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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Colchicine

    Drug

    Add 0.5mg QD orally and start using it within 48 hours after intervention.

  • Prednisone

    Drug

    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

    Drug

    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

    Drug

    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

    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.

Treatment groups

252 Participants
are divided into 3 treatment groups
Group A: control groupActive comparator 3 interventions
Group B: Colchicine groupExperimental treatment 4 interventions
Group C: Prednisone groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

target lesion ISR

target lesion ISR confirmed by coronary angiography for 12 months

Time frame
12 months after randomization

Secondary outcomes

1

Major Adverse Cardiovascular Events

a composite of mortality, non-fatal myocardial infarction, non-fatal stroke and target vascular revascularization

Time frame
12 months after randomization
2

target lesion revascularization

incidence of revascularization due to target lesion

Time frame
12 months after randomization
3

other coronary artery disease revascularization

incidence of revascularization due to other coronary artery disease

Time frame
12 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fu Wai Hospital, Beijing, China

Lead sponsor

Source ClinicalTrials.gov
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