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

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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorChina National Center for Cardiovascular Diseases

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Immunosuppressive therapy
Drug
prednisone + sirolimus
Placebo
Drug
Placebo

Treatment groups

52 Participants

are divided into 2 treatment groups

Group A: Immunosuppressive therapy groupExperimental treatment 1 intervention

Group B: placebo control groupPlacebo comparator 1 intervention

Trial 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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

The First Hospital of Jilin University