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Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent (OPTIMIZE-APT)

Primary Purpose

Coronary Artery Disease

Status

Recruiting

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

aspirin

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

Men or women ≥18 years
Typical chest pain or objective evidence of myocardial ischemia suitable for PCI
Significant de novo coronary artery lesions suitable for DES implantation
Patients who underwent optimized stent implantation either by IVUS or OCT
The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion Criteria:

Angiographic exclusion criteria: any of the followings 1. Bypass graft lesions 2. Lesions in which impaired delivery of imaging catheters is expected:
- Extreme angulation (≥90°) proximal to or within the target lesion.
- Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
- Heavy calcification proximal to or within the target lesion.
In-stent restenosis
Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
Persistent thrombocytopenia (platelet count <80,000/l)
Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months
A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin
Patients requiring long-term oral anticoagulants or cilostazol
Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction
Life expectancy < 1 years for any non-cardiac or cardiac causes
Cardiogenic shock at the index admission
Patient's pregnant or breast-feeding
Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
Unwillingness or inability to comply with the procedures described in this protocol.

Sites / Locations

Bucheon Sejong Hospital
Dong-A University Hospital
Inje University Busan Paik Hospital
Kosin University Gospel Hospital
Gyeongsang National University Changwon Hospital
Kangwon National University Hospital
Chungbuk National University Hospital
Chungnam National University Sejong Hospital
Daegu Catholic Univ Medical Center
Keimyung University Dongsan Medical Center
Veterans Hospital
Gangneung Asan Hospital
Jeonbuk National University Hospital
Gyeongsang National University Hospital
Asan Medical CenterRecruiting
Kangbuk Samsung Hospital
Korea University Anam Hospital
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Veterans Hospital Service Medical Center
Ajou University Hospital
The Catholic University of Korea, ST. Vincent's Hospital
Ulsan University Hospital
Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Arm

Tailored Arm

Arm Description

After PCI, patients are prescribed aspirin at a daily dose of 100 mg PO plus a P2Y12 inhibitor [clopidogrel or ticagrelor or prasugrel according to the clinical diagnosis] for 12 months after the index PCI.

The antiplatelet regimens post-PCI are 1-month DAPT (aspirin plus clopidogrel) followed by 11-months clopidogrel alone for CCS, and 3-months DAPT (aspirin plus P2Y12 inhibitor [ticagrelor, prasugrel]) followed by 9-months P2Y12 inhibitor alone for ACS.

Outcomes

Primary Outcome Measures

1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]

2) net clinical outcome defined as a composite of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding [BARC 2, 3, or 5]

3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)

Secondary Outcome Measures

1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)

2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group

Full Information

NCT ID

NCT05418556

First Posted

June 7, 2022

Last Updated

June 13, 2023

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05418556

Brief Title

Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent

Acronym

OPTIMIZE-APT

Official Title

Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 21, 2022 (Actual)

Primary Completion Date

August 30, 2027 (Anticipated)

Study Completion Date

December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Objectives: To assess the safety of tailored antiplatelet therapy (short DAPT followed by P2Y12 inhibitor alone strategy) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT) Hypothesis: Tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) is superior to conventional antiplatelet strategy in terms of clinically relevant bleeding and noninferior for ischemic composite adverse events in patients who received intravascular imaging-guided optimized DES implantation. (Optimized stent evaluated by on-site IVUS/OCT could act as an essential criterion for decision making for tailored antithrombotic strategy)

Detailed Description

Objective: To assess the safety of tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT) Design: Prospective, open label, multi-center, dual arm, randomized trial Number of Subjects 3,944 subjects (1972:1972) Study Population: Patients with coronary artery disease undergoing imaging-guided PCI Study Design: Eligible subjects will be randomized 1:1 to a) conventional DAPT strategy or b) tailored anti-platelet strategy (short DAPT followed by P2Y12 inhibitor alone) after optimized DES implantation guided by intravascular imaging. All subjects will be clinically followed at 1, 6, and 12 months Co-primary Endpoints: Clinically relevant bleeding (BARC 2, 3, or 5) at 12 months post-PCI Ischemic composite adverse events of all-cause death, MI, ischemia-driven TVR, stent thrombosis at 12 months post-PCI Net clinical outcome (NACE) of all-cause death, MI, ischemia-driven TVR, stent thrombosis, BARC 2,3,5 bleeding at 12 months post-PCI Statistics and Analysis: The study was designed to test the hypothesis that tailored antithrombotic strategy, as compared to the conventional DAPT, would be superior for clinically relevant bleeding, noninferior to the ischemic composite adverse events and NACE. The primary analysis would be evaluated by intention-to-treat analysis. With 3756 (each 1,878) patients, this study has >80% power to detect noninferiority of tailored antiplatelet strategy for ischemic composite adverse event, >85% power to detect noninferiority of tailored antiplatelet strategy for NACE, and >85% power to detect superiority of the tailored antiplatelet arm on clinically relevant bleeding. To compensate for 5% attrition rate, 3,944 (each 1,972) patients will be randomized.

6. Conditions and Keywords

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

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Eligible subjects will be randomized 1:1 to a) conventional DAPT strategy or b) tailored anti-platelet strategy (short DAPT followed by P2Y12 inhibitor alone) after optimized DES implantation guided by intravascular imaging. All subjects will be clinically followed at 1, 6, and 12 months

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3944 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional Arm

Arm Type

Active Comparator

Arm Description

Arm Title

Tailored Arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

aspirin

Other Intervention Name(s)

clopidogrel, prasugrel, ticagrelor

Intervention Description

DAPT strategy

Primary Outcome Measure Information:

Title

1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]

Description

1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]

Time Frame

12 month

Title

Description

Time Frame

12 month

Title

3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)

Description

3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)

Time Frame

12 month

Secondary Outcome Measure Information:

Title

1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)

Description

1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)

Time Frame

12 month

Title

2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group

Description

2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group

Time Frame

1 or 3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men or women ≥18 years Typical chest pain or objective evidence of myocardial ischemia suitable for PCI Significant de novo coronary artery lesions suitable for DES implantation Patients who underwent optimized stent implantation either by IVUS or OCT Using IVUS MSA >5.5 mm2, or MSA >90% of the MLA at the distal reference segment Plaque burden <50% with 5 mm of both stent edge No edge dissection, thrombus or plaque protrusion/stent area <10% Using OCT MSA >4.5 mm2, or MSA >90% of the MLA at the distal reference segment No significant malapposition No significant edge dissection, thrombus or plaque protrusion/stent area <10% The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site Exclusion Criteria: Angiographic exclusion criteria: any of the followings 1. Bypass graft lesions 2. Lesions in which impaired delivery of imaging catheters is expected: Extreme angulation (≥90°) proximal to or within the target lesion. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion. Heavy calcification proximal to or within the target lesion. In-stent restenosis Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Persistent thrombocytopenia (platelet count <80,000/l) Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin Patients requiring long-term oral anticoagulants or cilostazol Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction Life expectancy < 1 years for any non-cardiac or cardiac causes Cardiogenic shock at the index admission Patient's pregnant or breast-feeding Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding) Unwillingness or inability to comply with the procedures described in this protocol.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ji Sue Hong, RN

Phone

82 2-2045-3798

sue5165@naver.com

First Name & Middle Initial & Last Name or Official Title & Degree

Seung-Whan Lee, MD

Phone

82 2-3010-3170

seungwlee@amc.seoul.kr

Facility Information:

Facility Name

Bucheon Sejong Hospital

City

Bucheon

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ha Wook Park, MD

First Name & Middle Initial & Last Name & Degree

Ha Wook Park, MD

Facility Name

Dong-A University Hospital

City

Busan

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yong Rak Cho, MD

First Name & Middle Initial & Last Name & Degree

Yong Rak Cho, MD

Facility Name

Inje University Busan Paik Hospital

City

Busan

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tae Hyun Yang, MD

First Name & Middle Initial & Last Name & Degree

Tae Hyun Yang, MD

Facility Name

Kosin University Gospel Hospital

City

Busan

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeong Ho Heo, MD

First Name & Middle Initial & Last Name & Degree

Jeong Ho Heo, MD

Facility Name

Gyeongsang National University Changwon Hospital

City

Changwon

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jae Seok Bae, MD

First Name & Middle Initial & Last Name & Degree

Jae Seok Bae, MD

Facility Name

Kangwon National University Hospital

City

Chuncheon

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bong Ki Lee, MD

First Name & Middle Initial & Last Name & Degree

Bong Ki Lee, MD

Facility Name

Chungbuk National University Hospital

City

Chungju

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang Min Kim, MD

First Name & Middle Initial & Last Name & Degree

Sang Min Kim, MD

Facility Name

Chungnam National University Sejong Hospital

City

Chungnam

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jae Hwan Lee, MD

First Name & Middle Initial & Last Name & Degree

Jae Hwan Lee, MD

Facility Name

Daegu Catholic Univ Medical Center

City

Daegu

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Bae Lee, MD

First Name & Middle Initial & Last Name & Degree

Jin Bae Lee, MD

Facility Name

Keimyung University Dongsan Medical Center

City

Daegu

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seung Ho Hur, MD

First Name & Middle Initial & Last Name & Degree

Seung Ho Hur, MD

Facility Name

Veterans Hospital

City

Daegu

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang Wook Kang, MD

First Name & Middle Initial & Last Name & Degree

Sang Wook Kang, MD

Facility Name

Gangneung Asan Hospital

City

Gangneung

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Han Bit Park, MD

First Name & Middle Initial & Last Name & Degree

Han Bit Park, MD

Facility Name

Jeonbuk National University Hospital

City

Jeonju

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang Rok Lee, MD

First Name & Middle Initial & Last Name & Degree

Sang Rok Lee, MD

Facility Name

Gyeongsang National University Hospital

City

Jinju

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Sin Koh, MD

First Name & Middle Initial & Last Name & Degree

Jin Sin Koh, MD

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seung-Whan Lee, MD

seungwlee@amc.seoul.kr

First Name & Middle Initial & Last Name & Degree

Seung-Whan Lee, MD

First Name & Middle Initial & Last Name & Degree

Pil Hyung Lee, MD

First Name & Middle Initial & Last Name & Degree

Tae Oh Kim, MD

Facility Name

Kangbuk Samsung Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jong Young Lee, MD

First Name & Middle Initial & Last Name & Degree

Jong Young Lee, MD

Facility Name

Korea University Anam Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Soon Jun Hong, MD

First Name & Middle Initial & Last Name & Degree

Soon Jun Hong, MD

Facility Name

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pum Joon Kim, MD

First Name & Middle Initial & Last Name & Degree

Pum Joon Kim, MD

Facility Name

Veterans Hospital Service Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chang Hoon Lee, MD

First Name & Middle Initial & Last Name & Degree

Chang Hoon Lee, MD

Facility Name

Ajou University Hospital

City

Suwon

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Myeong Ho Yoon, MD

First Name & Middle Initial & Last Name & Degree

Myeong Ho Yoon, MD

Facility Name

The Catholic University of Korea, ST. Vincent's Hospital

City

Suwon

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sung Ho Hur, MD

First Name & Middle Initial & Last Name & Degree

Sung Ho Hur, MD

Facility Name

Ulsan University Hospital

City

Ulsan

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gyung Min Park, MD

First Name & Middle Initial & Last Name & Degree

Gyung Min Park, MD

Facility Name

Pusan National University Yangsan Hospital

City

Yangsan

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kook Jin Chun, MD

First Name & Middle Initial & Last Name & Degree

Kook Jin Chun, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent

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