Acetylsalicylic Acid

Clinical trials are studying Acetylsalicylic Acid in many different patient groups, from stroke and heart disease to pregnancy, cancer, and rare conditions. These trials look at safety, effectiveness, and the best treatment plans. They also compare Acetylsalicylic Acid with placebo or other medicines in different phases of research.

Table of contents

Trial overview

The trial data show many studies of Acetylsalicylic Acid in different diseases and care settings.[1][2] These studies test whether it helps with prevention, treatment support, or long-term outcomes, and many compare it with placebo or other antiplatelet drugs.[3]

Main conditions studied

Many trials focus on cardiovascular disease, including acute coronary syndrome, myocardial infarction, coronary artery disease, atrial fibrillation, stent treatment, and bypass surgery.[4][5] Other studies look at stroke, transient ischemic attack, and brain infarction, including both symptomatic and covert (silent) brain infarction.[6][7]

There are also studies in pregnancy, such as preeclampsia prevention in twin pregnancy, chronic hypertension in pregnancy, and pregnancy after assisted reproductive technology or frozen embryo transfer.[4][8] Other trial areas include cancer, respiratory disease, sudden hearing loss, superficial venous malformations in children, and central retinal artery occlusion.[10][11]

Study designs and phases

Most studies are Phase 3 trials, which means they are larger studies used to compare treatments and measure important patient outcomes.[12] The data also include Phase 2 trials, Phase 4 trials, and low-intervention studies, showing that Acetylsalicylic Acid is being studied across different stages of research.[13]

Several trials use randomized designs, meaning participants are assigned by chance to different study groups.[14] Some are double-blind or placebo-controlled, which helps reduce bias when judging whether the treatment works.[15]

Key endpoints and what they mean

The main outcomes often measure serious events such as stroke, myocardial infarction, death, bleeding, or graft failure.[16] In heart studies, researchers often use combined endpoints like MACE or MACCE, which group several major heart and brain events into one result.[17]

Other trials measure disease-specific outcomes, such as preeclampsia before 37 weeks, recurrence of cancer, pain scores, platelet reactivity, or functional recovery after stroke.[18][19] Some studies also track quality of life, symptom scales, imaging findings, or laboratory markers like platelet aggregation and blood clotting tests.[20]

Who may participate

Eligibility depends on the disease being studied, and the trial data show very specific groups such as patients with acute ischemic stroke, people after PCI or CABG, pregnant women at risk of preeclampsia, children with venous malformations, and patients with cancer or lung disease.[21] Some trials also focus on older adults, high bleeding risk patients, or people with genetic or imaging-based findings that place them in a special risk group.[22]

Several studies compare one antiplatelet treatment against dual antiplatelet therapy, which means two drugs used together to reduce clotting risk.[23] Other studies test whether treatment can be reduced, stopped earlier, or tailored to the person’s risk profile, such as genotype-guided or CT-guided approaches.[24]

Selected trials

CANCAS studies patients with acute ischemic stroke and carotid artery stenosis who need mechanical thrombectomy and emergent carotid stenting, with the main outcome being stent patency at 24 hours.[1] ASPIRING studies survivors of intracerebral haemorrhage and asks whether starting antiplatelet monotherapy is better than avoiding antiplatelet drugs for preventing major cardiovascular or cerebrovascular events.[2]

Dan-DAPT studies patients after myocardial infarction and looks at net adverse clinical events and bleeding at 12 months, using different antiplatelet strategies.[3] ASPRE-T studies twin pregnancies and asks whether low-dose aspirin started in the first trimester can reduce preterm preeclampsia.[4]

Add-Aspirin studies people with common non-metastatic solid tumors, including breast, colon, rectal, stomach, oesophageal, and prostate cancer, and measures survival and recurrence outcomes.[10] PROTECT-U studies unruptured intracranial aneurysms and measures aneurysm rupture or growth on imaging.[11]

Patient-focused summary of the research

Across these trials, Acetylsalicylic Acid is being tested in many ways: as a preventive treatment, as part of dual therapy, as a short-term treatment after procedures, and as a long-term strategy.[12][16] The studies do not all ask the same question, but they share a common goal: to learn when Acetylsalicylic Acid helps most, and when a different strategy may be better.[18]

For patients, the most important idea is that these trials are not just testing the drug itself, but also the best way to use it in specific groups.[23] That is why the trial populations, treatment plans, and outcomes are very different from one study to another.[24]

