NCT07374718Not yet recruiting
Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk
Optimization and Verification of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy: Safety and Efficacy of De-escalation Dual Antiplatelet Therapy in Moderate-to-high Ischemic Risk and High Bleeding Risk ACS Patients After BioFreedom™ Drug-Coated Coronary Stenting
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 468 (estimated)
- First submitted
- 20 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Shenyang Northern Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07374718
What you commit to
- Study type: Interventional
- Planned participants: 468
- From 1 Mar 2026 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients planning to undergo surgical intervention within 12 months
Other illness
- Patients with known allergy or contraindication to P2Y12 inhibitors, aspirin, or contrast agents
- Patients with a history of substance abuse (alcohol, cocaine, heroin, etc.), or with an expected life expectancy of less than 1 year
Lab values
- Left Ventricular Ejection Fraction (LVEF) \< 35%
Other
- Patients with contraindications to PCI
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.