Patients with atherothrombotic cardiovascular disease MedDRA version: 20.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849
Conditions
Sponsors
Ferrer Internacional, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: § Age =18 and 12 months after the event). ? Cardiac revascularization with coronary stent (>12 months after the surgery) or coronary artery bypass grafting (3 months after the surgery). ? 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). ? Previous ischemic stroke with atherothrombotic background, including lacunar infarction (>12 months after the event). ? Peripheral artery disease, including patients with stable claudication (>6 months) or operated patients (revascularization or amputation) (2 weeks after the surgery). § Subjects treated with an ACE inhibitor or ARB, statin and acetylsalicylic acid for secondary cardiovascular prevention. § 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. § 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 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: § Any contraindication to the polypill, such as: ? Patients on haemodialysis or with severe renal impairment (defined by creatinine clearance 3 times the upper limit of normal (ULN) or with severe or active hepatic impairment. ? 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. ? Patients with a history of asthma episodes or nasal polyps associated with asthma, or other allergic reactions due to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. ? Patients with active recurrent peptic ulcer, history and/or active gastric or intestinal bleeding, cerebrovascular haemorrhage, or regular history of dyspepsia. ? Patients with anaemia (haemoglobin 5 ULN (it is recommended not to measure the creatine kinase level after intense exercise). ? Patients with a history of angioedema or cough due to ACE inhibitors. ? Patients with bilateral renal artery stenosis or renal artery stenosis with a single functioning kidney. § 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 pressure. § Subjects with suspected familiar hypercholesterolemia or triglycerides >400 mg/dl. § Subjects with diagnosed of congestive heart failure (New York Heart Association [NYHA] class III-IV). § Patients diagnosed with atrial fibrillation. § Patients with haemorrhagic stroke, cardioembolic stroke or stroke of undetermined aetiology. § 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 contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence). In fertile women, additional pregnancy tests should be performed at monthly intervals. § Presence of major systemic illnesses that in the investigator’s opinion may interfere with the study procedures and/or assessments. § Patients with a mental illness (such as dementia) or living in a nursing home or committed to an institution by an order issued by the judicial or the administrative authorities that may limit their capacity of self-care. § Medical history of drug/alcohol abuse. § Participants in another clinical trial. § Patients treated with the polypill prior to randomisation. § Patients with active cancer or with chemotherapy treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the treatment with a new therapeutic strategy (the Fuster-CNIC-Ferrer cardiovascular polypill) is non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDLc) and blood pressure reductions in subjects with atherothrombotic cardiovascular disease after 6 months of follow-up;Secondary Objective: § To assess whether the treatment with the cardiovascular polypill is non-inferior to usual care in terms of LDLc and blood pressure reductions according to coronary artery disease, stroke and peripheral artery disease of patients. § To evaluate the percentage of patients with LDLc and blood pressure under control according to 2016 European Guidelines on cardiovascular disease prevention. § To determine changes in total cholesterol, LDLc, high-density lipoprotein cholesterol (HDLc), non-HDLc, triglycerides and blood pressure after 6 months of follow-up. § To evaluate satisfaction with medication and patients' preferences in preventive treatment of secondary cardiovascular events with a cardiovascular polypill. § To evaluate the safety of the cardiovascular polypill.;Primary end point(s): Systolic blood pressure and LDLc;Timepoint(s) of evaluation of this end point: At the end of the study treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): § Systolic blood pressure and LDLc levels in subgroups of patients with atherothrombotic cardiovascular disease with coronary artery disease, stroke and/or peripheral artery disease. § The percentage of patients with LDLc and blood pressure under control as per the 2016 European Guidelines on Cardiovascular Disease Prevention § Changes in systolic/diastolic blood pressure and total cholesterol, LDLc, HDLc, non-HDLc and triglyceride levels § The change in patients’ satisfaction with medication according to the abbreviated Treatment Satisfaction Questionnaire for Medication19 § The safety of the polypill;Timepoint(s) of evaluation of this end point: At month 6 and throughout the study. | — |
Countries
Ireland, Italy, Mexico, Portugal, Spain
Contacts
Public ContactDepartamento de Ensayos Clínicos
Dynamic Science S.L.
Outcome results
None listed