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

N/ANot Yet RecruitingNCT06981845

China National Center for Cardiovascular Diseases52 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

Immunosuppressive therapyDRUG

prednisone + sirolimus

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years old 2. Able to understand the trial design and sign an informed consent form 3. Patients meeting the RECUR definition 4. Satisfactory results from revascularization within the past two weeks 5. 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.

Outcomes

Primary Outcomes

Target vessel failure (TVF)

Time to first occurrence of Target vessel failure (TVF), defined as cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.

Time frame: During the 1 year follow-up

Data from ClinicalTrials.gov

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