Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Men or women ≥19 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

Locations
Other Locations
Republic of Korea
Bucheon Sejong Hospital
RECRUITING
Bucheon-si
Dong-A University Hospital
RECRUITING
Busan
Inje University Busan Paik Hospital
NOT_YET_RECRUITING
Busan
Kosin University Gospel Hospital
RECRUITING
Busan
Gyeongsang National University Changwon Hospital
RECRUITING
Changwon
Kangwon National University Hospital
RECRUITING
Chuncheon
Chungbuk National University Hospital
RECRUITING
Chungju
Daegu Catholic Univ Medical Center
NOT_YET_RECRUITING
Daegu
Keimyung University Dongsan Medical Center
RECRUITING
Daegu
Kyungpook National University Hospital
NOT_YET_RECRUITING
Daegu
Veterans Hospital
NOT_YET_RECRUITING
Daegu
Gangneung Asan Hospital
RECRUITING
Gangneung
Jeonbuk National University Hospital
RECRUITING
Jeonju
Gyeongsang National University Hospital
RECRUITING
Jinju
Chungnam National University Sejong Hospital
RECRUITING
Jungnam
Dankook University Hospital
RECRUITING
Jungnam
Asan Medical Center
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Veterans Hospital Service Medical Center
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
The Catholic University of Korea, ST. Vincent's Hospital
COMPLETED
Suwon
Ulsan University Hospital
RECRUITING
Ulsan
Pusan National University Yangsan Hospital
NOT_YET_RECRUITING
Yangsan
Contact Information
Primary
Ji Sue Hong, RN
sue5165@naver.com
82 2-2045-3798
Backup
Pil Hyung Lee, MD
pilmo11@hanmail.net
82 2-3010-3170
Time Frame
Start Date: 2022-10-21
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 3944
Treatments
Active_comparator: Conventional Arm
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.
Experimental: Tailored Arm
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.
Related Therapeutic Areas
Sponsors
Leads: Asan Medical Center

This content was sourced from clinicaltrials.gov