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 procedures
Conditions
Interventions
Trade Name: Trinomia 100 mg/20 mg/10 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: RAMIPRIL
CAS Number: 87333-19-5
Other de
Sponsors
Ferrer Internacional, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determinate in patients with high cardiovascular risk without previous cardiovascular accident, during 16 weeks treatment if Trinomia® is similar to monocomponents given at the same time (equivalent therapeutical doses), in terms of Blood pressure and c-LDL levels.; Secondary Objective: Percentage of patients with controlled BP and c-LDL after 16 weeks as per ESC. -Percentage of change in in BP and , c-LDL levels, total chol, c-HDL; c-no-HDL and triglicerids between baseline and week 16 values in both treatment group. -Risk evolution using SCORE and PCE calculator (as per ACC/AHA 2013 guidelines), in both treatment groups after 16 treatment weeks. -Safety of Trinomia® treatment and usual treatment, as per notified AA (including withdrow due to AA and SAEs, also death), and lab test reports with some laboratory abnormality. ;Primary end point(s): Primary end point is SBP evaluation and percentage of LDL-c levels changed between randomization and week 16.; Timepoint(s) of evaluation of this end point: SBP evaluation: In Screening(V1); Baseline(V2); Week 8 (V3); and Week 16 (EoT). LDL-c level (percentage of changing) In screening visit (V1) and week 16 (EoT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Total cholesterol, HDL-c; no HDL c and triglicerids between baseline and week 16.In screening and EoT. -SCORE scale and PCE calculator (baseline-W16) -Safety of Trinomia treatment is defined by notified SAEs, withdrawals due to AEs or SAEs (including death) during the study, and lab reports with abnormal values. (baseline and EoT) SBP evaluation: In Screening(V1); Baseline(V2); Week 8 (V3); and Week 16 (EoT). LDL-c level (percentage of changing) In screening visit (V1) and week 16 (EoT) ; Timepoint(s) of evaluation of this end point: -Value of SBP/DBP and LDL-c levels between baseline and week 16 of treatment. -Total cholesterol, HDL-c; no HDL c and triglicerids between baseline and week 16. -SCORE scale and PCE calculator (baseline-W16). -Safety of Trinomia treatment is defined by notified SAEs, withdrawals due to AEs or SAEs (including death), and lab reports with abnormal values. | — |
Countries
Mexico, Portugal, Spain
Contacts
Public ContactDepartamento de Ensayos Clínicos
Dynamic Science S.L.
Outcome results
None listed