Clinical trial NCT05347069: Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization
Official title: Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Stable Angina Pectoris
Coronary Artery Disease
Ischemic Heart Disease
Keywords: Chronic Coronary Syndrome
Aspirin
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 2890
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Composite cardiovascular events
timeFrame: 5 years
Secondary outcomes:
measure: All-cause death
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 5 years
measure: Ischemic stroke
timeFrame: 5 years
measure: Coronary revascularization
timeFrame: 5 years
measure: Peripheral revascularization
timeFrame: 5 years
measure: Critical limb ischemia
timeFrame: 5 years
measure: Cardiovascular death
timeFrame: 5 years
measure: Major bleeding
timeFrame: 5 years
measure: Hospital admission for heart failure
timeFrame: 5 years
measure: Cancer incidence
timeFrame: 5 years
measure: Cancer death
timeFrame: 5 years
measure: 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
timeFrame: 5 years
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Takeshi Kimura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: