Clinical Trials – CRM (Cardio-Renal-Metabolic)

CRM Cardio-Renal-Metabolism

We want to test the hypothesis that treatment with 300 milligrams (mg) of inclisiran sodium administered subcutaneously (sc) on day 1, day 90 and, thereafter, every 6 months in patients at high cardiovascular (CV) risk without previous disease Major atherosclerotic cardiovascular disease (ACE) will significantly reduce the risk of major adverse cardiovascular events.

INCLUSION CRITERIA:

Participants of both sexes ≥40 and <80 years old.

At high risk of suffering a first MACE:

  1.  Signs of atherosclerotic coronary artery disease on CT or invasive coronary angiogram defined as ≥20% and <50% stenosis in the left main artery or ≥20% and <70% stenosis in any major pericardial artery.
  2. coronary artery calcium (CAC) score obtained by CT ≥ 100 Agaston units.
  3. High risk of ACE at 10 years ≥ 20%.
  4. Intermediate risk of ACE 10 between 7.5% and 20% with at least 2 factors that increase the risk.
  • If you are receiving prior lipid-lowering treatment, you must take it for at least a month and continue with it during the study.
  • LDL ≥ 70mg/dl and <190mg/dl

EXCLUSION CRITERIA:

History of major ACE event defined as any of the following:

  1. Acute coronary syndrome (ACS) in the 12 months before randomization,
  2. Previous myocardial infarction at any time before randomization, or
  3. Previous ischemic stroke
  4. Peripheral arterial disease (PAD)
  • Having undergone revascularization caused by ischemia in a coronary arterial bed or
  • Absence of coronary atherosclerosis on CT angiography or invasive coronary angiography during the 2 years before randomization.
  • Coronary artery calcium (CAC) score of 0 obtained within 2 years prior to randomization.
  • Active liver disease or liver dysfunction.
  • Previous, current, or planned treatment with a monoclonal antibody (MA) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab or alirocumab).
  • Pregnant or lactating women

The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of MACE in participants with established ASCVD and LDL-C ≥1.8 mmol/L. (70 mg/dL)

INCLUSION CRITERIA:

• Male or female ≥ 40 years of age

• Fasting LDL-C ≥ 1,8 mmol/L (70 mg/dL) at screening visit

• At the screening visit, participants must be stable (≥4 weeks) and on a well-tolerated lipid-lowering regimen (including, for example, with or without Ezetimibe) which must include high-intensity statin therapy with atorvastatin ≥ 40 mg QD or rosuvastatin ≥20 mg.

• Established CV disease, defined as any of the following:

  • Previous myocardial infarction
  • Previous ischemic stroke
  • Symptomatic peripheral arterial disease (PAD).

EXCLUSION CRITERIA:

•NYHA class III or IV

• Previous exposure to inclisiran or any other non-targeted PCSK9 mAb therapy, within 2 years prior to the first study visit.

• Pregnant or lactating women (infants)

• Women of childbearing potential, unless using contraception during study treatment dosing.

Multinational registry of patients in secondary cardiovascular prevention. Prospective non-interventional study of cardiovascular prevention.

It aims to determine whether the 2021 ESC Guidelines or applicable national CV disease guidelines are followed in daily practice regarding the co-prescription of antiplatelet agents, RAAS antagonists and statins in patients on secondary CV prevention after one year of follow-up from the first post-discharge visit (reference date).

Inclusion criteria

1. Patients over 18 years of age and under 80 years of age.

2. Being discharged after being hospitalized for a CV event.

3. Signing of the trial-specific informed consent.

Exclusion Criteria

1. Patients with mental disabilities, with drug abuse, in hospices or other facts that make the patient's participation in the study difficult.

2. Pregnant women.

He dedicated himself to the adaptation of therapeutic strategies used in patients with stable atherosclerotic disease and the use of recommended treatments according to clinical guidelines.

Studied the impact of the implementation of the Spanish Consensus on LDL cholesterol control rates among patients admitted for Acute Coronary Syndrome (ACS).