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ASPAPY - Aspirin in acute pneumonia in the elderly: a multicenter, double-blind, randomized, placebo-controlled trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510811-32-00
Acronym
ASPAPY
Enrollment
600
Registered
2024-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pneumonia

Brief summary

All-cause mortality at D90 after randomization

Detailed description

EFFICACY: All-cause mortality at D30 and D120, EFFICACY: CV mortality at D30, D90 and D120 (i.e. mortality related to major CV events*), EFFICACY: Occurrence of major CV events (composite endpoint including at least one of the following: *myocardial infarction, stroke, heart failure, new atrial fibrillation, pulmonary embolism, CV death, sudden death) within 30 days, 90 days and 120 days of randomization, EFFICACY: Number of days in intensive care or resuscitation unit within 30 days and 90 days of randomization, EFFICACY: Occurrence of re-hospitalization (unscheduled hospitalization) within 30 and 90 days of randomization, EFFICACY: Duration in days of first hospitalization (excluding follow-up care, rehabilitation and long-term care units), EFFICACY: Proportion of newly institutionalized patients (i.e. entering a nursing home) at D90 and proportion of patients with a decrease ≥ 1 point on the activity of daily living (ADL) scale between their pre-randomization status and D90, EFFICACY: Time (in days) to death from any cause, end of study (D120) or date of last follow-up, whichever comes first, EFFICACY: Time (in days) to major CV event, death, end of study (D120) or date of last follow-up, whichever comes first, TOLERANCE: Frequency of major bleeding events (BARC classification >2) within 30 days, 90 days and 120 days of randomization, TOLERANCE: Frequency of bleeding events (any severity) within 30 days, 90 days and 120 days of randomization

Interventions

DRUGACIDE ACETYLSALICYLIQUE PANPHARMA 500 mg
DRUGpoudre pour solution injectable
DRUGCHLORURE DE SODIUM 0
DRUGsolution pour perfusion
DRUGPlacebo d'acide acétylsalicylique

Sponsors

Centre Hospitalier Universitaire De Dijon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
All-cause mortality at D90 after randomization

Secondary

MeasureTime frame
EFFICACY: All-cause mortality at D30 and D120, EFFICACY: CV mortality at D30, D90 and D120 (i.e. mortality related to major CV events*), EFFICACY: Occurrence of major CV events (composite endpoint including at least one of the following: *myocardial infarction, stroke, heart failure, new atrial fibrillation, pulmonary embolism, CV death, sudden death) within 30 days, 90 days and 120 days of randomization, EFFICACY: Number of days in intensive care or resuscitation unit within 30 days and 90 days of randomization, EFFICACY: Occurrence of re-hospitalization (unscheduled hospitalization) within 30 and 90 days of randomization, EFFICACY: Duration in days of first hospitalization (excluding follow-up care, rehabilitation and long-term care units), EFFICACY: Proportion of newly institutionalized patients (i.e. entering a nursing home) at D90 and proportion of patients with a decrease ≥ 1 point on the activity of daily living (ADL) scale between their pre-randomization status and D90, EFFICAC

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026