In-stent RestenosisPhase 4NCT06090890
Anti-inflammatory Therapy for Recurrent In-stent Restenosis
A Phase 4 study testing Colchicine, Prednisone and Aspirin in people with In-stent Restenosis, run by Fu Wai Hospital, Beijing, China at 4 sites in China.
Trial summary
This study is aimed at making a comparison of the safety and efficacy of standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group) in patients with coronary heart disease who suffered from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-stent Restenosis
- What is being tested?
- Colchicine, Prednisone and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 4 sitesChina
- Study dates
- 30 Oct 2023to 29 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CAD patients over 18 years old;
- At least one coronary artery lesion meets the RISR criteria: target lesion ≥ 2 ISRs (stenosis of lumen diameter within the stent segment and within 5mm near and far of the stent ≥ 50%);
- Intended intervention treatment for RISR lesions;
- Acceptable for standard secondary prevention drug therapy for coronary heart disease, including dual antiplatelet therapy (DAPT) and statins;
- Willing to participate in the trial and complete follow-up, signing an informed consent form approved by the ethics committee
Who cannot join
- The previous interventional treatment situation is unknown;
- The mechanism of intracavitary imaging to clarify ISR is operator-related (poor stent adhesion, incomplete dilation, and stent fracture);
- Clearly diagnose vascular inflammatory diseases or connective tissue diseases (including arteritis, Behcet's disease, systemic lupus erythematosus, etc.) involving the coronary artery;
- Immunosuppressive drugs, including glucocorticoids, have been used in the past 30 days;
- There are contraindications to the use of prednisone or colchicine, including: serious infectious diseases, including active infection, hepatitis B, hepatitis C or AIDS patients; Hematological diseases, such as thrombocytopenia, severe anemia, leukemia, etc; Uncontrolled diabetes; Severe liver and kidney function damage; Active peptic ulcer or gastrointestinal bleeding; Severe osteoporosis (with previous pathological fractures); Inflammatory bowel disease or chronic diarrhea;
- A history of malignant tumors within 3 years;
- Cognitive impairment;
- Not willing to participate or follow up
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 10000
Haiyan Qian, MD, PhD, +86 17200376143, ahqhy712@163.com
- Not yet recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 10000
Ruifeng Liu, MD, fengziliu04@163.com
- Recruiting
Beijing Luhe Hospital
Beijing, Beijing Municipality, 10000
Ming Guo, MD, +86 15810975298, guoming2004_1999@Sina.com
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality
Haiyan Qian, MD, PhD, +86 13811386143, ahqhy712@163.com
About this study
Official title: Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis: a Prospective, Randomized, Open-label Trial
This study is aimed at making a comparison of the safety and efficacy of standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group) in patients with coronary heart disease who suffered from recurrent In-stent restenosis (RISR).
Read the detailed description
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. A total of 252 RISR patients are planned to be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group). The primary endpoint of the current study is target lesion ISR confirmed by coronary angiography for 12 months, and the secondary endpoint is Major adverse cardiovascular events (MACE: a composite of death, non-fatal myocardial infarction, non-fatal stroke, and target vascular revascularization) and each MACE component, target lesion revascularization, or other coronary artery disease revascularization for 12 months. The safety endpoint is adverse reactions to colchicine, adverse reactions of prednisone, or discontinued medication due to adverse reactions. In summary, the present study is to provide new evidence and strategy about anti-inflammatory therapy for recurrent In-stent restenosis after coronary intervention.
- Conditions
- In-stent Restenosis
- Being tested
- Colchicine, Prednisone, Aspirin, P2Y12 Receptor Antagonist, Lipid-lowering drug
- Keywords
- Anti-inflammatory therapy, In-stent Restenosis, Colchicine, Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Add 0.5mg QD orally and start using it within 48 hours after intervention.
PrednisoneDrug
0.5mg/kg QD orally and the dosage was reduced at a rate of 5mg/d per month until 5-10mg/d, maintained for 1 year after PCI.
