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

NCT06981845 | Not Yet Recruiting DMC

• 1 other identifier: 2025-2645
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  During the 1 year follow-up

Study Arms (2)

Immunosuppressive therapy group

EXPERIMENTAL

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

Drug: Immunosuppressive therapy

placebo control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Immunosuppressive therapy DRUG

prednisone + sirolimus

Immunosuppressive therapy group

Placebo DRUG

Placebo

placebo control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• The First Hospital of Jilin University: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Interventions

Immunosuppression Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share