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Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization (ASA-IN)

Primary Purpose

Stable Angina Pectoris, Coronary Artery Disease, Ischemic Heart Disease

Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Aspirin
No aspirin
Sponsored by
Takeshi Morimoto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stable Angina Pectoris focused on measuring Chronic Coronary Syndrome, Aspirin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyoto University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aspirin

No Aspirin

Arm Description

Aspirin 100 mg/day

No Aspirin

Outcomes

Primary Outcome Measures

Composite cardiovascular events
Composite of all-cause death, myocardial infarction, ischemic stroke, coronary revascularization, peripheral revascularization, or critical limb ischemia

Secondary Outcome Measures

All-cause death
As classified by Academic Research Consortium (ARC) (Circulation. 2007;115:2344-2351). Cardiac Death: Any death due to proximate cardiac cause, unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease should be classified as cardiac. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Cancer related death: death from cancer cause
Myocardial infarction
As classified by Academic Research Consortium (ARC): However, the sensitivity is too high for the evaluation with Troponin of the peri-procedural MI, thus CKMB will be used.
Ischemic stroke
Ischemic stroke is defined as acute onset of a neurological deficit that persists for at least 24 hours and is the result of a disturbance of the cerebral circulation due to ischemia. Deficits that last ≤ 24 hours are due to transient ischemic neurological attack and are not classified in this category.
Coronary revascularization
The revascularization that meets the following criteria is considered as clinically indicated revascularization. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.
Peripheral revascularization
The revascularization that meets the following criteria is considered as clinically indicated revascularization. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.
Critical limb ischemia
Critical limb ischemia is defined by chronic ischemic pain at rest and/or presence of ischemic skin lesions (gangrene or ulcerations).
Cardiovascular death
Cardiac Death: Any death due to proximate cardiac cause (e.g. myocardial infarction [MI], low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Major bleeding
Bleeding/Hemorrhagic Complications will be evaluated using the Bleeding Academic Research Consortium (BARC) definition. Major bleeding is defined as BARC 3 or 5.
Hospital admission for heart failure
An unplanned hospitalization with heart failure. Heart failure is defined by the modified Framingham criteria as follow: [Major Criteria] 1) Paroxysmal nocturnal dyspnea 2) Orthopnea 3) Neck-vein distension 4) Rales 5) Acute pulmonary edema [Minor Criteria] Ankle edema Dyspnea on exertion Pleural effusion Tachycardia (HR ≧ 120/min) * For establishing a definite diagnosis of heart failure, 2 Major criteria or 1 major and 2 minor criteria must be present concurrently
Cancer incidence
Non-metastatic cancer (not present prior to randomization) Metastatic cancer (cancer that was metastatic at presentation, metastasis of a non-metastatic cancer presents at baseline, or blood cancer) Non-melanoma skin cancer was excluded cancer end points.
Cancer death
Cancer death is defined as death from cancer cause.
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
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

Full Information

First Posted
April 21, 2022
Last Updated
October 2, 2023
Sponsor
Takeshi Morimoto
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1. Study Identification

Unique Protocol Identification Number
NCT05347069
Brief Title
Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization
Acronym
ASA-IN
Official Title
Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
March 2030 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Takeshi Morimoto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris, Coronary Artery Disease, Ischemic Heart Disease
Keywords
Chronic Coronary Syndrome, Aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2890 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Aspirin 100 mg/day
Arm Title
No Aspirin
Arm Type
Active Comparator
Arm Description
No Aspirin
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 100 mg/day
Intervention Type
Drug
Intervention Name(s)
No aspirin
Intervention Description
No aspirin administered
Primary Outcome Measure Information:
Title
Composite cardiovascular events
Description
Composite of all-cause death, myocardial infarction, ischemic stroke, coronary revascularization, peripheral revascularization, or critical limb ischemia
Time Frame
5 years
Secondary Outcome Measure Information:
Title
All-cause death
Description
As classified by Academic Research Consortium (ARC) (Circulation. 2007;115:2344-2351). Cardiac Death: Any death due to proximate cardiac cause, unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease should be classified as cardiac. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Cancer related death: death from cancer cause
Time Frame
5 years
Title
Myocardial infarction
Description
As classified by Academic Research Consortium (ARC): However, the sensitivity is too high for the evaluation with Troponin of the peri-procedural MI, thus CKMB will be used.
Time Frame
5 years
Title
Ischemic stroke
Description
Ischemic stroke is defined as acute onset of a neurological deficit that persists for at least 24 hours and is the result of a disturbance of the cerebral circulation due to ischemia. Deficits that last ≤ 24 hours are due to transient ischemic neurological attack and are not classified in this category.
Time Frame
5 years
Title
Coronary revascularization
Description
The revascularization that meets the following criteria is considered as clinically indicated revascularization. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.
Time Frame
5 years
Title
Peripheral revascularization
Description
The revascularization that meets the following criteria is considered as clinically indicated revascularization. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.
Time Frame
5 years
Title
Critical limb ischemia
Description
Critical limb ischemia is defined by chronic ischemic pain at rest and/or presence of ischemic skin lesions (gangrene or ulcerations).
Time Frame
5 years
Title
Cardiovascular death
Description
Cardiac Death: Any death due to proximate cardiac cause (e.g. myocardial infarction [MI], low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Time Frame
5 years
Title
Major bleeding
Description
Bleeding/Hemorrhagic Complications will be evaluated using the Bleeding Academic Research Consortium (BARC) definition. Major bleeding is defined as BARC 3 or 5.
Time Frame
5 years
Title
Hospital admission for heart failure
Description
An unplanned hospitalization with heart failure. Heart failure is defined by the modified Framingham criteria as follow: [Major Criteria] 1) Paroxysmal nocturnal dyspnea 2) Orthopnea 3) Neck-vein distension 4) Rales 5) Acute pulmonary edema [Minor Criteria] Ankle edema Dyspnea on exertion Pleural effusion Tachycardia (HR ≧ 120/min) * For establishing a definite diagnosis of heart failure, 2 Major criteria or 1 major and 2 minor criteria must be present concurrently
Time Frame
5 years
Title
Cancer incidence
Description
Non-metastatic cancer (not present prior to randomization) Metastatic cancer (cancer that was metastatic at presentation, metastasis of a non-metastatic cancer presents at baseline, or blood cancer) Non-melanoma skin cancer was excluded cancer end points.
Time Frame
5 years
Title
Cancer death
Description
Cancer death is defined as death from cancer cause.
Time Frame
5 years
Title
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
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeshi Kimura, MD, PhD
Phone
+81-75-751-4255
Email
taketaka@kuhp.kyoto-u.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Yamamoto, MD, PhD
Phone
+81-75-751-4255
Email
erkymmt@kuhp.kyoto-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD, PhD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyoto University Hospital
City
Kyoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD, PhD
Phone
+81-75-751-4255
First Name & Middle Initial & Last Name & Degree
Erika Yamamoto, MD, PhD
Phone
+81-75-751-4255
Email
erkymmt@kuhp.kyoto-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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