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Aspirin after hospitalisation with pneumonia to prevent heart attacks and stroke

Aspirin after hospitalisation with Pneumonia to prevent cardiovascular Events randomised Controlled Trial (ASPECT)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85630652
Enrollment
6372
Registered
2022-11-03
Start date
2022-11-03
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Pneumonia - lung infection Respiratory

Interventions

Patients will be randomised 1:1 to either receive aspirin or continue with standard care (no aspirin). Participants course of aspirin: a. 2 tablets of 75mg to be taken daily for 7 days, then
b. 1 tablet of 75mg to be taken daily for 84 days The tablets will be dispensed by their treating team whilst they are in hospital. All aspirin will be taken orally. The patient will be discharged w

Sponsors

North Bristol NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 50 years and over 2. Symptoms and signs of acute lower respiratory tract infection 3. Radiographic changes in keeping with infection on chest radiograph, CT scan or lung ultrasound scan

Exclusion criteria

Exclusion criteria: 1. Already taking regular prescribed anti-platelet medication, including aspirin, clopidogrel, cangrelor, selexipag, cilostazol, dipyridamole, prasugrel, ticagrelor, abciximab, eptifibatide, tirofiban, epoprostenol, iloprost 2. A known allergy, previous important adverse reaction, or contraindication to aspirin 3. At high risk of excessive bleeding (e.g. large trauma or haemorrhage or urgent need for major surgery or uncorrectable coagulopathy) in the opinion of the treating physician 4. Hospital acquired pneumonia, defined as related to an inpatient hospital stay within the last 10 days or acquired at least 48 hours after current admission 5. Discharged without a ‘Decision to Admit’ to hospital by urgent care/emergency department 6. Unlikely to tolerate/adhere to medication regimen 7. Prisoners 8. Known to be pregnant 9. Life expectancy <3 months due to pre-existing condition (e.g. terminal malignancy) 10. Presentation more likely due to acute COVID-19 pneumonitis in the opinion of the treating physician. i.e. newly positive Polymerase Chain Reaction (PCR) or similar antigen test for COVID-19 11. Enrolment onto another study where the burden on the participant will be too high if they are enrolled onto to both. Or, if the enrolment onto both would compromise one or both of the study’s objectives. To be decided on a case-by-case basis.

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 24/10/2025: The hierarchical composite of time to cardiovascular mortality, non-cardiovascular mortality, non-fatal MI/stroke, PE/DVT and TIA/unstable angina, up to 90 days following randomisation. The trial will end for a participant after they have completed the course of study medication at 91 days post randomisation and completed the 90-day follow-up questionnaire (if one of the first 2000 participants recruited during phase 1). The end of the trial as a whole will be after all trial participants have completed follow up, all data queries have been resolved, the database locked and the analyses completed. Previous primary outcome measure: Any MACE defined using validated International classification of diseases 10 (ICD-10) codes for specified diagnoses in hospital or cardiovascular death (deaths with any of the specified ICD-10 codes coded as the underlying cause up to 90 days after randomisation. The trial will end for a participant after they have completed the course of study medication at 91 days post randomisation and completed the 90-day follow-up questionnaire (if one of the first 2000 participants recruited during phase 1). The end of the trial as a whole will be after all trial participants have completed follow up, all data queries have been resolved, the database locked and the analyses completed.

Secondary

MeasureTime frame
Current secondary outcome measures as of 24/10/2025: MACE*, all-cause mortality, cardiovascular mortality and major bleeding events up to 90 days following randomisation. MACE defined using validated International Classification of Diseases 10 (ICD-10) codes for specified diagnoses in hospital or cardiovascular death (deaths with any of the specified ICD-10 codes coded as the underlying cause up to 90 days after randomisation. Previous secondary outcome measures: Defined from routine data at 90 days post randomisation: 1. All-cause mortality 2. Cardiovascular mortality 3. Bleeding events causing hospitalisation 4. Hospital length of stay

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026