siracusa, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit, Umberto I Hospital
        • Contact:
      • Sulmona, Italy
        • Not yet recruiting
        • Department of Neurology, SS Annunziata Hospital
        • Contact:
      • Terni, Italy
        • Recruiting
        • Department of Neurology and Stroke Unit, AO Santa Maria of Terni
        • Contact:
      • Torino, Italy
      • Torino, Italy
      • Trapani, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, ASP of Trapani
        • Contact:
      • Trento, Italy
      • Treviso, Italy
        • Not yet recruiting
        • Department of Neurology, Cà Foncello Hospital
        • Contact:
      • Trieste, Italy
        • Not yet recruiting
        • Department of Neurology, Azienda Ospedaliera-Universitaria Giuliano Isontina
        • Contact:
      • Udine, Italy
        • Not yet recruiting
        • Department of Neurology and Rehabilitation, ASUR
        • Contact:
          • Francesco Janes, MD
      • Varese, Italy
      • Venezia, Italy
        • Recruiting
        • Department of Neurology, SS Giovanni e Paolo Hospital, Aulss3 Serenissima Veneto
        • Contact:
      • Vercelli, Italy
      • Vicenza, Italy
      • Vicenza, Italy
      • Vimercate, Italy
      • Vittoria, Italy
        • Not yet recruiting
        • Department of Neurology and Stroke Unit, Guzzardi Hospital
        • Contact:
    • Abruzzo
      • Avezzano, Abruzzo, Italy, 67051
        • Recruiting
        • Neurology e Stroke Unit Departement, SS Filippo e Nicola Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Eleonora De Matteis, MD
        • Sub-Investigator:
          • Federico De Santis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients (single cohort study)
Patients presenting with a mild-to-moderate ischemic stroke or high risk TIA
Drug: Aspirin
Aspirin (100-300 mg) administered for 21-90 days in combination with another antiplatelet treatment
Other Names:
  • acetylsalicylic acid
  • B01AC06
Drug: Clopidogrel
Clopidogrel (75-600 mg) administered for 21-90 days in combination with another antiplatelet treatment
Other Names:
  • B01AC04
Drug: Ticagrelor
Ticagrelor (90-180 mg) administered for 21-90 days in combination with another antiplatelet treatment
Other Names:
  • B01AC24

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary composite outcome
Time Frame: 90 days from DAPT start
Death, stroke recurrence (ischemic or hemorrhagic)
90 days from DAPT start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic stroke
Time Frame: 90 days from DAPT start
90 days from DAPT start
TIA
Time Frame: 90 days from DAPT start
90 days from DAPT start
Intracerebral hemorrhage (ICH)
Time Frame: 90 days from DAPT start
Lobar or non lobar ICH
90 days from DAPT start
Subarachnoid hemorrhage
Time Frame: 90 days from DAPT start
90 days from DAPT start
Other intracranial hemorrhage
Time Frame: 90 days from DAPT start
Subdural or epidural hematoma
90 days from DAPT start
Mild bleeding
Time Frame: 90 days from DAPT start
bleeding not requiring blood transfusion or causing hemodynamic compromise
90 days from DAPT start
Moderate bleeding
Time Frame: 90 days from DAPT start
bleeding requiring blood transfusion, but not causing hemodynamic compromise
90 days from DAPT start
Severe bleeding
Time Frame: 90 days from DAPT start
bleeding causing hemodynamic compromise and requiring blood transfusion, inotropic support, or surgical intervention and
90 days from DAPT start
Myocardial infarction
Time Frame: 90 days from DAPT start
90 days from DAPT start
Hospitalization
Time Frame: 90 days from DAPT start
hospitalization due to any cause
90 days from DAPT start
Death due to vascular causes
Time Frame: 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.
90 days from DAPT start
Death due to non-vascular causes
Time Frame: 90 days from DAPT start
Death due all the other causes (i.e. infections, neoplasms etc)
90 days from DAPT start

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRs)
Time Frame: 90 days from DAPT start
measure of the disability through a scale from 1 to 6, where 6 indicated death
90 days from DAPT start
Early DAPT discontinuation
Time Frame: 90 days from DAPT start
Treatment discontinuation due to adverse events, lack of compliance or Diagnosis of atrial fibrillation or other condition requiring anticoagulant treatment
90 days from DAPT start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Investigators

  • Study Chair: Simona Sacco, MD, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2021

Primary Completion (Anticipated)

February 3, 2023

Study Completion (Anticipated)

May 3, 2023

Study Registration Dates

First Submitted

July 24, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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