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

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT05476081

Acronym / sponsor ID

READAPT / 03/2021

Conditions

Ischemic Stroke, TIA

Keywords

DAPT, Stroke, TIA, antiplatelet treatment

Study type

Observational

Recruitment status

Completed

Enrolment

2,239 participants (actual)

Lead sponsor

University of L'AquilaUniversity, hospital or other

Study start

3 Feb 2021 (actual)

Primary completion

3 Feb 2023 (actual)

Study completion

3 May 2023 (actual)

First posted

27 Jul 2022 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

90 Days

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Primary composite outcome

   Time frame: 90 days from DAPT start

   Death, stroke recurrence (ischemic or hemorrhagic)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
• Background: PubMed 23803136Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
• Background: PubMed 17931979Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. doi: 10.1016/S1474-4422(07)70250-8. Epub 2007 Oct 10.
• Background: PubMed 29766750Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.
• Background: PubMed 32668111Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA. N Engl J Med. 2020 Jul 16;383(3):207-217. doi: 10.1056/NEJMoa1916870.
• Derived from this study: PubMed 40773777De Santis F, Foschi M, Romoli M, Tassinari T, Saia V, Cenciarelli S, Bedetti C, Padiglioni C, Censori B, Puglisi V, Vinciguerra L, Guarino M, Barone V, Zedde ML, Grisendi I, Diomedi M, Bagnato MR, Petruzzellis M, Mezzapesa DM, Di Viesti P, Inchingolo V, Cappellari M, Zenorini M, Candelaresi P, Andreone V, Rinaldi G, Bavaro A, Cavallini A, Moraru S, Querzani P, Piscaglia MG, Terruso V, Mannino M, Scoditti U, Pezzini A, Frisullo G, Muscia F, Paciaroni M, Mosconi MG, Zini A, Leone R, Palmieri C, Cupini LM, Marcon M, Tassi R, Sanzaro E, Paci C, Viticchi G, Orsucci D, Falcou A, Beretta S, Tarletti R, Nencini P, Rota E, Sepe FN, Ferrandi D, Caputi L, Volpi G, La Spada S, Beccia M, Rinaldi C, Mastrangelo V, Di Blasio F, Invernizzi P, Pelliccioni G, De Angelis MV, Bonanni L, Ruzza G, Caggia EA, Russo M, Tonon A, Acciarri MC, Anticoli S, Roberti C, Manobianca G, Scaglione G, Pistoia F, Fortini A, De Boni A, Sanna A, Chiti A, Barbarini L, Caggiula M, Masato M, Del Sette M, Passarelli F, Bongioanni MR, Toni D, Ricci S, De Matteis E, Sacco S, Ornello R; READAPT Study Group. Characteristics and causes of recurrent ischemic events in minor ischemic stroke and TIA in the READAPT study. J Neurol Sci. 2025 Sep 15;476:123641. doi: 10.1016/j.jns.2025.123641. Epub 2025 Aug 5.
