NCT06855537 Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
| NCT ID | NCT06855537 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beijing Anzhen Hospital |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,190 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,190 participants in total. It began in 2025-11-03 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is: Can interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy? Researchers will randomly assign patients who meet the inclusion criteria to preventative intervention plus optimal drug therapy (experimental group) or optimal drug therapy alone (control group). Participants will: Assigned to the control group: optimized drug therapy consisting of lifestyle improvement and intensive drug therapy including high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol \<1.4 mmol/L and decreased by 50% compared to the baseline). Lifestyle improvement and risk factor management included smoking cessation, nutritional optimization, physical activity, compliance with prescribed medications, and control of diabetes and hypertension. Assigned to the experimental group: all non-flow-limiting vulnerable plaques were treated with conventional second-generation drug-eluting stents. After the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.
Eligibility Criteria
Inclusion Criteria Clinical Inclusion Criteria 1. Males or non-pregnant females aged 18-80 years 2. Clinically diagnosed with acute coronary syndrome (including unstable angina, ST-segment elevation myocardial infarction, and non-ST-segment elevation myocardial infarction) 3. Patients willing and able to sign a written informed consent form Angiography, QFR, and OCT Inclusion Criteria 1. Successful completion of angiography, QFR, and OCT examinations 2. Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8) 3. Reference vessel diameter between 2.5-4.0 mm on imaging assessment 4. Lesion length ≤40 mm 5. At least one significant stenosis (diameter reduction \>50%) demonstrated by angiography, with QFR \>0.80 and OCT-defined TCFA (fibrous cap thickness \<65μm, lipid arc \>90°) Exclusion Criteria Clinical Exclusion Criteria 1. Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year 2. Patients with other major illnesses and a life expectancy \<2 years 3. Patients scheduled for cardiac surgery or major non-cardiac surgery 4. Women who are breastfeeding, pregnant, or planning pregnancy during the study 5. Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction \<35%) 6. Patients with estimated glomerular filtration rate \<30 mL/(min·1.73 m²) 7. Patients with allergy to contrast agents or DES drugs 8. Patients currently enrolled in other clinical studies Angiographic Exclusion Criteria 1\. Patients for whom CABG is the preferred treatment 2. Target lesion is a previously stented lesion 3. Target lesion is a post-bypass lesion 4. Target lesion is a heavily calcified or angulated lesion 5. Target lesion requires dual-stent technique 6. Target lesion is a left main coronary artery lesion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06855537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06855537 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06855537 currently recruiting?
Yes, NCT06855537 is actively recruiting participants. Contact the research team at shiboqun@126.com for enrollment information.
Where is the NCT06855537 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06855537 clinical trial?
NCT06855537 is sponsored by Beijing Anzhen Hospital. The trial plans to enroll 2,190 participants.