Anti-inflammatory Therapy for Recurrent In-stent Restenosis
ConditionIn-stent Restenosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFu Wai Hospital, Beijing, China
About this 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).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Colchicine
- Prednisone
- Aspirin
- P2Y12 Receptor Antagonist
- Lipid-lowering drug
Treatment groups
252 Participants
are divided into 3 treatment groupsLocations
4Beijing Anzhen Hospital, Capital Medical University10000, BeijingBeijing Municipality, China
Beijing Friendship Hospital10000, BeijingBeijing Municipality, China
Beijing Luhe Hospital10000, BeijingBeijing Municipality, China
Fuwai Hospital BeijingBeijing Municipality, China
Sponsors and collaborators
Fu Wai Hospital, Beijing, China
Lead sponsor
Source ClinicalTrials.gov