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Not yet recruitingNCT06774846ASPAPYUpdated Sep 24, 2026

Aspirin in Acute Pneumonia in the Elderly: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial.

A Phase 3 interventional study of Acetylsalicylic acid/Aspirin (100 mg) and Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride in Acute Pneumonia and Elderly Person, sponsored by Centre Hospitalier Universitaire Dijon. Not yet recruiting. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Centre Hospitalier Universitaire Dijon · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study summary

Acute pneumonia is a very common disease, and one of the leading causes of hospitalization and death in France. Almost a century after the discovery of penicillin, no major breakthrough has significantly reduced pneumonia-related mortality. While the choice of an appropriate antibiotic is decisive in the acute phase of the disease, the longer-term prognosis depends essentially on the worsening of other underlying pathologies, particularly in the elderly. In cured patients, excess mortality persists several months after the episode of pneumonia, due in particular to the onset of cardiovascular complications. Recent scientific literature shows an association between the prescription of cardio-protective drugs and survival after pneumonia. Older patients are usually excluded from interventional studies, so there are no specific recommendations for these patients at high risk of both acute pneumonia and cardiovascular events.

The aim of this study is to assess the efficacy of low-dose aspirin therapy after pneumonia in preventing cardiovascular events in the elderly.

The main objective is therefore to evaluate the impact of aspirin at a dose of 100mg per day on all-cause mortality at 90 days in patients over 75 years of age hospitalized for pneumonia.

02

Conditions studied

  • Acute Pneumonia
  • Elderly Person

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03

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's planned enrollment of 600 is above the median of 129 across 975 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • obtained from patient or relative/trusted person if patient unable to consent
  • Age ≥75 years
  • Clinical diagnosis of AP, presumed to be of bacterial or viral origin, with at least two of the following signs or symptoms:
  • cough,
  • purulent expectoration,
  • thoracic pain,
  • dyspnea/tachypnea,
  • temperature > 37.8°C or \< 36°C,
  • unilateral crackles
  • Patient hospitalized for at least 48 hours
  • Onset of clinical signs \< 7 days
  • New radiological infiltrate documented by X-ray, ultrasound or CT scan

Exclusion criteria

Exclusion Criteria:

  • Mechanically ventilated pneumonia
  • Documented SARS CoV2 pneumonia
  • Patient with at least 3 episodes of inhalation pneumonitis in the 12 months prior to inclusion
  • Pre-acute episode swallowing disorders impairing oral medication intake
  • Physician-assessed \< 90 days
  • Anticoagulant treatment (curative doses)
  • Antiplatelet therapy
  • Steroidal or non-steroidal anti-inflammatory treatment or oral without proton pump inhibitor (PPI)
  • Treatment with methotrexate (>20 mg per week), anagrelide, probenecid, nicorandil, defibrotide
  • Dyspepsia or gastroesophageal reflux disease (GERD) without PPI use
  • to aspirin (preventive doses) or its placebo at the time of inclusion:
  • to acetylsalicylic acid or to any of the of the drug or placebo
  • History of asthma induced by the administration of salicylates or non-steroidal anti-inflammatory drugs
  • Active peptic ulcer disease or history of recurrent peptic ulcer disease
  • History of cerebrovascular haemorrhage
  • Previous gastrointestinal hemorrhage
  • History of hemorrhage with > 3g /dl requiring transfusion, vasoactive treatment or surgery
  • Known hereditary or acquired coagulation disorder
  • Thrombocytopenia ( \< 50 giga/L)
  • Acute kidney injury (clairance \< 15 ml/min selon - Modification of Diet in Renal Disease),
  • Liver cirrhosis or acute liver failure (\<50%),
  • Severe uncontrolled heart failure
  • Persistente severe hypertension (PAS > 180mmHg)
  • Patient with mastocytosis
  • Person not affiliated to a national social security scheme
  • Patient under court protection
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Experimental

    Drug: Acetylsalicylic acid/Aspirin (100 mg)

  • Placebo comparator
    Control

    Drug: Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride

Interventions

  • DrugAcetylsalicylic acid/Aspirin (100 mg)

    Drug page: Aspirin

    Patients will receive 100 mg acetylsalicylic acid (or Aspirin) orally (tablet) once a day (or intravenously if oral administration is not possible in the acute phase of pneumonia), introduced within 84 hours of pneumonia diagnosis, for 90 days.

  • DrugPlacebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride

    patients in the placebo group will receive 100 mg placebo acetylsalicylic acid orally (tablet) once a day (or intravenously if oral administration is not possible in the acute phase of pneumonia), introduced within 84 hours of pneumonia diagnosis, for 90 days.

06

What researchers measure

Primary outcomes

  1. All-cause mortality

    Time frame: 90 days after randomization

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2028; primary completion for Oct 2031, 39 months later.

Of 41 non-industry phase 3 interventional studies under Pneumonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 57. This study's planned 39 months is above that.

Counting every sponsor, half of 67 studies reached it within 19 months; a quarter within 8 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2025
First posted
Jan 14, 2025
StartEst.
Jul 2028
Primary completionEst.
Oct 2031
CompletionEst.
Nov 2031
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06774846
Responsible party
Sponsor
First posted
Jan 14, 2025
Start date
Jul 2028 (estimated)
Primary completion
Oct 2031 (estimated)
Completion
Nov 2031 (estimated)
Last update
Sep 24, 2026

Study contacts

Alain PUTOT
Contact
a.putot@ch-sallanches-chamonix.fr
04 50 47 30 89

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Aspirin

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