Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS … (NCT07374718) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk
China468 participantsStarted 2026-03-01
Plain-language summary
Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy (DAPT) may reduce ischemic events but increases bleeding complications.This prospective, multicenter, randomized controlled study evaluates the safety and effectiveness of an optimized PCI and antiplatelet therapy strategy in ACS patients with moderate-to-high ischemic risk and high bleeding risk. Eligible patients will be randomized in a 1:1 ratio to either an experimental strategy consisting of intravascular ultrasound-guided implantation of a polymer-free drug-coated stent followed by one month of DAPT and subsequent single antiplatelet therapy, or a control strategy consisting of angiography-guided implantation of contemporary drug-eluting stents followed by standard 12-month DAPT.The primary hypothesis is that the experimental strategy will reduce the incidence of net adverse clinical events, defined as a composite of ischemic and bleeding outcomes, compared with conventional PCI and prolonged DAPT. Participants will be followed for 12 months after the index procedure.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged ≥ 18 years old
* ACS patients with high bleeding risk (meeting the ARC-HBR criteria)
* Moderate-to-high ischemic risk (OPT-CAD score ≥ 90)
* Predicted by the investigator to be able to tolerate 12 months of DAPT
* Voluntarily participate and sign the informed consent form, and be willing to receive the designated follow-up of this trial at specific time points
* Coronary artery lesions are primary and in-situ coronary artery lesions
* Target lesion diameter stenosis ≥ 70% or ≥ 50% (visual estimation) accompanied by evidence of myocardial ischemia
Exclusion Criteria:
* Patients with known allergy or contraindication to P2Y12 inhibitors, aspirin, or contrast agents
* Patients planning to undergo surgical intervention within 12 months
* Left Ventricular Ejection Fraction (LVEF) \< 35%
* Patients with contraindications to PCI
* Patients with a history of substance abuse (alcohol, cocaine, heroin, etc.), or with an expected life expectancy of less than 1 year
* Subjects with poor compliance or judged by the investigator to be unsuitable for participating in the study
* Female patients who are planning to be pregnant or are pregnant/lactating, and male patients planning to impregnate
* Chronic total occlusion lesions
* Lesions involving the left main coronary artery
* Severe calcified and tortuous lesions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for ACS patients who have both moderate-to-high ischemic risk AND high bleeding risk — can you help me understand whether my situation fits both of those categories, and what that means for my treatment options?
2The trial is testing a 'de-escalation' approach to dual antiplatelet therapy after getting a BioFreedom stent — can you explain what de-escalation means in practice, how it differs from standard DAPT, and whether that kind of strategy might or might not make sense for me?
3Since this trial hasn't started recruiting yet, what would my treatment look like right now if I need a stent placed before this study opens, and is there an established standard of care for someone in my situation in the meantime?
4The trial is tracking something called Net Adverse Clinical Events over 12 months — can you walk me through what events that includes, like both clotting and bleeding complications, so I understand what risks are being weighed against each other here?
5Because this study is listed as Phase NA, which often applies to device or strategy trials rather than drug trials, what does that mean for how much safety and effectiveness data already exists for the BioFreedom stent and the de-escalation approach being tested?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The 12-month incidence of Net Adverse Clinical Events (NACE)