Aspirin to prevent cardiovascular events in patients with pneumonia or influenza

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

27 Dec 2023 → ongoing

Decision date (initial)

2023-09-15

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To investigate whether adding aspirin to standard therapy in patients with moderate to severe community-acquired pneumonia or influenza will reduce the incidence of acute coronary syndrome in hospitalized patients

Secondary objectives 2

1. To investigate the effects of adding aspirin to standard therapy, with regard to other cardiovascular events, length of hospital stay, mortality, adverse events, and cost-effectiveness.
2. In the subgroup of patients who agree with additional blood-sampling and storage: To allow for future studies identifying the mechanisms of cardiovascular events in patients with pneumonia or influenza, and to investigate the effect of aspirin on these mechanisms.

Conditions and MedDRA coding

Influenza

Regulatory references

Plan to share IPD

Yes

IPD plan description

The deidentified individual participant data (IPD) collected during the trial, along with the study protocol and statistical analysis plan, will be made available immediately after publication of the main study results. Access will be granted to investigators with an approved proposal, as determined by the ASCAP study data access committee. Data requestors will be required to sign a data access agreement, upon which data will be available at a third-party website.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 40 years or older
2. Any of the following respiratory infections: moderate to severe community-acquired pneumonia (defined as clinical signs of pneumonia, radiological evidence of a new infiltrate consistent with pneumonia, and severity score CURB-65 score ≥2 or PSI score ≥3) or influenza (defined as clinical signs of a respiratory infection and a positive influenza PCR test result).
3. Admitted to hospital

Exclusion criteria 6

1. Conditions which require antiplatelet therapy
2. Use of vitamin K antagonists, direct oral anticoagulants or therapeutic LMWH
3. Contraindications for aspirin: recent (<1 month) hemorrhagic CVA, recent major gastro-intestinal bleeding or other hemorrhage, active bleeding, thrombocytopenia < 100, known hemorrhagic diathesis, allergy for salicylates.
4. Uncontrolled hypertension (systolic BP>180 mm Hg or diastolic BP>110 mm Hg)
5. Life expectancy less than one month
6. Pregnancy or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of an acute coronary syndrome (ACS) up to day 180

Secondary endpoints 6

1. Incidence of 4-point MACE (nonfatal stroke, nonfatal myocardial infarction, cardiovascular death and coronary revascularization) up to day 180
2. Incidence of major bleeding complication and clinically relevant non-major bleeding up to day 90
3. Length of hospital stay
4. Mortality at day 90 and day 180
5. Societal costs up to day 180 measured with IMCQ and IPCQ
6. Health-related quality of life measured with the EQ-5D-5L

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

prof. dr. J.M. Prins

Public contact point

Organisation

Amsterdam UMC

Contact name

prof. dr. J.M. Prins

Locations

1 EU/EEA country · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications