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A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial

Primary Purpose

Coronary Artery Disease, DES

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Clopidogrel mono-therapy

Dual-antiplatelet therapy

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Patients who underwent percutaneous coronary intervention with DES implantation carrying high risks for the recurrent major adverse events., anti platelet therapy, bleeding

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients >19 years old
Patients who underwent DES implantation 12 months (+5 months) previously.
High risk characteristics (clinical or lesion) for ischemic events (must at least one)

High risk patients; clinical criteria

Acute coronary syndrome
Previous history of cerebrovascular accidents
History of peripheral artery intervention
Heart failure (left ventricular ejection fraction ≤40%)
Diabetes treated with medication
Chronic renal insufficiency including end-stage renal diseases

High risk lesions; angiographic or procedural criteria

Left main diseases
Bifurcation lesions
Chronic total occlusion
In-stent restenotic lesions
Graft lesions
Diffuse long lesions requiring total stent length ≥28 mm
Calcified lesions requiring atherectomy
Multivessel coronary artery disease with multiple stents
Small vessel disease requiring stent diameter of ≤2.5 mm

Exclusion Criteria:

Age> 80 years
Pregnant women or women with potential childbearing
Life expectancy < 1 year
Refusal or inability to understand of informed consent

Sites / Locations

Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South KoreaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Clopidogrel mono-therapy

Dual-antiplatelet therapy

Arm Description

After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months.

Patients will receive dual antiplatelet consisting of aspirin and clopidogrel.

Outcomes

Primary Outcome Measures

Net Adverse Clinical Events (NACE)

The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5)

Secondary Outcome Measures

Each component of net adverse clinical events

All-cause or cardiovascular mortality

Major or minor bleeding

Major or minor bleeding would be defined by BARC and TIMI criteria

Major adverse cardiac event

Major Adverse Cardiac events includes all-cause of death, myocardial infarctions, stent thrombosis, or stroke.

Full Information

NCT ID

NCT03947229

First Posted

May 8, 2019

Last Updated

August 21, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03947229

Brief Title

A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial

Official Title

A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 14, 2019 (Actual)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.

Detailed Description

Patients at high risk for either ischemic or bleeding complications, but who were stable without clinical events for 12 months after DES implantation will be included in this study. Eligible patients will be randomized to continue DAPT (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). Randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or <75). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative. All of study subjects will be have an outpatient visit as scheduled in outpatient clinic. Occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months since randomization. Antiplatelet drugs will be open-label and prescribed by attending physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, DES

Keywords

Patients who underwent percutaneous coronary intervention with DES implantation carrying high risks for the recurrent major adverse events., anti platelet therapy, bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Patients will be assigned to continue DAPT (aspirin plus clopidogrel) or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone) for further 24 months.

Masking

None (Open Label)

Masking Description

Antiplatelet drugs will be open-label and prescribed by attending physician.

Allocation

Randomized

Enrollment

3200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clopidogrel mono-therapy

Arm Type

Active Comparator

Arm Description

After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months.

Arm Title

Dual-antiplatelet therapy

Arm Type

Active Comparator

Arm Description

Patients will receive dual antiplatelet consisting of aspirin and clopidogrel.

Intervention Type

Drug

Intervention Name(s)

Clopidogrel mono-therapy

Intervention Description

Patients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization.

Intervention Type

Drug

Intervention Name(s)

Dual-antiplatelet therapy

Intervention Description

Patients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization.

Primary Outcome Measure Information:

Title

Net Adverse Clinical Events (NACE)

Description

The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5)

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Each component of net adverse clinical events

Time Frame

24 months

Title

All-cause or cardiovascular mortality

Time Frame

24 months

Title

Major or minor bleeding

Description

Major or minor bleeding would be defined by BARC and TIMI criteria

Time Frame

24 months

Title

Major adverse cardiac event

Description

Major Adverse Cardiac events includes all-cause of death, myocardial infarctions, stent thrombosis, or stroke.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients >19 years old Patients who underwent DES implantation 12 months (+5 months) previously. High risk characteristics (clinical or lesion) for ischemic events (must at least one) High risk patients; clinical criteria Acute coronary syndrome Previous history of cerebrovascular accidents History of peripheral artery intervention Heart failure (left ventricular ejection fraction ≤40%) Diabetes treated with medication Chronic renal insufficiency including end-stage renal diseases High risk lesions; angiographic or procedural criteria Left main diseases Bifurcation lesions Chronic total occlusion In-stent restenotic lesions Graft lesions Diffuse long lesions requiring total stent length ≥28 mm Calcified lesions requiring atherectomy Multivessel coronary artery disease with multiple stents Small vessel disease requiring stent diameter of ≤2.5 mm Exclusion Criteria: Age> 80 years Pregnant women or women with potential childbearing Life expectancy < 1 year Refusal or inability to understand of informed consent

Facility Information:

Facility Name

Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Byeong-Keuk Kim, PhD

Phone

82-2-2228-8460

kimbk@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial

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