Sirolimus With corTicOsteroid TheraPy for Rapid rEcurrences of Coronary Unexplained In-stent Restenosis

NCT06981845 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-05-21

No results posted yet for this study

Summary

This study aims to evaluate, through a multicenter, prospective, double-blind, randomized, placebo-controlled clinical trial, whether immunosuppressive therapy improves target lesion-related cardiovascular outcomes compared to placebo treatment in patients with Rapid rEcurrence of Coronary Unexplained in-stent Restenosis (RECUR).

Conditions

  • In-stent Restenosis Lesion
  • Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Interventions

DRUG

Immunosuppressive therapy

prednisone + sirolimus

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER
  • The First Hospital of Jilin University

    collaborator OTHER
  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2028-06-01
Completion
2028-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06981845 on ClinicalTrials.gov