AspirinDrug
Also called Acetylsalicylic Acid
Patients who have re-implanted DES should receive aspirin for at least 1 year after intervention; Patients who have underwent DEB expansion should apply aspirin for at least 3 months after intervention.
P2Y12 Receptor AntagonistDrug
Patients who have re-implanted DES should receive 1 P2Y12 receptor antagonist for at least 1 year after intervention; Patients who have underwent DEB expansion should apply the P2Y12 receptor antagonist for at least 3 months after intervention.
Lipid-lowering drugDrug
Formulate the lipid-lowering drug regimen with LDL-C<1.4mmol/L as the target on the basis of moderate intensity or above statins.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) Receives: Drug: Aspirin; Drug: P2Y12 Receptor Antagonist; Drug: Lipid-lowering drug |
| Colchicine group | Experimental | DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Colchicine (0.5mg QD, orally) Receives: Drug: Colchicine; Drug: Aspirin; Drug: P2Y12 Receptor Antagonist; Drug: Lipid-lowering drug |
| Prednisone group | Experimental | DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Prednisone (0.5mg/kg QD, orally) Receives: Drug: Prednisone; Drug: Aspirin; Drug: P2Y12 Receptor Antagonist; Drug: Lipid-lowering drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
target lesion ISR
target lesion ISR confirmed by coronary angiography for 12 months
Measured: 12 months after randomization
Secondary outcomes (3)
Major Adverse Cardiovascular Events
a composite of mortality, non-fatal myocardial infarction, non-fatal stroke and target vascular revascularization
Measured: 12 months after randomization
target lesion revascularization
incidence of revascularization due to target lesion
Measured: 12 months after randomization
other coronary artery disease revascularization
incidence of revascularization due to other coronary artery disease
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start30 Oct 2023
- Primary completion29 Oct 2026 (estimated)
- Study completion29 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for In-stent RestenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Haiyan, Fu Wai Hospital, Beijing, China
- Investigators
- Haiyan Qian, Principal investigator, Fuwai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090890
- Sponsor's protocol ID
- 2023-GSP-GG-32
- Status last verified
- Sep 2024
- First submitted
- 15 Oct 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be securely stored and will be available only upon reasonable request and with approval from the study investigators, in accordance with BMJ Open's data-sharing policy.
Publications
Yu M, Jiang Y, Song Z, Wei ZY, Tan F, Liu X, Zhang X, Zhu F, Shi Y, Huang J, Yang WX, Qian HY. Anti-inflammatory therapy for recurrent in-stent restenosis (AI-ISR): study protocol for a prospective, randomised, open-label, multicentre clinical trial. BMJ Open. 2025 Oct 27;15(10):e092235. doi: 10.1136/bmjopen-2024-092235.
PubMed 41145262
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis: a Prospective, Randomized, Open-label Trial
- ClinicalTrials.gov ID
- NCT06090890
- Acronym / sponsor ID
- 2023-GSP-GG-32
- Conditions
- In-stent Restenosis
- Keywords
- Anti-inflammatory therapy, In-stent Restenosis, Colchicine, Prednisone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Fu Wai Hospital, Beijing, ChinaUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 29 Oct 2027 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at making a comparison of the safety and efficacy of standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group) in patients with coronary heart disease who suffered from recurrent In-stent restenosis (RISR).