• Derived from this study: PubMed 40661752De Santis F, Ornello R, De Matteis E, D'Anna L, Romoli M, Tassinari T, Saia V, Cenciarelli S, Bedetti C, Padiglioni C, Censori B, Puglisi V, Vinciguerra L, Guarino M, Barone V, Zedde M, Grisendi I, Diomedi M, Bagnato MR, Petruzzellis M, Mezzapesa DM, Inchingolo V, Cappellari M, Zivelonghi C, Candelaresi P, Andreone V, Rinaldi G, Bavaro A, Cavallini A, Piscaglia MG, Terruso V, Mannino M, Pezzini A, Frisullo G, Muscia F, Paciaroni M, Mosconi MG, Zini A, Leone R, Palmieri C, Cupini LM, Marcon M, Tassi R, Sanzaro E, Papiri G, Viticchi G, Orsucci D, Falcou A, Beretta S, Tarletti R, Nencini P, Rota E, Sepe FN, Ferrandi D, Caputi L, Volpi G, La Spada S, Beccia M, Rinaldi C, Mastrangelo V, Di Blasio F, Invernizzi P, Pelliccioni G, De Angelis MV, Bonanni L, Ruzza G, Caggia EA, Russo M, Tonon A, Acciarri MC, Anticoli S, Roberti C, Scaglione G, Pistoia F, Fortini A, De Boni A, Sanna A, Chiti A, Barbarini L, Caggiula M, Masato M, Del Sette M, Passarelli F, Bongioanni MR, De Michele M, Ricci S, Sacco S, Foschi M. Real-world outcomes following dual antiplatelet therapy in mild-to-moderate ischemic stroke with anterior versus posterior circulation infarct: a READAPT study propensity matched analysis. Ther Adv Neurol Disord. 2025 Jul 12;18:17562864251351100. doi: 10.1177/17562864251351100. eCollection 2025.
• Derived from this study: PubMed 40265654De Matteis E, De Santis F, Foschi M, Romoli M, Tassinari T, Saia V, Cenciarelli S, Bedetti C, Padiglioni C, Censori B, Puglisi V, Vinciguerra L, Guarino M, Barone V, Zedde M, Grisendi I, Maestrini I, Bagnato MR, Petruzzellis M, Mezzapesa DM, Di Viesti P, Inchingolo V, Cappellari M, Zenorini M, Candelaresi P, Andreone V, Rinaldi G, Bavaro A, Cavallini A, Moraru S, Piscaglia MG, Terruso V, Mannino M, Pezzini A, Frisullo G, Muscia F, Paciaroni M, Mosconi MG, Zini A, Leone R, Palmieri C, Cupini LM, Marcon M, Tassi R, Sanzaro E, Paci C, Viticchi G, Orsucci D, Falcou A, Diamanti S, Tarletti R, Nencini P, Rota E, Sepe FN, Ferrandi D, Caputi L, Volpi G, La Spada S, Beccia M, Rinaldi C, Mastrangelo V, Di Blasio F, Invernizzi P, Pelliccioni G, De Angelis MV, Bonanni L, Ruzza G, Caggia EA, Russo M, Tonon A, Acciarri MC, Anticoli S, Roberti C, Manobianca G, Scaglione G, Pistoia F, Fortini A, De Boni A, Sanna A, Chiti A, Barbarini L, Caggiula M, Masato M, Del Sette M, Passarelli F, Bongioanni MR, Toni D, Ricci S, Sacco S, Ornello R; READAPT Study Group. Real-World Dual Antiplatelet Therapy Use Exceeds Randomized Trials Boundaries With Possible Safety Issues in Patients With Large Artery Atherosclerosis-Insights From the READAPT Study. Eur J Neurol. 2025 Apr;32(4):e70163. doi: 10.1111/ene.70163.
• Derived from this study: PubMed 39648888Foschi M, D'Anna L, De Matteis E, De Santis F, Romoli M, Tassinari T, Saia V, Cenciarelli S, Bedetti C, Padiglioni C, Censori B, Puglisi V, Vinciguerra L, Guarino M, Barone V, Zedde M, Grisendi I, Diomedi M, Bagnato MR, Petruzzellis M, Mezzapesa DM, Di Viesti P, Inchingolo V, Cappellari M, Zivelonghi C, Candelaresi P, Andreone V, Rinaldi G, Bavaro A, Cavallini A, Moraru S, Piscaglia MG, Terruso V, Mannino M, Pezzini A, Frisullo G, Muscia F, Paciaroni M, Mosconi MG, Zini A, Leone R, Palmieri C, Cupini LM, Marcon M, Tassi R, Sanzaro E, Papiri G, Paci C, Viticchi G, Orsucci D, Falcou A, Beretta S, Tarletti R, Nencini P, Rota E, Sepe