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Recruiting NCT05347069

Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization

Phase IV Interventional Stable Angina Pectoris Coronary Artery Disease Ischemic Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin, No aspirin.
Who it may be relevant to
Registry conditions: Stable Angina Pectoris, Coronary Artery Disease, Ischemic Heart Disease. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this study is to evaluate the efficacy and safety aspirin in patients with chronic coronary syndromes without revascularization.

Detailed description

Aspirin for secondary prevention in the acute phase of acute coronary syndromes has been established. Although it is still disputable about the duration, there is also a consensus for antiplatelet therapy in patients after percutaneous coronary revascularization. On the other hand, several large randomized clinical trials (RCTs) have shown that aspirin treatment for primary prevention of cardiovascular events increases bleeding events and does not provide net clinical benefit.Patient with chronic coronary syndromes (CCS) but not eligible for revascularization do not belong to any of these categories and there is no evidence on the efficacy of aspirin in this population. Therefore, we designed a multicenter, randomized, open-label study to evaluate the efficacy and safety of aspirin in patients with CCS who are not eligible for revascularization.

Interventions

  • Drug Aspirin
    Aspirin 100 mg/day
  • Drug No aspirin
    No aspirin administered

Primary outcome measures

  • Composite cardiovascular events [Time frame: 5 years]
Secondary outcome measures (12)
  • All-cause death [Time frame: 5 years]
  • Myocardial infarction [Time frame: 5 years]
  • Ischemic stroke [Time frame: 5 years]
  • Coronary revascularization [Time frame: 5 years]
  • Peripheral revascularization [Time frame: 5 years]
  • Critical limb ischemia [Time frame: 5 years]
  • Cardiovascular death [Time frame: 5 years]
  • Major bleeding [Time frame: 5 years]
  • Hospital admission for heart failure [Time frame: 5 years]
  • Cancer incidence [Time frame: 5 years]
  • Cancer death [Time frame: 5 years]
  • Composite of all-cause mortality, myocardial infarction, ischemic stroke, coronary revascularization, lower extremity revascularization, critical lower extremity ischemia, major bleeding, hospital admission for heart failure, cancer death [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Patients with chronic coronary syndromes with ≧50% diameter stenosis in one or more major coronary vessels/major branches on coronary CT or coronary angiography but not eligible for coronary revascularization
  • Patients for whom consent can be obtained

Exclusion criteria

  • Patients with history of acute coronary syndromes (ACS)
  • Patients with history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • Patients with left main trunk stenosis (≥50%)
  • Patients for whom aspirin administration is mandatory
  • Patients undergoing antithrombotic therapy other than aspirin
  • Patients with atrial fibrillation
  • Patients with history of stroke within six months
  • Patients scheduled for major surgical procedures that will require aspirin discontinuation
  • Patients with contraindication of aspirin
  • Patients expected to have a prognosis of 1 year or less due to comorbidities
  • Women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization
  • Patients who are judged by attending physicians to be inappropriate to participate in this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Japan · 1 center
  • Kyoto University Hospital — Kyoto

Identifiers

NCT: NCT05347069 · Y0126

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