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 groupsSponsors and collaborators
Source ClinicalTrials.gov