FN, Ferrandi D, Caputi L, Volpi G, La Spada S, Beccia M, Rinaldi C, Mastrangelo V, Di Blasio F, Invernizzi P, Pelliccioni G, De Angelis MV, Bonanni L, Ruzza G, Caggia EA, Russo M, Tonon A, Acciarri MC, Anticoli S, Roberti C, Manobianca G, Scaglione G, Pistoia F, Fortini A, De Boni A, Sanna A, Chiti A, Barbarini L, Caggiula M, Masato M, Del Sette M, Passarelli F, Bongioanni MR, De Michele M, Ricci S, Ornello R, Sacco S; READAPT Study Group. Exploring Sex Differences in Outcomes of Dual Antiplatelet Therapy for Patients With Noncardioembolic Mild-to-Moderate Ischemic Stroke or High-Risk Transient Ischemic Attack: A Propensity-Matched Analysis of the READAPT Study Cohort. Stroke. 2025 Feb;56(2):305-317. doi: 10.1161/STROKEAHA.124.049210. Epub 2024 Dec 9.
• Derived from this study: PubMed 39558660Ornello R, Foschi M, De Santis F, Romoli M, Tassinari T, Saia V, Cenciarelli S, Bedetti C, Padiglioni C, Censori B, Puglisi V, Vinciguerra L, Guarino M, Barone V, Zedde ML, Grisendi I, Diomedi M, Bagnato MR, Petruzzellis M, Mezzapesa DM, Di Viesti P, Inchingolo V, Cappellari M, Zenorini M, Candelaresi P, Andreone V, Rinaldi G, Bavaro A, Cavallini A, Moraru S, Querzani P, Terruso V, Mannino M, Scoditti U, Pezzini A, Frisullo G, Muscia F, Paciaroni M, Mosconi MG, Zini A, Leone R, Palmieri C, Cupini LM, Marcon M, Tassi R, Sanzaro E, Paci C, Viticchi G, Orsucci D, Falcou A, Diamanti S, Tarletti R, Nencini P, Rota E, Sepe FN, Ferrandi D, Caputi L, Volpi G, La Spada S, Beccia M, Rinaldi C, Mastrangelo V, Di Blasio F, Invernizzi P, Pelliccioni G, De Angelis MV, Bonanni L, Ruzza G, Caggia EA, Russo M, Tonon A, Acciarri MC, Anticoli S, Roberti C, Manobianca G, Scaglione G, Pistoia F, Fortini A, De Boni A, Sanna A, Chiti A, Barbarini L, Masato M, Del Sette M, Passarelli F, Bongioanni MR, Toni D, Ricci S, Sacco S, De Matteis E. Transient brain ischemic symptoms and the presence of ischemic lesions at neuroimaging: Results from the READAPT study. Int J Stroke. 2025 Apr;20(4):426-437. doi: 10.1177/17474930241302691. Epub 2024 Dec 16.
• Derived from this study: PubMed 39555606Foschi M, Ornello R, D'Anna L, De Matteis E, De Santis F, Barone V, Viola M, Mosconi MG, Rosin D, Romoli M, Tassinari T, Cenciarelli S, Censori B, Zedde M, Diomedi M, Petruzzellis M, Inchingolo V, Cappellari M, Candelaresi P, Bavaro A, Cavallini A, Piscaglia MG, Terruso V, Pezzini A, Frisullo G, Muscia F, Zini A, Leone R, Palmieri C, Cupini LM, Marcon M, Tassi R, Sanzaro E, Papiri G, Viticchi G, Orsucci D, Falcou A, Diamanti S, Tarletti R, Nencini P, Rota E, Sepe FN, Caputi L, Volpi G, La Spada S, Beccia M, Mastrangelo V, Invernizzi P, Pelliccioni G, De Angelis MV, Bonanni L, Ruzza G, Caggia EA, Russo M, Tonon A, Acciarri MC, Anticoli S, Roberti C, Scaglione G, Pistoia F, Alessi C, De Boni A, Sanna A, Chiti A, Barbarini L, Masato M, Del Sette M, Passarelli F, Bongioanni MR, De Michele M, Ricci S, Valente M, Gigli GL, Merlino G, Paciaroni M, Guarino M, Sacco S. Real-world comparison of dual versus single antiplatelet treatment in patients with non-cardioembolic mild-to-moderate ischemic stroke: A propensity matched analysis. Int J Stroke. 2025 Apr;20(4):438-449. doi: 10.1177/17474930241302991. Epub 2024 Dec 16.
