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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Epic

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Not possible to specify

Trial duration

27 Mar 2026 → ongoing

Decision date (initial)

2024-04-03

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

FUNDACION EPIC

External identifiers

EU CT number

2024-512436-29-00

EudraCT number

2020-005645-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

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 objectives 1

1. 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.

Conditions and MedDRA coding

CARDIOVASCULAR DISEASES

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Epic

Sponsor organisation

Fundacion Epic

Address

Avenida Condesa Sagasta 10 1c

City

Leon

Postcode

24001

Country

Spain

Scientific contact point

Organisation

Fundacion Epic

Contact name

ARMANDO PEREZ DE PRADO

Public contact point

Organisation

Fundacion Epic

Contact name

ARMANDO PEREZ DE PRADO

Locations

1 EU/EEA country · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications