Clinical study to evaluate the efficacy on cholesterol and blood pressure reduction and safety of Trinomia® versus usual care in patients with high cardiovascular risk without previous cardiovascular event.
- Conditions
- High cardiovascular risk without previous cardiovascular event.MedDRA version: 19.0 Level: PT Classification code 10064939 Term: Cardiovascular event prophylaxis System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-004015-13-ES
- Lead Sponsor
- Ferrer Internacional, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
Patients must meet all the following criteria:
-Men and women aged 18-75 years
-Patients (or legal representative) willing and able to sign a written informed consent form.
-Patients with high or very high cardiovascular risk without previous cardiovascular event meeting at least one of the following characteristics:
-Patients with atherosclerosis diagnosed by invasive or not invasive techniques (including coronary angiography, nuclear imaging, stress echocardiography, carotid plaque by ultrasound) and taking as aortic aneurysm, atherosclerotic plaque in carotid arteries (or IMT =1,5 mm) 12 severely calcified coronary arteries (coronary calcium> 300 U Agaston) or ABI <0.9.
-Patients diagnosed Diabetes Mellitus (I or II ) (or in treatment with oral hypoglycemic agents or insulin) with concomitant micro albumin in urine (30-300mg); protein in urine, or kidney failure. (GFR 30 y 60 ml/min using CKD-EPI method).
-Patient who (per investigator opinion) have controlled LDL-col and BP and keeping in treatment with lipid-lowering (with at least an estatine) and stable antihypertensive (at least an ACE inhibitors or ARBs) during 3 months before randomization (minimum).
-Patients who will not require a change in lipid-lowering and/or antihypertensive medication during 16 weeks after randomization.
-Women who are fertile pregnancy urine test.
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Patients meeting any of the folowing criteria will be rejected from the study.
- Patient with previous cardiovascular event clinically significant (including myocardial infarction or other form of acute coronary syndrome, angina, myocardial revascularization or other vascular territory, ischemic or hemorrhagic stroke or symptomatic DBP(class II to IV Fontaine classification).
-Contraindicated used of Trinomia®
-Patients in hemodialysis treatment or severe kidney failure (Creatinine clearance <30ml/min).
-Value of ALT/AST 3xULN or severe or active liver failure.
-Patients hypersensitivity to any pill component (atorvastatin, ramipril and aspirin), soybeans, peanuts, or ACE inhibitors or salicylates other than ASA or ramipril.
-Patients with background of asthma attacks or nasal polyps associated with asthma, or other allergic reactions due to aspirin or NSAIDs.
-Patients with recurrent active peptic ulcer, history and / or gastric or intestinal bleeding, cerebrovascular bleeding or dyspepsia common history.
-Patients with anemia or worsening hemoglobin 3 months prior to the study to suspect the presence of active bleeding and contraindicate the use of ASA.
-Patients with hemophilia or other bleeding disorders.
-Patients with myopathy, myalgia, myositis or rhabdomyolysis history of statin, or creatine kinase (CK)> 5 ULN (recommended not measure CK after hard exercise).
-Patients with a angioedema background or coughdue to ACE inhibitors.
-Patients with bilateral kidney artery stenosis or kidney artery stenosis in a single working kidney.
-Patients with suspected familial hypercholesterolemia.
-Patients with triglycerids>400mg/dl when patient is being included.
-Patients diagnosed with congestive heart failure (class III-IV NYHA).
-Patients who is not clinically correct to use Trinomia®(
(Including atorvastatin 20 or 40 mg and ramipril 2.5 to 10 mg) as a treatment of LDL cholesterol level and blood pressure.
-Patients in treatment withsome opf the following drugs: >3 antihypertensive, oral anticoagulants, and antiplatelets (except ASA), chronic treatment with NSAIDs, gemfibrozil, rifampicin, cyclosporine, aliskiren, methotrexate, telaprevir, tipranavir / ritonavir oral fusidic acid.
- Patients with life expectancy < 2 years.
-Patient pregnant, lactating or intend to become pregnant during the study and patients not taking valid contraceptive measures .
-Patients with mental disease that limits their ability to self-care.
-Patients with a medical history of drug or alcohol abuse.
-Patients who are participating in another clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method