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临床试验/EUCTR2017-002343-14-IE
EUCTR2017-002343-14-IE进行中（未招募）1 期

A multicentre, randomised, open-label, parallel-group trial to study the safety and efficacyof a new therapeutic strategy (Trinomia®*) versus usual care on LDLc and blood pressurelevels in patients with atherothrombotic cardiovascular disease: The APOLO trial. - APOLO

Ferrer Internacional, S.A.0 个研究点目标入组 700 人开始时间: 2017年10月2日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
700
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1) Age =18; both genders.
  • •2) Subjects with atherothrombotic cardiovascular disease, with at least one of the following
  • •clinical events, the last one having occurred within the required time frame
  • •2.a) Previous acute myocardial infarction (>6 months after the event).
  • •2.b) Cardiac revascularization with coronary stent (>6 months after the
  • •surgery) or coronary artery bypass grafting (3 months after the surgery).
  • •2.c) Diagnosis of stable angina (patients to be submitted to a coronary
  • •interventional procedure or functional (ischemic test) and/or anatomic (coronary
  • •stenosis assessed by coronary angiography or computed tomography).
  • •2.d) Previous ischemic stroke with atherothrombotic background, including
  • •lacunar infarction (>6 months after the event).
  • •2.e) Peripheral artery disease, including patients with stable claudication (>6
  • •months) or operated patients (revascularization or amputation) (2 weeks after the
  • •3) Subjects treated with an ACE inhibitor or ARB, statin and acetylsalicylic acid for
  • •secondary cardiovascular prevention.
  • •4) Subjects who are clinically stable, with no changes in medication for LDLc and blood
  • •pressure control within the last 3 months, and in whom it is not planned to change their
  • •medication for LDLc and blood pressure in the following 6 months after randomisation.
  • •5) Written informed consent form.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 700
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 190

排除标准

  • •1) Any contraindication to the polypill, such as:
  • •1.a) Patients on haemodialysis or with severe renal impairment (defined by
  • •glomerular filtration rate (calculated by CKD-EPI formula) <30 ml/min).
  • •1.b) Patients with moderate hepatic impairment defined as alanine aminotransferase
  • •(ALT) or aspartate aminotransferase (AST) elevation >3 times the upper limit of
  • •normal (ULN) or severe hepatic impairment (defined by the Child-Pugh criteria for
  • •patients with ALT/AST >5 times the ULN).
  • •1.c) Patients with hypersensitivity to any of the components of the polypill
  • •(atorvastatin, ramipril or acetylsalicylic acid), soy, peanuts, or to any ACE inhibitors
  • •or salicylates other than acetylsalicylic acid or ramipril.
  • •1.d) Patients with a history of asthma episodes or nasal polyps associated with
  • •asthma, or other allergic reactions due to acetylsalicylic acid or other nonsteroidal
  • •anti-inflammatory drugs.
  • •1.e) Patients with active recurrent peptic ulcer, history and/or active gastric or
  • •intestinal bleeding, cerebrovascular haemorrhage, or regular history of
  • •1.f) Patients with anaemia (haemoglobin <10 g/dl) or worsening of
  • •haemoglobin, suggesting the presence of active bleeding, according to
  • •investigator’s criteria, which may contraindicate the use of acetylsalicylic
  • •1.g) Patients with haemophilia or other disorders of coagulation.
  • •1.h) Patients with myopathy, myalgia, myositis or a history of rhabdomyolysis,
  • •or those that have creatine kinase (CK) tested and whose result is > 5 LSN
  • •(it is recommended not to measure CK after intense exercise).
  • •1.i) Patients with a history of angioedema or cough due to ACE inhibitors.
  • •1.j) Patients with bilateral renal artery stenosis or renal artery stenosis with a
  • •single functioning kidney.
  • •2) Patients in whom, at the discretion of the investigator, it is not clinically
  • •appropriate to use the polypill (including atorvastatin 20 or 40 mg and ramipril
  • •2.5 to 10 mg) as treatment for the control of LDLc cholesterol and blood
  • •3) Subjects with suspected familiar hypercholesterolemia or triglycerides >400
  • •4) Patients with hypotensive or haemodynamically unstable states.
  • •5) Subjects with diagnosed of congestive heart failure (New York Heart
  • •Association [NYHA] class III-IV).
  • •6) Patients diagnosed with atrial fibrillation.
  • •7) Patients with haemorrhagic stroke, cardioembolic stroke or stroke of
  • •undetermined aetiology.
  • •8) Patients taking any of the following medication:
  • •- Treatment with a fixed dose combination of 3 antihypertensives.
  • •- Chronic treatment with non-steroidal anti-inflammatory drugs; its occasional use is
  • •allowed. It will be considered occasional use when ibuprofen (maximal dose 1200
  • •mg/day), or other non-steroidal anti-inflammatory drugs at equivalent dose, is used
  • •for a maximum of 3 days in a period of one month.
  • •- Potent inhibitor of CYP3A4 or transport proteins (e.g. ciclosporin, rifampicin,
  • •telitromicin, claritromicin, delavirdin, estiripentol, ketoconazol, voriconazol,
  • •itraconazol, posaconazol and HIV protease inhibitors such as ritonavir, lopinavir,
  • •atazanavir, indinavir, darunavir, telaprevir, etc).
  • •- Other medications as: Gemfibrozil, Aliskiren, Methotrexate, Fusidic acid (oral) or
  • •Sacubitril /Valsartan
  • •9) Women who are pregnant, breastfeeding or planning to become pregnant during
  • •the study, as well as fertile women who do not take adequate contraceptive
  • •measures such as: combined (oestrogen and progestogen containing) hormonal
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