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Anti-inflammatory Therapy for Recurrent In-stent Restenosis
Sponsor: Fu Wai Hospital, Beijing, China
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 recurrent In-stent restenosis (RISR).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
252
Start Date
2023-10-30
Completion Date
2027-10-29
Last Updated
2025-08-08
Healthy Volunteers
No
Conditions
Interventions
Colchicine
Add 0.5mg QD orally and start using it within 48 hours after intervention.
Prednisone
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.
Aspirin
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 Antagonist
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 drug
Formulate the lipid-lowering drug regimen with LDL-C\<1.4mmol/L as the target on the basis of moderate intensity or above statins.
Locations (4)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Luhe Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital
Beijing, Beijing Municipality, China