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

National Center for Cardiovascular Diseases

Status: Not yet enrolling

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

Treatments: Drug: Placebo; Drug: Immunosuppressive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06981845

2025-2645 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Immunosuppressive therapy group

Experimental group

Description:

(1) prednisone + sirolimus and (2) standard coronary artery disease therapy

Treatment:

Drug: Immunosuppressive therapy

placebo control group

Placebo Comparator group

Description:

(1) placebo and (2) standard coronary artery disease therapy

Treatment:

Drug: Placebo