ASPirin for Acute Pneumonia in the elderlY (ASPAPY): protocol of a multicentre randomised double-blind placebo-controlled trial
Introduction Acute pneumonia (AP) remains a leading cause of death in the older population. Excess risk of death after AP is partly due to cardiovascular (CV) events. We aim to evaluate whether aspirin at a preventive dose (100 mg daily) introduced at the acute phase of AP reduces 90-day mortality.M...
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BMJ Publishing Group
2025-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/5/e102768.full |
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| author | Sylvain Diamantis Lionel Piroth Gaetan Gavazzi Isabelle Fournel Caroline Laborde Eléa Ksiazek Amelie Cransac Guillaume Deschasse Alain Putot Patrick Manckoundia Marion Cortier Mortada Adjim Amal Aidoud Thomas Brunet Tomasz Chroboczek Michele Collart Matthieu Coulongeat Sarah Lelarge Nadège Lemarie Claire Roubaud-Baudron |
| author_facet | Sylvain Diamantis Lionel Piroth Gaetan Gavazzi Isabelle Fournel Caroline Laborde Eléa Ksiazek Amelie Cransac Guillaume Deschasse Alain Putot Patrick Manckoundia Marion Cortier Mortada Adjim Amal Aidoud Thomas Brunet Tomasz Chroboczek Michele Collart Matthieu Coulongeat Sarah Lelarge Nadège Lemarie Claire Roubaud-Baudron |
| collection | DOAJ |
| description | Introduction Acute pneumonia (AP) remains a leading cause of death in the older population. Excess risk of death after AP is partly due to cardiovascular (CV) events. We aim to evaluate whether aspirin at a preventive dose (100 mg daily) introduced at the acute phase of AP reduces 90-day mortality.Methods and analysis The ASPirin for Acute Pneumonia in the elderlY study is a phase III multicentre randomised double-blind, placebo-controlled, superiority clinical trial, which will investigate the efficacy and safety of aspirin in older patients with AP hospitalised in a French university and non-university hospitals. Patients will be randomised in a 1:1 ratio between two groups receiving daily either 100 mg of aspirin or a placebo, within 84 hours following radiologically proven AP diagnosis for 90 days. This study aimed at assessing the efficacy of aspirin on all-cause mortality after AP at 90 days (D90) (primary objective), D30 and D120 after randomisation, CV mortality, major adverse CV events (MACE) (ie, myocardial infarction, stroke, heart failure, new atrial fibrillation and pulmonary embolism, CV death and sudden death) incidence, length of intensive care unit and hospital stay, unscheduled rehospitalisation, dependence, overall and MACE-free survival, as well as safety outcomes (bleeding incidence). The sample size, calculated considering a 90-day mortality of 25% and a reduction of 10% in the aspirin group, a two-sided alpha risk at 5% and power of 80%, is 500 patients to prove the superiority of aspirin over placebo. To account for screening failures and consent withdrawals, 600 patients (300 per arm) will be included.Ethics and dissemination This study has full approval from an independent Ethics Committee. Participants will sign a written informed consent ahead of participation. Findings will be published in peer-reviewed journals and conference presentations.Trial registration number EU CTIS: 2024-510811-32-00. |
| format | Article |
| id | doaj-art-9a6e01b520504baa9faf4b558b894fd2 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-05-01 |
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| spelling | doaj-art-9a6e01b520504baa9faf4b558b894fd22025-08-20T02:16:22ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2025-102768ASPirin for Acute Pneumonia in the elderlY (ASPAPY): protocol of a multicentre randomised double-blind placebo-controlled trial 0Sylvain DiamantisLionel PirothGaetan GavazziIsabelle Fournel1Caroline LabordeEléa Ksiazek2Amelie Cransac3Guillaume DeschasseAlain Putot4Patrick Manckoundia5Marion Cortier6Mortada AdjimAmal AidoudThomas BrunetTomasz ChroboczekMichele CollartMatthieu CoulongeatSarah LelargeNadège LemarieClaire Roubaud-Baudron1Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, New York, USAClinical Epidemiology, Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, FranceClinical Epidemiology, Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, FrancePharmacy, Centre Hospitalier Universitaire de Dijon, Dijon, FranceInfectious Disease and Internal Medicine Department, Hôpitaux du Pays du Mont-Blanc, Sallanches, FranceGeriatric Internal Medicine Department, Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, FranceDirection of Clinical Research and Innovation, Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, FranceIntroduction Acute pneumonia (AP) remains a leading cause of death in the older population. Excess risk of death after AP is partly due to cardiovascular (CV) events. We aim to evaluate whether aspirin at a preventive dose (100 mg daily) introduced at the acute phase of AP reduces 90-day mortality.Methods and analysis The ASPirin for Acute Pneumonia in the elderlY study is a phase III multicentre randomised double-blind, placebo-controlled, superiority clinical trial, which will investigate the efficacy and safety of aspirin in older patients with AP hospitalised in a French university and non-university hospitals. Patients will be randomised in a 1:1 ratio between two groups receiving daily either 100 mg of aspirin or a placebo, within 84 hours following radiologically proven AP diagnosis for 90 days. This study aimed at assessing the efficacy of aspirin on all-cause mortality after AP at 90 days (D90) (primary objective), D30 and D120 after randomisation, CV mortality, major adverse CV events (MACE) (ie, myocardial infarction, stroke, heart failure, new atrial fibrillation and pulmonary embolism, CV death and sudden death) incidence, length of intensive care unit and hospital stay, unscheduled rehospitalisation, dependence, overall and MACE-free survival, as well as safety outcomes (bleeding incidence). The sample size, calculated considering a 90-day mortality of 25% and a reduction of 10% in the aspirin group, a two-sided alpha risk at 5% and power of 80%, is 500 patients to prove the superiority of aspirin over placebo. To account for screening failures and consent withdrawals, 600 patients (300 per arm) will be included.Ethics and dissemination This study has full approval from an independent Ethics Committee. Participants will sign a written informed consent ahead of participation. Findings will be published in peer-reviewed journals and conference presentations.Trial registration number EU CTIS: 2024-510811-32-00.https://bmjopen.bmj.com/content/15/5/e102768.full |
| spellingShingle | Sylvain Diamantis Lionel Piroth Gaetan Gavazzi Isabelle Fournel Caroline Laborde Eléa Ksiazek Amelie Cransac Guillaume Deschasse Alain Putot Patrick Manckoundia Marion Cortier Mortada Adjim Amal Aidoud Thomas Brunet Tomasz Chroboczek Michele Collart Matthieu Coulongeat Sarah Lelarge Nadège Lemarie Claire Roubaud-Baudron ASPirin for Acute Pneumonia in the elderlY (ASPAPY): protocol of a multicentre randomised double-blind placebo-controlled trial BMJ Open |
| title | ASPirin for Acute Pneumonia in the elderlY (ASPAPY): protocol of a multicentre randomised double-blind placebo-controlled trial |
| title_full | ASPirin for Acute Pneumonia in the elderlY (ASPAPY): protocol of a multicentre randomised double-blind placebo-controlled trial |
| title_fullStr | ASPirin for Acute Pneumonia in the elderlY (ASPAPY): protocol of a multicentre randomised double-blind placebo-controlled trial |
| title_full_unstemmed | ASPirin for Acute Pneumonia in the elderlY (ASPAPY): protocol of a multicentre randomised double-blind placebo-controlled trial |
| title_short | ASPirin for Acute Pneumonia in the elderlY (ASPAPY): protocol of a multicentre randomised double-blind placebo-controlled trial |
| title_sort | aspirin for acute pneumonia in the elderly aspapy protocol of a multicentre randomised double blind placebo controlled trial |
| url | https://bmjopen.bmj.com/content/15/5/e102768.full |
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