Trial IDPhaseCondition studiedStatusEnrollment
2025-521564-35-00Phase 2Ischemic stroke with large artery occlusion and carotid stenosisAuthorised50
2024-517437-40-00Phase 2Nonsteroidal anti-inflammatory drug Exacerbated Respiratory DiseaseCompleted30
2024-513710-35-00Phase 3Sudden sensorineural hearing lossAuthorised142
2025-521452-30-01Phase 3Covert brain infarctionAuthorised1202
2024-516188-10-00Phase 3Intracerebral haemorrhageAuthorised4388
2025-521892-30-00Phase 3Coronary artery bypass grafting patientsAuthorised1703
NCT06535568Phase 3Stable or unstable coronary syndromes after PCIAuthorised576
2024-520324-29-00Phase 2Type 1 diabetes, vascular damage, diabetic kidney diseaseAuthorised332
2024-517595-38-00Phase 3Thrombotic episodes in superficial venous malformations in childrenAuthorised34
NCT05262803Phase 3Myocardial infarctionAuthorised2700
2022-500933-10-00Low InterventionPreeclampsia during pregnancyAuthorised1164
NCT05627375Phase 3Acute venous thromboembolismAuthorised1400
2022-501176-26-00Phase 3Acute ischemic stroke and high-risk transient ischemic attackAuthorised17276
NCT05754957Phase 3Acute coronary syndromeCompleted16715

Ongoing Clinical Trials on Acetylsalicylic Acid

  • Aspirin Resistance Testing in Patients 12 to 18 Months After Heart Transplantation Treated with Acetylsalicylic Acid

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria
  • Acetylsalicylic Acid for Preventing Preeclampsia in Pregnant Women

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain
  • Effect of semaglutide, acetylsalicylic acid, and clopidogrel on blood clotting in patients with diabetes or overweight with cardiovascular disease

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Italy
  • A study to compare REGN7508 and acetylsalicylic acid for preventing blood clots in adults undergoing elective total knee replacement.

    Not yet recruiting

    1 1 1
    Greece Italy
  • Effect of ramipril, acetylsalicylic acid, and atorvastatin calcium trihydrate plus nurse education on treatment adherence in patients with acute coronary syndrome

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Spain
  • Study of acetylsalicylic acid and diclofenac for treating blood clots in superficial venous malformations in children aged 6 to 17 years

    Not yet recruiting

    1 1 1
    Investigated diseases:
    France
  • Testing acetylsalicylic acid and ketorolac to reduce complications after cancer surgery in patients with high inflammation levels

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Italy
  • Testing personalized treatment with acetylsalicylic acid, clopidogrel, and ticlopidine to prevent another stroke in patients with ischemic stroke

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Italy
  • Study of Aspirin and Folic Acid Treatment for Patients with Sudden Sensorineural Hearing Loss

    Not yet recruiting

    1 1 1
    France
  • Study on Aspirin’s Effect on Platelet Aggregation in Patients with Type 1 Diabetes, Atherosclerotic Cardiovascular Disease, and Diabetic Kidney Disease

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Denmark

Glossary

  • Phase 2: A mid-stage trial that first checks if a treatment seems effective and safe in a smaller group of patients.
  • Phase 3: A larger trial that compares treatments and looks more closely at benefit and safety.
  • Phase 4: A later study done after a treatment is already in wider use, often to learn more about real-world effects.
  • Placebo: A look-alike treatment with no active study drug, used to compare results fairly.
  • Randomized: Participants are assigned by chance to different study groups.
  • Double-blind: A study design where participants and often researchers do not know who gets which treatment, to reduce bias.
  • Primary outcome: The main result the study is designed to measure.
  • MACE: Major adverse cardiac and cerebral events. This usually means serious heart or brain events such as heart attack, stroke, or cardiovascular death.
  • MACCE: Major adverse cardiac and cerebrovascular events. This is a combined measure of major heart and brain events.
  • BARC bleeding: A bleeding scale used in heart studies. Higher numbers mean more serious bleeding.
  • Preeclampsia: A pregnancy complication involving high blood pressure and other signs of illness.
  • Modified Rankin Scale (mRS): A scale that measures how well a person functions after a stroke, including daily activities and disability.

References

  1. https://clinicaltrials.gov/study/NCT02370680
  2. https://clinicaltrials.gov/study/NCT02060396
  3. https://clinicaltrials.gov/study/NCT00632086
  4. https://clinicaltrials.gov/study/NCT01379079
  5. https://clinicaltrials.eu/trial/study-on-aspirin-for-preventing-recurrence-and-improving-survival-in-patients-with-stage-ii-and-iii-colon-cancer/
  6. https://clinicaltrials.eu/trial/study-on-low-dose-acetylsalicylic-acid-to-prevent-preeclampsia-in-pregnant-women-after-frozen-embryo-transfer/
  7. https://clinicaltrials.gov/study/NCT02482857
  8. https://clinicaltrials.gov/study/NCT02326779