2024-514610-13-00招募中3 期
ARGO Colchicine versus Placebo in Acute Myocarditis Patients to Reduce Late Gadolinium Enhancement Mass on Cardiac Magnetic Resonance and the risk of Clinical Outcomes: The ARGO trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 24
- 主要终点
- - Extent of late gadolinium enhancement (% of left ventricle mass) evaluated on CMR at 6 months. OR - Composite clinical outcome at 6 months, defined as the occurrence of heart Failure or acute myocarditis recurrence; or a clinically relevant chest pain (defined as leading to an unplanned/urgent consultation or hospitalization or requiring an additional treatment); or a sustained ventricular arrhythmia; left ventricular assistance; or heart transplantation; or cardiovascular death during the s
研究概览
简要总结
The main objective of this study will be to assess the efficacy of colchicine versus placebo on a co-primary endpoint including inflammatory myocardial damage on CMR or composite clinical outcomes at 6 months.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years and < 65 years old,
- •Written informed consent of the patient obtained.
- •Symptom onset ≤ 21 days,
- •Chest pain and/or heart failure symptoms and/or palpitations
- •Troponins > 99 percentile of reference value,
- •Myocarditis diagnostic confirmed by CMR according to the Lake Louise criteria (2009 or later),
- •No evidence for ischemic heart disease as assessed by coronary angiography or coronary computed tomography angiography for patients with age > 40-year-old with one or more cardiovascular risk factor (hypertension, smoking, hypercholesterolemia, diabetes, personal or family history of coronary artery disease)
- •Woman of child-bearing age with an effective contraception method according to the investigator for the duration of treatment and 1 month after
- •Man accepting effective contraception for the duration of treatment and 1 month after
- •Patients with affiliation to the French Health Care System “sécurité sociale”
排除标准
- •Cardiogenic shock requiring inotropes or vasopressors (patients with inotropes or vasopressors discontinued for >24h can be enrolled)
- •Sarcoidosis
- •Severe liver (Child Pugh C) or known renal dysfunction (known GFR < 30 ml/min according Cockroft),
- •Cytopenia: hemoglobin less than 100 grams/L, white blood cell count less than 3.0 G/L, platelet count less than 100 G/L
- •Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive tract as uncontrolled ulcerative colitis or active Crohn disease)
- •Immunosuppression, spinal cord aplasia
- •Hemopathy
- •Hypereosinophilia > 0.5 G/L
- •Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive local laboratory test
- •Administration of any investigational drug or participation in another interventional trial, within 30 days before randomization.
- •Patient under treatment having an interaction with colchicine [macrolides (telithromycin, azithromycin, clarithromycin, dirithromycin, erythromycin, josamycin, midecamycin, roxithromycin), pristinamycin, cyclosporine, verapamil, all protease inhibitors, telaprevir, CYP3A4 powerful inhibitors, azole antifungals, vitamin K antagonists],
- •Giant cell myocarditis or eosinophilic myocarditis
- •Patients under legal protection: under guardianship (trusteeship or curatorship),
- •Acute coronary syndrome or known coronary stenosis > 50%
- •Toxic cardiomyopathy
- •Active chronic inflammatory disease, chronic active infection, evolving cancer
- •A recent severe sepsis (7 days)
- •Hypersensitivity to IMP’s active substances (colchicine) or to any of the excipients (including lactose, sucrose, microcrystalline cellulose, colloidal silica, magnesium stearate colorants: E127, Dual Red 40)
- •Any known contra-indication to CMR or associated contract products (claustrophobia, intra-ocular metal foreign bodies, clips such as cerebral, carotid, or aortic aneurysm, cochlear implants, any implant held in by magnet, non-MR compatible cardiac devices (pace maker or defibrillator), history of hypersensitivity to gadoteric acid or to gadolinium contrast agents or to meglumine),
- •Chronic treatment with corticosteroids or NSAIDs or immunosuppressant.
结局指标
主要结局
- Extent of late gadolinium enhancement (% of left ventricle mass) evaluated on CMR at 6 months. OR - Composite clinical outcome at 6 months, defined as the occurrence of heart Failure or acute myocarditis recurrence; or a clinically relevant chest pain (defined as leading to an unplanned/urgent consultation or hospitalization or requiring an additional treatment); or a sustained ventricular arrhythmia; left ventricular assistance; or heart transplantation; or cardiovascular death during the s
- Extent of late gadolinium enhancement (% of left ventricle mass) evaluated on CMR at 6 months. OR - Composite clinical outcome at 6 months, defined as the occurrence of heart Failure or acute myocarditis recurrence; or a clinically relevant chest pain (defined as leading to an unplanned/urgent consultation or hospitalization or requiring an additional treatment); or a sustained ventricular arrhythmia; left ventricular assistance; or heart transplantation; or cardiovascular death during the s
次要结局
- Rate of Serious Adverse Events related to colchicine at 6 months, rate of permanent discontinuation on 6 months, rate of diarrhea, rate of nausea and/or vomiting and rate of myelotoxicity on 6 months, renal function during hospitalization and at 6 months.
- Efficacy of colchicine between the two groups : a- Composite clinical outcome at 1 year b- Each component of the composite clinical endpoint at 6 months and 1 year
- Rate of heart failure or recurrence of acute myocarditis
- Rates of clinically relevant chest pain (defined as requiring unscheduled/urgent consultation or hospitalisation or additional treatment)
- Rate of sustained ventricular arrhythmias
- Rate of left ventricular assistance
- Rate of heart transplantation
- Cardiovascular mortality rate
- LVEF (Left Ventricular Ejection Fraction), GEDV (TeleDiastolic Volume) and TSV (TeleSystolic Volume) volumes determined on a 6-month cardiac MRI using Corelab centralised reading.
- Relative change in LVEF, LVOT and STV volumes, determined by follow-up transthoracic echocardiography at 6 months,
- The relative change in late gadolinium enhancement and oedema determined on a 6-month follow-up cardiac MRI scan using Corelab centralised reading.
- Cardiac magnetic resonance criteria at 6 months: value of native T1 and T2 mapping (ms), percentage of extracellular volume.
- Serum biomarkers at admission, 24H and 48H (after admission) and at 6 months: Troponin (I or T depending on investigator site), NT-pro BNP, CRP and CK
- For centres participating in the bio-collection: specific inflammatory markers IL-6, ST2 and IL-1β at inclusion; 24 and 48 hours after inclusion if possible; and at 6 months (after randomisation
- Burden of VSE (Ventricular ExtraSystoles) measured at 3 months on Holter ECG
研究者
Ivestigatror
Scientific
Assistance Publique Hopitaux De Paris
研究点 (24)
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