Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization
ASA-IN
1 other identifier
interventional
2,890
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety aspirin in patients with chronic coronary syndromes without revascularization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2022
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
March 11, 2025
March 1, 2025
7.7 years
April 21, 2022
March 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite cardiovascular events
Composite of all-cause death, myocardial infarction, ischemic stroke, coronary revascularization, peripheral revascularization, or critical limb ischemia
5 years
Secondary Outcomes (12)
All-cause death
5 years
Myocardial infarction
5 years
Ischemic stroke
5 years
Coronary revascularization
5 years
Peripheral revascularization
5 years
- +7 more secondary outcomes
Study Arms (2)
Aspirin
ACTIVE COMPARATORAspirin 100 mg/day
No Aspirin
ACTIVE COMPARATORNo Aspirin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takeshi Morimotolead
Study Sites (1)
Kyoto University Hospital
Kyoto, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Takeshi Kimura, MD, PhD
Kyoto University, Graduate School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Study Statistician
Study Record Dates
First Submitted
April 21, 2022
First Posted
April 26, 2022
Study Start
June 14, 2022
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
March 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share