Aspirin after hospitalisation with pneumonia to prevent heart attacks and stroke

Phase 4

• Conditions: Pneumonia - lung infection; Respiratory

• Registration Number: ISRCTN85630652
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-03
• Last Update Posted: 2 September 2024
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 22600

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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 Outcome Measures

Name	Time	Method
Defined from routine data at 90 days post randomisation:<br>1. All-cause mortality;<br>2. Cardiovascular mortality;<br>3. Bleeding events causing hospitalisation;<br>4. Hospital length of stay