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All ASPIRIN SUMMARIES

ISSUE 2022 (4) 125yr Edition

Aspirin Summaries Issue 2022 (4) 125yr Edition

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Aspirin Summaries : 125 Years of aspirin (Issue 4) : The future for aspirin

This issue celebrates the continuing research interest in aspirin and gives 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 over 170 trials for aspirin. This is very active for a drug 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 = 60 trials
  • Statins = 95 trials
  • Paracetamol = 80 trials
  • Prednisolone = 79 trials
  • Amoxicillin = 31 trails
  • Ramipril = 6 trials
  • Metformin = 214 trials

Aspirin trials were being organised across USA, Canada, Europe, Asia and Australia with lots of research interest in the US (38 trials), Europe (47 trials) and China (26 trials).

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) = 50 trials
  • Cancer prevention and management= 30 trials
  • Pregnancy, pre-eclampsia, postpartum = 25 trials
  • Neurology including stroke prevention and management = 15 trials
  • Surgery (orthopaedic, neurology, gastroenterology) = 5 trials
  • Diabetes = 4 trials
  • Covid-19 = 4 trials
  • Pain = 3 trials
  • Renal (chronic kidney disease/renal transplant/kidney stone) = 3 trials
  • Tuberculosis = 2 trials

As well as aspirin tolerability and side effects, aspirin exacerbated respiratory disease (AERD); aspirin dosing/formulation, drug interactions, body weight considerations; essential thrombocythemia; NAFLD; sepsis; thyroid; neurodevelopment; COPD; Bipolar disease and depression.

Inflammatory process 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 of these trials giving a taster of what the future may hold for aspirin if they reach their primary end points.

References

https://www.clinicaltrials.gov/

Renal/Chronic Kidney Disease (CKD)

ClinicalTrials.gov Identifier: NCT03796156

Title: Aspirin to Target Arterial Events in Chronic Kidney Disease (ATTACK)

CKD is linked to an increased risk of having a cardiovascular event. This primary cardiovascular disease (CVD) prevention study aims to explore whether people with CKD could benefit from taking 75mg of aspirin daily to reduce their risk of experiencing a first cardiovascular event.

Recruitment status: Recruiting

First posted: January 8, 2019

Lasted updated post: January 18, 2022

Location: UK

Sponsor: University of Southampton

Phase: 3

Estimated enrolment: 25210 participants from general practice with CKD [stage 5 excluded]

Intervention arm: 75mg low dose non-enteric coated or dispersible once daily aspirin added to usual medication

No intervention arm: Usual medication only

Design: Interventional, randomized, parallel assignment

Estimated primary competition date: December 2025 Estimated study competition date: December 2025

Primary outcome measure: Number of participants with a major vascular event.

ClinicalTrials.gov Identifier: NCT04381143

Title: ASPIrin in Reducing Events in Dialysis (ASPIRED)

Individuals who have kidney failure requiring dialysis also have a much higher risk of developing CVD. For those with end stage kidney disease (ESKD) 58% of all mortality is from a cardiac cause. People with ESKD also have an increased risk of clotting and an  increased risk of bleeding. This study aims to test if aspirin can improve outcomes for this population.

Recruitment status: Recruiting

First posted: May 8, 2020

Lasted updated post: January 24, 2022

Location: China

Sponsors and collaborators: Guangdong Provincial People’s Hospital and George Clinical Pty Ltd

Phase: 4

Estimated enrolment: 9000 participants

Intervention arm: Aspirin 100 mg oral tablet daily

No intervention arm: Placebo tablet 1 daily

Design: Interventional randomised, parallel assignment

Estimated primary competition date: July 2025

Estimated study competition date: July 2026

Primary outcome measure: Number of participants with a composite of major cardiovascular events.

 

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: Not yet recruiting

First posted: March 3, 2022

Lasted updated post: March 3, 2022

Location: USA

Sponsor: John Hopkins University, National Heart, Lung, and Blood Institute (NHLBI)

Phase: 3

Estimated enrolment: 48 participants

Intervention arm: Aspirin 81 mg once daily, aspirin 162mg 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.

 

Nonalcoholic Fatty Liver Disease (NAFLD)

ClinicalTrials.gov Identifier: NCT04031729

Title: Aspirin for the treatment of Nonalcoholic Fatty Liver Disease

Nonalcoholic fatty liver disease (NAFLD) is characterised by fatty infiltration of the liver in the absence of excessive alcohol consumption. NAFLD can develop into inflammatory nonalcoholic steatohepatitis (NASH) which can in turn lead onto liver cirrhosis and failure. In this study aspirin is given to reduce intrahepatic lipid content quantified via 1H magnetic resonance spectroscopy (1H-MRS).

Recruitment status: Recruiting

First posted: July 24, 2019

Lasted updated post: February 24, 2022

Location: USA

Sponsor: Massachusetts General Hospital

Phase: 1 and 2

Estimated enrolment: 80

Intervention arm: Aspirin 81 mg once daily

No intervention arm: Placebo oral tablet once daily

Design: Interventional, randomised parallel assignment

Estimated primary competition date: January 2024

Estimated study competition date: September 2024

Primary outcome measure: Percent intrahepatic lipid content, quantified by 1-H-MRS

 

Pregnancy/preeclampsia/postpartum

ClinicalTrials.gov Identifier: NCT03961360

Title: Effectiveness of Higher Aspirin dosing for Prevention of preeclampsia in High Risk Obese Gravida (ASPREO)

This study compares aspirin 81 mg dosing with aspirin 162 mg dosing for reducing the incidence of preeclampsia in women with a BMI over 30 with a singleton gestation less than 20 weeks who have either had a history of preeclampsia in a previous pregnancy
or have stage 1 hypertension or pre-gestational diabetes.

Recruitment status: Recruiting

First posted: May 23, 2019

Lasted updated post: June 11, 2021

Location: USA

Sponsor: The University of Texas Health and Science Center, Houston

Phase: 2 and 3

Estimated enrolment: 220 participants

Intervention arm: Aspirin 81 mg or aspirin 162 mg

No intervention arm: 0

Design: Interventional, randomised, parallel assignment

Estimated primary competition date: May 6, 2019 Estimated study competition date: May 1, 2022

Primary outcome measure: Preeclampsia.

 

Psychiatry

ClinicalTrials.gov Identifier: NCT03152409

Title: Salicylic Augmentation in Depression (SAD)

This study is designed to investigate whether aspirin in conjunction with antidepressant medication can reduce symptoms of depression. The investigators also hope to learn if some people respond better to aspirin than others and if it is possible to predict who  these individuals maybe through a blood test.

Recruitment status: Recruiting

First posted: May 15, 2017

Lasted updated post: August 2, 2021

Location: USA

Sponsor: Columbia University

Phase: 2

Estimated enrolment: 74

Intervention arm: Aspirin 325 mg

No intervention arm: Placebo oral tablet

Design: Interventional, randomised, parallel assignment

Estimated primary competition date: December 2022 Estimated study competition date: December 2023

Primary outcome measure: Change in Hamilton Depression score over 8 weeks, change in HDRS score in the treatment versus control groups.

ClinicalTrials.gov Identifier: NCT05035316

Title: Effects of low Dose aspirin in bipolar disorder (The A-Bipolar RCT)Bipolar disease (BD) is now being understood to be a multisystem disorder with abnormalities of inflammation, oxidative stress imbalance, neurotrophic deficiencies and telomere  shortening. Due to the role of inflammation in BD it is proposed that aspirin may be protective against the onset and deterioration in BD. This randomised controlled trial seeks to explore the risk benefit for aspirin and clarify its role in the different stages of BD. The investigators have developed a unique smart phone mood self-assessment tool, the Monsenso system, for monitoring, diagnosing and treating BD, they intend to use this to assess whether adding low dose aspirin to standard drug treatment improves
mood stabilisation.

Recruitment status: Recruiting

First posted: September 5, 2021

Lasted updated post: April 8, 2022

Location: Denmark

Sponsor: Lars Vedal Kessing

Phase: 2

Estimated enrolment: 250 participants

Intervention arm: Aspirin 150 mg 1 tablet daily

No intervention arm: Placebo (blinded) calcium tablet

Design: Intervention, randomised, double-blinded,parallel assignment

Estimated primary competition date: January 2024

Estimated study competition date: January 2024

Primary outcome measure: Daily self-reported mood instability collected via the Monsenso system at 6 months (and 12 months for subgroup of participants).

 

Post-surgical venous thromboembolism prophylaxis

ClinicalTrials.gov Identifier: NCT05104229

Title: SAVES-IBD:Safety and efficacy of aspirin vs.standard of care for VTE prophylaxis after IBD surgery (SAVES-IBD) Individuals undergoing surgery for inflammatory bowel disease are at increased risk of developing a venous thromboembolism (VTE) such as a deep vein thrombosis (DVT), pulmonary embolism (PE) and mesenteric vein thrombosis in the 90 days following surgery. Current standard of care is heparin whilst in hospital only. A large, randomised trial with over 3000 patients undergoing hip or knee  replacement has found that aspirin 81 mg twice daily post discharge was equivalent to anticoagulant prophylaxis with a factor  Xa inhibitor.  The aim of this study is to assess the efficacy and safety of a post IBD surgery 30-day regimen of aspirin 81 mg twice daily for 30 days compared with standard of care.

Recruitment status: Not yet recruiting

First posted: November 2, 2021

Lasted updated post: February 8, 2022

Location: USA

Sponsor: The Cleveland Clinic

Phase: 3

Estimated enrolment: 1890

Intervention arm: Aspirin 81 mg Enteric coated tablet twice daily starting the day after surgery until hospital discharge and then for 30 days

No intervention arm: Standard of care VTE prophylaxis

Design: Inverventional, prospective, multicentre, parallel assignment, open label

Estimated primary competition date: May 2023

Estimated study competition date: January 2024

Primary outcome measure: VTE rate 30 days after discharge following surgery for IBD.

ClinicalTrials.gov Identifier: NCT04295486

Title: Optimal dosing for low-dose aspirin chemoprophylaxis for VTE following total joint arthroplasty 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: March 4, 2020

Lasted updated post: March 29, 2022

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, 2023

Estimated study competition date: May 1, 2023 Primary outcome measure: incidence of symptomatic thromboembolic events (PE and VTE) over 90 days.

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Djp

Daniel José Piñeiro

ASSOCIATE
Name
Daniel José Piñeiro
Academic Affiliations:
Full Professor of Medicine, Universidad de Buenos Aires, Argentina Trustee, Board of Trustees, American College of Cardiology
Professional Setting:
My academic experience includes more than 40 years as a practicing medical doctor, teacher, and researcher. I have fulfilled these appointments in settings of vital social engagement and impact, most notably at the Hospital de Clínicas “José de San Martín” of the Universidad de Buenos Aires, a public hospital with high academic recognition. Additionally, I currently hold the position of Full Professor of Medicine at that same University.
Academic Activities:
  • International Meetings Participations: 180
  • Books-Editor: 1
  • Books Chapters: 39
  • Refereed Full Articles: 118 (listed in Pubmed: 29)
  • Refereed Abstracts: 221
  • Editorial Boards: 10
Profesional Associations:
  • 2005 President, Sociedad Argentina de Cardiología.
  • 2011-2013 President, Inter-American Society of Cardiology.
  • 2011-2013 Member (ex-officio), Board of Directors, World Heart Federation
  • 2017-2018 Member (at large), Board of Directors, World Heart Federation
  • 2018-2021 Trustee, Board of Trustees, American College of Cardiology
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Chia

John Chia

Name
John Chia MBBS (Spore), MRCP (UK), FAMS (Spore)
Academic Affiliations:

Adjunct Associate Professor DUKE-NUS Graduate Medical School,
Consultant Oncologist Curie Oncology Singapore,
Visiting Consultant National Cancer Centre Singapore.

Discipline:

Medical Oncology

Scientific Interests:
  • Aspirin as adjuvant therapy in established cancers
  • Adoptive T cell therapy and Dendritic cell vaccines in the treatment of solid tumors
  • Clinical Trial Design and Management
Declaration of Conflicts of Interest:

In the past 3 years, I have received consultant fees from Tessa Therapeutics, Aslan Pharmaceuticals, Novartis, and AstraZeneca.

I received grant support for investigator-initiated research from:

  • National Medical Research Council Singapore
  • Bayer AG

I hold shares in:  Roche, BMS, AstraZeneca, Incyte, Teva Pharmaceuticals, Trillium Therapeutics, Compugen, Arrowhead pharmaceuticals, Emergex, QuantumDx and Halozyme Therapeutics

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Badimon

Lina Badimon

Name
Lina Badimon BSc, PharmD, PhD, FESC, FAHA
Academic Affiliations:
Director of the Cardiovascular Science Program (ICCC) at the Hospital Santa Creu and San Pau, IIB-Sant Pau; CIBER CV. Director of the Cardiovascular Research Chair of the Autonomous University of Barcelona and Director of the UNESCO Chair in Biomedical Sciences Training and Research.
Discipline:
Pharmacology, Cardiovascular Disease
Scientific Interests:
Cardio-metabolic diseases, thrombosis, atherosclerosis and ischemic heart disease
Declaration of Conflicts of Interest:

I received consultant and speakers fees from Amgen, AstraZeneca, Bayer, Lilly and Sanofi.

    Return to Scientific Advisory Board
    Ge

    Junbo Ge

    Name

    Junbo Ge

    Ge Junbo, male, was born in Wulian, Shandong province on Nov. 8, 1962. He is the member of Chinese Academy of Sciences, professor and doctoral supervisor. He received his doctor’s degree of Medicine from German Mayence University in 1993 and now works as the director for Shanghai Institute of Cardiovascular Disease and the Center for Stem Cells and Tissue Engineering, Fudan University. He is also the designate chairman of the Cardiovascular Disease Branch of Chinese Medical Association, council member of the Cardiovascular Angiography and Interventions Association, international consultant of the American Heart Association. In Dec. 2013, he was appointed as the vice president of Tongji University.

    Prof. Ge has been engaged in clinical and scientific research work of cardiovascular disease since 1987, and his research area covers the pathogenesis of coronary heart disease, early diagnosis and treatment plan optimization.

    Return to Scientific Advisory Board
    Langley

    Ruth Langley

    Name
    Ruth Langley PhD, FRCP
    Academic Affiliations:
    Professor of Oncology and Clinical Trials, MRC Programme Leader and Chair of the Cancer Group, MRC Clinical Trials Unit at UCL, honorary consultant in medical oncology at the Brighton and Sussex University Hospital.
    Discipline:
    Medical oncologist; trialist
    Scientific Interests:
    • Aspirin
    • Gastro-oesophageal malignancy
    • Transdermal oestrogen in the treatment of prostate cancer
    • Trials methodology
    Declaration of Conflicts of Interest:
    Has received honorarium from Bayer
    Return to Scientific Advisory Board
    Chan

    Andrew T Chan

    Name
    Andrew T. Chan MD, MPH
    Academic Affiliations:
    Chief, Clinical and Translational Epidemiology Unit, Vice Chair, Division of Gastroenterology, Massachusetts General Hospital, Boston, Co-leader, Cancer Epidemiology Program, Dana-Farber/Harvard Cancer Center, Boston.
    Discipline:
    Gastroenterology
    Scientific Interests:
    • The role of aspirin in the prevention of colorectal cancer and other cancers
    • The role of the gut microbiome in colorectal cancer and other chronic gastrointestinal diseases, including inflammatory bowel disease and diverticulitis
    • The role of diet and lifestyle in colorectal cancer and other chronic gastrointestinal cancers
    Declaration of Conflicts of Interest:

    AACR Honors Dr. Andrew T. Chan With 2019 AACR-Waun Ki Hong Award

    Click here to find the press release.

    I received consultant Bayer and Pfizer, Inc.

    I received grant support for investigator-initiated research from:

    • National Institutes of Health
    • National Cancer Institute
    • Crohn’s and Colitis Foundation
    • Bayer AG
    Return to Scientific Advisory Board
    Gaziano

    Mike Gaziano

    Name
    J Michael Gaziano MD, MPH
    Academic Affiliations:

    Professor of Medicine, Harvard Medical School; Chief Division of Aging, Brigham and Women’s Hospital; Director of Preventive Cardiology and Director of Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System.
    Discipline: Cardiology and Epidemiology

    Scientific Interests:
    I am a chronic disease epidemiologist with a particular interest in the roles that individual lifestyle choices (diet, exercise, smoking), metabolic factors (obesity, high cholesterol, and hypertension), and biochemical and genetic markers play on the risk of cardiovascular disease and other chronic illnesses. Also, of interest is the impact that vascular disease has on other organ systems, including cognitive dysfunction and renal disease. I have an interest in the design of large-scale trials and observational studies nested in large health care systems using big data analytic techniques.
    Declaration of Conflicts of Interest:

    I received consultant and speaker fees Bayer.

    I received grant support as a principal investigator or co-investigator for research from the VA, DOD, NIH, Merck and Kowa.

    Return to Scientific Advisory Board
    Pierre A Web Photo

    Pierre Amarenco

    Name

    Pierre Amarenco, MD, FAHA, FAAN

    Academic Affiliations:
    • Professor of Neurology at Paris-Diderot Sorbonne University 
    • Chairman of the Department of Neurology and Stroke Center; Bichat University Hospital
    • Co-Director INSERM Unit-698 “Clinical Research in Atherothrombosis”
    Discipline:

    Neurology and Vascular Neurology

    Scientific Interests:
    • Understanding and preventing stroke and vascular diseases
    • Clinical trials in prevention of vascular diseases
    • Carotid intima-media thickness studies
    • Lipid trials: prevention and therapeutic –protective- evaluation
    Declaration of Conflicts of Interest:

    N/A

    Return to Scientific Advisory Board
    CarloPatrono

    Carlo Patrono

    CHAIR
    Name
    Carlo Patrono MD, FESC, FRCP
    Academic Affiliations:
    Adjunct Professor of Pharmacology at the Catholic University School of Medicine in Rome (Italy) and at the Perelman School of Medicine of the University of Pennsylvania in Philadelphia (USA).
    Discipline:
    Clinical Pharmacology
    Scientific Interests:
    • Studying platelet activation and inhibition in diabetes mellitus
    • Studying platelet activation and inhibition in myeloproliferative neoplasms
    • Investigating the mechanism of action of low-dose aspirin in preventing colorectal cancer
    Declaration of Conflicts of Interest:

    I received consultant and speakers fees from Acticor Biotech,  Amgen,  Bayer, GlaxoSmithKline,  Tremeau,  Zambon.

    I received grant support for investigator-initiated research from:

    • AIFA (Italian Drug Agency)
    • Bayer AG
    • Cancer Research UK
    • European Commission, FP6 and FP7 Programmes

      Return to Scientific Advisory Board

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