VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome (VERONICA)

Phase 1

Conditions: CARDIOVASCULAR DISEASES
MedDRA version: 20.0Level: PTClassification code: 10051592Term: Acute coronary syndrome Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Therapeutic area: Not possible to specify

Registration Number: CTIS2024-512436-29-00

Lead Sponsor: Fundacion Epic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 634

Inclusion Criteria

Patients with age 18 years or above; Patient is able to understand the nature of study and has provided written informed consent; Patients with Acute Coronary Syndrome and who underwent PCI during the admission with absorbable polymer stent who have been discharged on double antiplatelet therapy with Acetylsalicylic Acid and Ticagrelor or Prasugrel

Exclusion Criteria

Patients with history of intracranial bleeding; Patients with contraindication for the use of Acetylsalicylic Acid or Clopidogrel or Ticagrelor or Prasugrel; Patients with major ischemic or hemorrhagic events during the first month; Patients with Thrombocytopenia <50,000 /µL; Patients with permanent oral anticoagulation; Patient is pregnant or breast feeding;Patients with impossibility to complete 1 year of follow-up; Patient´s life-expectancy is less than 24 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To find out if the de-escalation from the more powerful antiplatelet agents prasugrel and ticagrelor to clopidogrel, guided by the VerifyNow® platelet aggregation measurement device, has a beneficial effect in the treatment of ACS.;Secondary Objective: Occurrence of events of ischemic origin: Cardiovascular death. Death from any cause. Non-fatal AMI. ACV. Definitive stent thrombosis. Need for unscheduled revascularization at one year.;Primary end point(s): Incidence of Net Adverse Cardiac Events (NACE). Net Adverse Cardiac Events, defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, Bleeding BARC type = 2. At 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Incidence of Death (Cardiovascular) at 12 months; Incidence of Death at 12 months; Incidence of Non fatal Myocardial Infarction (MI) at 12 months; Incidence of Stroke at 12 months; Incidence of Thrombosis in target lesion, at 12 months; Incidence of revascularization on target lesion at 12 months; Incidence of (BARC criteria = 2) at 12 months