Sirolimus With corTicOsteroid TheraPy for Rapid rEcurrences of Coronary Unexplained In-stent Restenosis
NCT06981845 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2025-05-21
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))
Interventions
- DRUG
-
Immunosuppressive therapy
prednisone + sirolimus
- DRUG
-
Placebo
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences, Fuwai Hospital
collaborator OTHER -
The First Hospital of Jilin University
collaborator OTHER -
China National Center for Cardiovascular Diseases
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2028-06-01
- Completion
- 2028-06-01
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