Detailed description
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. A total of 252 RISR patients are planned to be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group). The primary endpoint of the current study is target lesion ISR confirmed by coronary angiography for 12 months, and the secondary endpoint is Major adverse cardiovascular events (MACE: a composite of death, non-fatal myocardial infarction, non-fatal stroke, and target vascular revascularization) and each MACE component, target lesion revascularization, or other coronary artery disease revascularization for 12 months. The safety endpoint is adverse reactions to colchicine, adverse reactions of prednisone, or discontinued medication due to adverse reactions. In summary, the present study is to provide new evidence and strategy about anti-inflammatory therapy for recurrent In-stent restenosis after coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Aspirin, Drug: P2Y12 Receptor Antagonist, Drug: Lipid-lowering drugDAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) |
| Colchicine group | Experimental | Drug: Colchicine, Drug: Aspirin, Drug: P2Y12 Receptor Antagonist, Drug: Lipid-lowering drugDAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Colchicine (0.5mg QD, orally) |
| Prednisone group | Experimental | Drug: Prednisone, Drug: Aspirin, Drug: P2Y12 Receptor Antagonist, Drug: Lipid-lowering drugDAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Prednisone (0.5mg/kg QD, orally) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CAD patients over 18 years old;
- At least one coronary artery lesion meets the RISR criteria: target lesion ≥ 2 ISRs (stenosis of lumen diameter within the stent segment and within 5mm near and far of the stent ≥ 50%);
- Intended intervention treatment for RISR lesions;
- Acceptable for standard secondary prevention drug therapy for coronary heart disease, including dual antiplatelet therapy (DAPT) and statins;
- Willing to participate in the trial and complete follow-up, signing an informed consent form approved by the ethics committee
Key exclusion criteria (8 listed)
- The previous interventional treatment situation is unknown;
- The mechanism of intracavitary imaging to clarify ISR is operator-related (poor stent adhesion, incomplete dilation, and stent fracture);
- Clearly diagnose vascular inflammatory diseases or connective tissue diseases (including arteritis, Behcet's disease, systemic lupus erythematosus, etc.) involving the coronary artery;
- Immunosuppressive drugs, including glucocorticoids, have been used in the past 30 days;
- There are contraindications to the use of prednisone or colchicine, including: serious infectious diseases, including active infection, hepatitis B, hepatitis C or AIDS patients; Hematological diseases, such as thrombocytopenia, severe anemia, leukemia, etc; Uncontrolled diabetes; Severe liver and kidney function damage; Active peptic ulcer or gastrointestinal bleeding; Severe osteoporosis (with previous pathological fractures); Inflammatory bowel disease or chronic diarrhea;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineAdd 0.5mg QD orally and start using it within 48 hours after intervention. | Drug | Colchicine group |
| Prednisone0.5mg/kg QD orally and the dosage was reduced at a rate of 5mg/d per month until 5-10mg/d, maintained for 1 year after PCI. | Drug | Prednisone group |
| AspirinAlso: Acetylsalicylic AcidPatients who have re-implanted DES should receive aspirin for at least 1 year after intervention; Patients who have underwent DEB expansion should apply aspirin for at least 3 months after intervention. | Drug | Colchicine group, Prednisone group, control group |
| P2Y12 Receptor AntagonistPatients who have re-implanted DES should receive 1 P2Y12 receptor antagonist for at least 1 year after intervention; Patients who have underwent DEB expansion should apply the P2Y12 receptor antagonist for at least 3 months after intervention. | Drug | Colchicine group, Prednisone group, control group |
| Lipid-lowering drugFormulate the lipid-lowering drug regimen with LDL-C<1.4mmol/L as the target on the basis of moderate intensity or above statins. | Drug | Colchicine group, Prednisone group, control group |
Primary outcome
target lesion ISR
Time frame: 12 months after randomization
target lesion ISR confirmed by coronary angiography for 12 months
3 secondary outcomes
Major Adverse Cardiovascular Events
Time frame: 12 months after randomization
target lesion revascularization
Time frame: 12 months after randomization
other coronary artery disease revascularization
Time frame: 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 41145262Yu M, Jiang Y, Song Z, Wei ZY, Tan F, Liu X, Zhang X, Zhu F, Shi Y, Huang J, Yang WX, Qian HY. Anti-inflammatory therapy for recurrent in-stent restenosis (AI-ISR): study protocol for a prospective, randomised, open-label, multicentre clinical trial. BMJ Open. 2025 Oct 27;15(10):e092235. doi: 10.1136/bmjopen-2024-092235.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be securely stored and will be available only upon reasonable request and with approval from the study investigators, in accordance with BMJ Open's data-sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haiyan Qian principal investigator
Fuwai Hospital, Beijing, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine, Prednisone and Aspirin in people with In-stent Restenosis, run by Fu Wai Hospital, Beijing, China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Qian (+8613811386143, ahqhy712@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target lesion ISR (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.