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Not yet recruiting NCT06981845

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

No phase Interventional In-stent Restenosis Lesion Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immunosuppressive therapy, Placebo.
Who it may be relevant to
Registry conditions: In-stent Restenosis Lesion, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sirolimus With corTicOsteroid TheraPy for Rapid rEcurrences of Coronary Unexplained In-stent Restenosis (STOP-RECUR) Study

Overview

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).

Interventions

  • Drug Immunosuppressive therapy
    prednisone + sirolimus
  • Drug Placebo
    Placebo

Primary outcome measures

  • Target vessel failure (TVF) [Time frame: During the 1 year follow-up]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old
  • Able to understand the trial design and sign an informed consent form
  • Patients meeting the RECUR definition
  • Satisfactory results from revascularization within the past two weeks
  • Receiving standard secondary prevention medication for coronary heart disease with treatment targets achieved

Exclusion criteria

Pregnant women, individuals known to be allergic to the study drug, those currently participating in other interventional clinical trials, or participants deemed unsuitable for this study based on the investigator's judgment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06981845 · 2025-2645 · 2025-2645

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