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Compares treatment options for Coronary Artery Disease
Official title Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent
ClinicalTrials.gov ID: NCT05418556
What this study is testing
What is aspirin?
aspirin is an investigational medicine, being studied as a potential treatment for coronary artery disease.
Also referred to as clopidogrel, prasugrel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bucheon-si, South Korea
- Busan, South Korea
- Changwon, South Korea
- Chuncheon, South Korea
- Chungju, South Korea
- Daegu, South Korea
- Daejeon, South Korea
- Gangneung, South Korea
- Hwaseong-si, South Korea
- Ilsan, South Korea
- Jeju City, South Korea
- Jeonju, South Korea
- Jinju, South Korea
- Jungnam, South Korea
- Seoul, South Korea
- Suwon, South Korea
- Uijeongbu-si, South Korea
- Ulsan, South Korea
- Yangsan, South Korea
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bucheon-si, South Korea; Busan, South Korea; Changwon, South Korea; Chuncheon, South Korea; Chungju, South Korea; Daegu, South Korea and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.