Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06855537 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2025 to Nov 3, 2025
    • Site details revised
    v4
  2. Notable Start date: Oct 1, 2025 to Dec 1, 2025
    • Eligibility criteria expanded, about 11 words
    v3
  3. Notable Start date: Mar 1, 2025 to Oct 1, 2025v2 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Interventions: OMT strategy (Drug), PCI/PTCA strategy (Procedure) to OMT strategy (Drug), PCI strategy (Procedure)
    • Eligibility criteria expanded, about 94 words
    • Secondary endpoints: 8 to 10
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06855537
Lead Sponsor Beijing Anzhen Hospital
Conditions
(from sponsor)
Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Thin-cap fIbroatheroma, Acute Coronary Syndromes (ACS)
Related terms Acute Coronary Syndrome
Enrollment 2,190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov