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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06981845

Acronym

STOP-RECUR

Enrollment

Registered

2025-05-21

Start date

2025-06-01

Completion date

2028-06-01

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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).

Interventions

DRUGImmunosuppressive therapy

prednisone + sirolimus

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Target vessel failure (TVF)	During the 1 year follow-up	Time to first occurrence of Target vessel failure (TVF), defined as cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026