Evaluating aspirin's effectiveness in patients with chronic coronary syndromes who can't undergo revascularization
Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization
PHASE4 · Kyoto University, Graduate School of Medicine · NCT05347069
This study is testing whether aspirin can help people with chronic coronary syndromes who can't have surgery to improve their heart health.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2890 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Kyoto University, Graduate School of Medicine (other) |
| Locations | 1 site (Kyoto) |
| Trial ID | NCT05347069 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of aspirin in patients diagnosed with chronic coronary syndromes who are not candidates for revascularization procedures. It is a multicenter, randomized, open-label trial that will compare outcomes between patients receiving aspirin and those not receiving it. The study addresses a gap in current knowledge regarding the use of aspirin for secondary prevention in this specific patient population, as previous research has primarily focused on other groups. By evaluating the impact of aspirin on cardiovascular events and safety in these patients, the study seeks to provide valuable insights into its potential benefits.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with chronic coronary syndromes who have significant coronary artery stenosis but are not eligible for revascularization.
Not a fit: Patients who have a history of acute coronary syndromes or those who are already on mandatory antithrombotic therapy other than aspirin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for the use of aspirin as a preventive treatment in patients with chronic coronary syndromes, potentially improving their cardiovascular outcomes.
How similar studies have performed: While aspirin has been established for acute coronary syndromes, this specific approach in chronic coronary syndromes without revascularization is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kyoto
- Kyoto University Hospital — Kyoto, Japan (RECRUITING)
Study contacts
- Principal investigator: Takeshi Kimura, MD, PhD — Kyoto University, Graduate School of Medicine
- Study coordinator: Takeshi Kimura, MD, PhD
- Email: taketaka@kuhp.kyoto-u.ac.jp
- Phone: +81-75-751-4255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stable Angina Pectoris, Coronary Artery Disease, Ischemic Heart Disease, Chronic Coronary Syndrome, Aspirin