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

Study acronym: ASPAPY
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 4 months later May 2029 → Oct 2031
See other at-risk trials from Centre Hospitalier Universitaire Dijon

Record History

  1. Notable Primary completion pushed from May 2029 to Oct 2031 Start date: Feb 2026 to Jul 2028 · Completion pushed from Jun 2029 to Nov 2031 · Interventions: Acetylsalicylic acid/Aspirin (100 mg) (Drug), Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride (Drug) to Acetylsalicylic acid/Aspirin (100 mg) (Drug), Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride (Drug) · 1 more Show 4 more changesShow less
    • Start date: Feb 2026 to Jul 2028
    • Completion pushed from Jun 2029 to Nov 2031
    • Interventions: Acetylsalicylic acid/Aspirin (100 mg) (Drug), Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride (Drug) to Acetylsalicylic acid/Aspirin (100 mg) (Drug), Placebo acetylsalicylic acid (100 mg) / 0.9% sodium chloride (Drug)
    • Eligibility criteria expanded, about 8 words
  2. Notable Primary completion date: May 2028 to May 2029 Start date: Feb 2025 to Feb 2026 · Completion date: Jun 2028 to Jun 2029 · Eligibility criteria expanded, about 24 wordsv2 Show 3 more changesShow less
    • Start date: Feb 2025 to Feb 2026
    • Completion date: Jun 2028 to Jun 2029
    • Eligibility criteria expanded, about 24 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06774846
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Acute Pneumonia, Elderly Person
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov