Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent

Coronary Artery Disease Clinical Trial

— OPTIMIZE-APT  

Official title:

Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418556
• Other study ID #: 2022-0568
• Status: Recruiting
• Phase: Phase 4
• Start date: October 21, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Asan Medical Center
• Contact: Ji Sue Hong, RN
• Phone: 82 2-2045-3798
• Email: sue5165[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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: 1. Clinically relevant bleeding (BARC 2, 3, or 5) at 12 months post-PCI 2. Ischemic composite adverse events of all-cause death, MI, ischemia-driven TVR, stent thrombosis at 12 months post-PCI 3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3944
• Est. completion date: December 31, 2028
• Est. primary completion date: August 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Men or women =19 years

2. Typical chest pain or objective evidence of myocardial ischemia suitable for PCI

3. Significant de novo coronary artery lesions suitable for DES implantation

4. 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%

5. 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:

1. 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.

2. In-stent restenosis

3. 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.

4. Persistent thrombocytopenia (platelet count <80,000/l)

5. Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months

6. A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin

7. Patients requiring long-term oral anticoagulants or cilostazol

8. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.

9. 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.

10. 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.

11. History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction

12. Life expectancy < 1 years for any non-cardiac or cardiac causes

13. Cardiogenic shock at the index admission

14. Patient's pregnant or breast-feeding

15. 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)

16. Unwillingness or inability to comply with the procedures described in this protocol.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• aspirin
DAPT strategy

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Sejong Hospital	Bucheon
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Chungbuk National University Hospital	Chungju
Korea, Republic of	Chungnam National University Sejong Hospital	Chungnam
Korea, Republic of	Dankook University Hospital	Chungnam
Korea, Republic of	Daegu Catholic Univ Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Veterans Hospital	Daegu
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Jeonbuk National University Hospital	Jeonju
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul
Korea, Republic of	Veterans Hospital Service Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]	1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]	12 month
Primary	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]	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]	12 month
Primary	3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)	3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)	12 month
Secondary	1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)	1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)	12 month
Secondary	2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group	2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group	1 or 3 month