New combo therapy aims to halt rapid heart disease progression in inflamed arteries
NCT ID NCT05860400
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a comprehensive treatment plan can reduce heart attacks and other serious events in people with rapidly-progressive coronary artery disease tied to inflammation. Researchers will compare each participant's outcomes before and after treatment. The study enrolls 39 adults who have already had heart procedures like stents or bypass surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All patients who were admitted to the Department of Cardiology, Peking Union Medical College Hospital on and after January 1, 2022 will be screened for study participation.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Fulfilling all the following criteria before initiation of comprehensive treatment: 1.1 18 years of age or older, male or female. 1.2 Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile). 1.3 Prior history of coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]). 1.4 Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization. 1.5 Hospitalization due to rapidly-progressive myocardial ischemia: * Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and * Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization. 1.6 Angiographic evidence of new coronary lesions (de novo stenoses or restenoses): * Occurred after the last coronary revascularization; and * Related to myocardial ischemia (location, extent, severity, et al). 1.7 Evidence of inflammation: * At least one of the markers indicating active inflammation has ever been elevated (erythrocyte sedimentation rate \[ESR\], high-sensitivity C-reactive protein \[hs-CRP\], interleukin \[IL\]-6, tumor necrosis factor \[TNF\]-α, ferritin, et al); or * Established diagnosis of systemic autoimmune disease or systemic vasculitis; or * Receiving immunosuppressive therapy. 2. Receiving comprehensive treatment, including ischemia-driven PCI which was performed no earlier than 40 days of the initiation of immunosuppressive therapy. Exclusion Criteria: 1. Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al). 2. Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al). 3. Active acute or chronic infection (human immunodeficiency virus \[HIV\], tuberculosis, et al). 4. Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment). 5. Vital organ failure. 6. Life expectancy \< 1 year. 7. Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents. 8. In pregnancy or breast-feeding, or with intention to be pregnant during the study period. 9. Risk of non-compliance (history of drug addiction or alcohol abuse, et al). 10. Previous enrollment in this study. 11. Participation in another study within 30 days. 12. Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al). 13. Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
RECRUITINGBeijing, Beijing Municipality, 100730, China
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