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Not yet recruitingNCT06981845STOP-RECURUpdated May 21, 2025

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

An interventional study of Immunosuppressive therapy and Placebo in In-stent Restenosis Lesion and Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

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

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Immunosuppressive therapy group

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

    Drug: Immunosuppressive therapy

  • Placebo comparator
    placebo control group

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

    Drug: Placebo

Interventions

  • DrugImmunosuppressive therapy

    prednisone + sirolimus

  • DrugPlacebo

    Placebo

05

What researchers measure

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.

    Time frame: During the 1 year follow-up

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06981845
Lead sponsor
China National Center for Cardiovascular Diseases
Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital, The First Hospital of Jilin University
Responsible party
Kefei Dou, MD (Professor, China National Center for Cardiovascular Diseases) — Principal investigator
First posted
May 21, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
May 21, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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