• Derived from this study: PubMed 39244893Foschi M, De Matteis E, De Santis F, Romoli M, Tassinari T, Saia V, Cenciarelli S, Bedetti C, Padiglioni C, Censori B, Puglisi V, Vinciguerra L, Guarino M, Barone V, Zedde M, Grisendi I, Diomedi M, Bagnato MR, Petruzzellis M, Mezzapesa DM, Di Viesti P, Inchingolo V, Cappellari M, Zivelonghi C, Candelaresi P, Andreone V, Rinaldi G, Bavaro A, Cavallini A, Moraru S, Querzani P, Terruso V, Mannino M, Pezzini A, Frisullo G, Muscia F, Paciaroni M, Mosconi MG, Zini A, Leone R, Palmieri C, Cupini LM, Marcon M, Tassi R, Sanzaro E, Paci C, Viticchi G, Orsucci D, Falcou A, Diamanti S, Tarletti R, Nencini P, Rota E, Sepe FN, Ferrandi D, Caputi L, Volpi G, La Spada S, Beccia M, Rinaldi C, Mastrangelo V, Di Blasio F, Invernizzi P, Pelliccioni G, De Angelis MV, Bonanni L, Ruzza G, Caggia EA, Russo M, Tonon A, Acciarri MC, Anticoli S, Roberti C, Manobianca G, Scaglione G, Pistoia F, Fortini A, De Boni A, Sanna A, Chiti A, Barbarini L, Caggiula M, Masato M, Del Sette M, Passarelli F, Bongioanni MR, Toni D, Ricci S, Sacco S, Ornello R. Defining short-term outcomes of minor ischemic stroke due to small artery occlusion in the era of dual antiplatelet treatment: A READAPT study sub-analysis. J Neurol Sci. 2024 Nov 15;466:123211. doi: 10.1016/j.jns.2024.123211. Epub 2024 Sep 2.
• Derived from this study: PubMed 39119964Ornello R, Foschi M, De Santis F, Romoli M, Tassinari T, Saia V, Cenciarelli S, Bedetti C, Padiglioni C, Censori B, Puglisi V, Vinciguerra L, Guarino M, Barone V, Zedde M, Grisendi I, Diomedi M, Bagnato MR, Petruzzellis M, Mezzapesa DM, Di Viesti P, Inchingolo V, Cappellari M, Zivelonghi C, Candelaresi P, Andreone V, Rinaldi G, Bavaro A, Cavallini A, Moraru S, Querzani P, Terruso V, Mannino M, Pezzini A, Frisullo G, Muscia F, Paciaroni M, Mosconi MG, Zini A, Leone R, Palmieri C, Cupini LM, Marcon M, Tassi R, Sanzaro E, Paci C, Viticchi G, Orsucci D, Falcou A, Beretta S, Tarletti R, Nencini P, Rota E, Sepe FN, Ferrandi D, Caputi L, Volpi G, La Spada S, Beccia M, Rinaldi C, Mastrangelo V, Di Blasio F, Invernizzi P, Pelliccioni G, De Angelis MV, Bonanni L, Ruzza G, Caggia EA, Russo M, Tonon A, Acciarri MC, Anticoli S, Roberti C, Manobianca G, Scaglione G, Pistoia F, Fortini A, De Boni A, Sanna A, Chiti A, Barbarini L, Caggiula M, Masato M, Del Sette M, Passarelli F, Bongioanni MR, Toni D, Ricci S, De Matteis E, Sacco S; READAPT Study Group. Combining Intravenous Thrombolysis and Dual Antiplatelet Treatment in Patients With Minor Ischemic Stroke: A Propensity Matched Analysis of the READAPT Study Cohort. J Am Heart Assoc. 2024 Aug 20;13(16):e036275. doi: 10.1161/JAHA.124.036275. Epub 2024 Aug 9.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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