Aspirin Summaries
The future for aspirin – 2023 clinical trials update
This summary celebrates the continuing research interest in aspirin and gives us a taste of potential developments in the role aspirin may play in future healthcare.
A search of recruiting and not yet recruiting trials on the U.S National Library of Medicine Clinical Trials.gov platform gives 159 trials for aspirin. This is very active for a drug that is over 125 years old and to put it into context with other medicines the same search was conducted for clinical trials of some commonly used medications with the following results:
- Betablockers = 49 trials
- Statins = 95 trials
- Paracetamol = 76 trials
- Prednisolone = 76 trials
- Amoxicillin = 40 trails
- Ramipril = 7 trials
- Metformin = 209 trials
Aspirin trials were being organised across USA [32], Canada [13], Brazil [4], Europe, [44], Africa [3], Asia [46] and
Australia [1].
The conditions being studied for aspirin were also diverse and included:
- Coronary Heart Disease (including coronary artery disease, peripheral artery disease and cardiovascular
- disease in general) = 33 trials
- Pregnancy, pre-eclampsia, postpartum = 29 trials
- Cancer prevention and management= 26 trials
- Neurology including stroke prevention and management = 18 trials
- Surgery = 11 trials
- Aspirin tolerability, side effects, aspirin exacerbated respiratory disease (AERD) = 9
- Diabetes = 5 trials
- Aspirin pharmacology- timings body weight etc. =5
- Pain = 4 trials
- Psychiatry = 4
- Covid-19 = 3 trials
- Blood disorders= 3
- Renal (chronic kidney disease) = 2 trials
- Tuberculosis = 2 trials
- Respiratory/COPD = 2
- NAFLD= 1
- Sepsis = 1
Inflammatory processes in many conditions are an attractive target for aspirin therapy. Perhaps it may be true that ‘an
aspirin a day keeps the doctor away’.
The following is a summary of the design of some the trials first listed between June 2022 and July 2023 giving a taster
of what the future may hold for aspirin if they reach their primary end points.
References
Pregnancy/postpartum
ClinicalTrials.gov Identifier: NCT05653973
Title: Prenatal Aspirin and Postpartum Vascular function
The aim of this study is to gain greater understanding as to how low dose aspirin reduces vascular dysfunction in postpartum women experiencing preeclampsia.
Recruitment status: Recruiting
First posted: 07/12/22
Lasted updated post: 16/12/22
Location: US
Phase: Early phase 1
Estimated enrolment: 60
Intervention arm: Experimental assessment of microvascular function, single group assignment
Design: Interventional, basic science
Estimated primary competition date: 31/03/2025
Estimated study competition date: 30/04/2025
ClinicalTrials.gov Identifier: NCT05557877
Title: Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer
Can low-dose aspirin affect markers of inflammation in blood and tissue and thereby prevent postpartum related breast cancer?
Recruitment status: Recruiting
First posted: 08/09/22
Lasted updated post: 19/05/23
Location: US
Phase: Phase 2
Estimated enrolment: 100
Intervention arm: Low dose aspirin
Design: Interventional single group assignment
Estimated primary competition date: 30/01/2026
Estimated study competition date: 30/01/2027
Primary outcome measure: Change in pregnancy related breast cancer
ClinicalTrials.gov Identifier: NCT05709483
Title: Predictors of Aspirin Failure in Preeclampsia Prevention
Despite currently being the most beneficial prophylactic approach for preeclampsia, aspirin failure to reduce hypertensive disorders of pregnancy is not uncommon. The aim of this study is to understand the role of a genetic variant in the PAR4 receptor expressed on platelets and explore whether it is associated with increased platelet function and possible aspirin failure.
Recruitment status: Recruiting
First posted: 02/02/2023
Lasted updated post: 07/04/2023
Location: US
Phase: Early phase 1
Estimated enrolment: 130
Intervention arm: Thromboxane A2 levels measured at baseline and 1 hour after administration of 81 mg of aspirin
Design: Nonrandomised, parallel assignment, basic science
Estimated primary competition date: 01/11/2024
Estimated study competition date: 01/11/2024
Thrombocytopenia
ClinicalTrials.gov Identifier: NCT04912505
Title: ASPirin in Immune thRombocytopenia Patients with Cardiovascular disease
This study aims to assess the pharmacodynamics of once daily aspirin in people with thrombocytopenia.
Recruitment status: Recruiting
First posted: 03/06/2021
Lasted updated post: 10/03/2023
Location: France
Sponsors and collaborators: University Hospital, Toulouse
Phase: 2
Estimated enrolment: 10
Intervention arm: Aspirin
Design: Interventional single group assignment
Estimated primary competition date: 01/06/2023
Estimated study competition date: 01/09/2023
Primary outcome measure: platelet production of thromboxane B2 24 hours after a 75 mg aspirin intake
Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov Identifier: NCT05265299
Title: Trial to determine effective aspirin dose in COPD
COPD treatments currently focus on inhaler therapies for the lungs and do not target the impact of COPD in other body systems. Recent evidence suggests activated platelets, which are involved in inflammatory processes may make respiratory symptoms worse independent of CVD. It is interesting that patients with COPD taking aspirin have been shown to have improved respiratory symptoms, fewer COPD flares and lower mortality. The investigators intend to explore in a larger clinical trial whether aspirin use can improve respiratory symptoms independent of CVD but this initial study aims to find the best dose of aspirin for blocking platelet activation in this population and to find out if blood or urine tests can help us understand the response to therapy.
Recruitment status: Recruiting
First posted: March 3, 2022
Lasted updated post: 17/05/2023
Location: USA
Sponsors: John Hopkins University, National Heart, Lung, and Blood Institute (NHLBI)
Phase: 3
Estimated enrolment: 48 participants
Intervention arm: Aspirin 81 mg once daily, aspirin 162 mg once daily or aspirin 325 mg once daily
No intervention arm: 0
Design: Interventional, randomised sequential assignment with 6-sequence, 3-period, 3- treatment sequential crossover trial
Estimated primary competition date: December 2026
Estimated study competition date: December 2026
Primary outcome measure: Change in urinary 11-dehydro-thromboxane B2 level – a urinary metabolite of thromboxane A2
Secondary outcome measures: Change in proportion of platelets displaying CD62P, CD63, CD154 and PAC1 at 2, 6 and 10 weeks after stimulation with U46619, a thromboxane A2 agonist.
Cancer
ClinicalTrials.gov Identifier: NCT05865548
Title: Addition of Aspirin to Standard of Care in Oral Cancer
Is the impact of aspirin on cancer survival and prevention of recurrence linked to specific genes?
Recruitment status: Recruiting
First posted: 19/05/2023
Lasted updated post: 24/05/2023
Location: India
Sponsor:Banaras Hindu University
Estimated enrolment: 60
Intervention arm: Aspirin 150 mg daily plus standard care
No intervention arm: standard care
Design: Randomised parallel assignment
Estimated primary competition date: 30/09/2024
Estimated study competition date: 30/09/2024
Primary outcome measure: Number of patients with treatment related adverse events
Secondary outcome measures: Disease free survival, overall survival
Cardiovascular disease
ClinicalTrials.gov Identifier: NCT05347069
Title: Efficacy and Safety of Aspirin in Patients with Chronic Coronary Syndromes Without Revascularization.
Recruitment status: Recruiting
First posted: 26/04/2022
Lasted updated post: 17/08/2022
Location: Japan
Sponsor/collaborator: Takeshi Morimoto
Phase: 4
Estimated enrolment: : 2890 participants
Intervention arm: Aspirin 100 mg daily
No intervention arm: No aspirin
Design: Interventional, randomised, parallel assignment, open label
Estimated primary competition date: March 2030
Estimated study competition date: December 2030
Primary outcome measure: Composite cardiovascular events
Psychiatry
ClinicalTrials.gov Identifier: NCT05615948
Title: Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression
The aim of this study is to assess the effect of aspirin and ketamine as a therapy for people with treatment resistant depression.
Recruitment status: Recruiting
First posted: 14/11/2022
Lasted updated post: 05/07/2023
Location: USA
Sponsor:Maimonides Medical Center
Phase: 4
Estimated enrolment: 20
Intervention arm: Aspirin 486 mg and 80 mg ketamine
Design: Interventional, open label, single group assignment
Estimated primary competition date: 31/10/2023
Estimated study competition date: 31/10/2023
Primary outcome measure: Change in depressive symptoms on the Montgomery-Asberg Depression Rating Scale (MADRAS)
Preventing blood clots after joint replacement surgery
ClinicalTrials.gov Identifier: NCT04295486
Title: Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression
The aim of this study is to find out if aspirin 81 mg once daily is as effective as 81 mg twice daily for preventing VTE after total joint replacement surgery.
Recruitment status: Recruiting
First posted: 04/03/2020
Lasted updated post: 02/03/2023
Location: USA
Sponsor: University of Miami
Phase: 2
Estimated enrolment: 5478
Intervention arm: 81 mg aspirin non-enteric coated tablet once daily from the night before surgery until 28 days post-surgery
No intervention arm/comparator arm: 81 mg non-enteric coated aspirin tablet from the night before surgery and then morning and night until 28 days post-surgery
Design: Interventional, randomised, parallel assignment open label
Estimated primary competition date: May 1, 2024
Estimated study competition date: May 1, 2024
Primary outcome measure: incidence of symptomatic thromboembolic events (PE and VTE) over 90 days.