VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome

NCT04654052 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: EPIC17- VERONICA
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 19

Brief Summary

The objective of the study is to establish a de-scaling strategy of P2Y12 inhibitors (P2Y12 i) with a decrease in hemorrhagic events without increasing ischemic complications based on a Platelet Function Test (PFT).

Conditions

Acute Coronary Syndrome; Acute Myocardial Infarction; Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

Antiplatelet therapy; Platelet Aggregation Inhibitors; Platelet Function Test; Ticagrelor; Clopidogrel; Prasugrel

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (7)

• Incidence of Death (Cardiovascular)

  12 months

• Incidence of Death

  12 months

• Incidence of Non fatal Myocardial Infarction (MI)

  12 months

• Incidence of Stroke

  12 months

• Incidence of Thrombosis in target lesion

  12 months

Study Arms (2)

VerifyNow® PRUTest ≤30 (De-escalated Prasugrel Ticagrelor )

OTHER

Patients with ACS on Prasugrel or Ticagrelor and PRU ≤ 30 at the end of the first month will be de-escalated to Clopidogrel 75 mg q.d during 11 months.

Drug: Clopidogrel

VerifyNow® PRUTest ≤30 (Prasugrel or Ticagrelor )

OTHER

Active comparator: Patients with ACS on Prasugrel or Ticagrelor and PRU ≤ 30 at the end of the first month will continue with these previous treatment during 11 months.

Drug: Previous treatment

Interventions

Clopidogrel DRUG

Clopidogrel during 11 months

VerifyNow® PRUTest ≤30 (De-escalated Prasugrel Ticagrelor )

Previous treatment DRUG

non-intervention

VerifyNow® PRUTest ≤30 (Prasugrel or Ticagrelor )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, who have been discharged on double. antiplatelet therapy with Acetylsalicylic Acid and Ticagrelor or Prasugrel.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (19)

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital General Universitario de Albacete

Albacete, 02006, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10003, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario de Galdakao-Usansolo

Galdakao, 48960, Spain

Location

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

Location

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital de León

León, 24080, Spain

Location

Hospital Universitario Lucus Agusti

Lugo, 27003, Spain

Location

Hospital Universitario Regional de Malaga

Málaga, 29010, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (8)

• Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Holdt L, Felix SB, Parma R, Klopotowski M, Schwinger RHG, Rieber J, Huber K, Neumann FJ, Koltowski L, Mehilli J, Huczek Z, Massberg S; TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet. 2017 Oct 14;390(10104):1747-1757. doi: 10.1016/S0140-6736(17)32155-4. Epub 2017 Aug 28.

  PMID: 28855078 BACKGROUND

• Cuisset T, Deharo P, Quilici J, Johnson TW, Deffarges S, Bassez C, Bonnet G, Fourcade L, Mouret JP, Lambert M, Verdier V, Morange PE, Alessi MC, Bonnet JL. Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study. Eur Heart J. 2017 Nov 1;38(41):3070-3078. doi: 10.1093/eurheartj/ehx175.

  PMID: 28510646 BACKGROUND

• Deharo P, Quilici J, Camoin-Jau L, Johnson TW, Bassez C, Bonnet G, Fernandez M, Ibrahim M, Suchon P, Verdier V, Fourcade L, Morange PE, Bonnet JL, Alessi MC, Cuisset T. Benefit of Switching Dual Antiplatelet Therapy After Acute Coronary Syndrome According to On-Treatment Platelet Reactivity: The TOPIC-VASP Pre-Specified Analysis of the TOPIC Randomized Study. JACC Cardiovasc Interv. 2017 Dec 26;10(24):2560-2570. doi: 10.1016/j.jcin.2017.08.044.

  PMID: 29268886 BACKGROUND

• Lozano I, Robles V, Vegas JM, Rondan J. De-Escalation of the P2Y12 Inhibitor After Acute Coronary Syndromes According to On-Treatment Platelet Reactivity: A Promising Step of Enormous Magnitude That Should Be Explored. JACC Cardiovasc Interv. 2018 Mar 12;11(5):507-508. doi: 10.1016/j.jcin.2018.01.246. No abstract available.

  PMID: 29519387 BACKGROUND

• Kirtane AJ, Parikh PB, Stuckey TD, Xu K, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Mazzaferri EL Jr, Parvataneni R, Maehara A, Genereux P, Mehran R, Stone GW. Is There an Ideal Level of Platelet P2Y12-Receptor Inhibition in Patients Undergoing Percutaneous Coronary Intervention?: "Window" Analysis From the ADAPT-DES Study (Assessment of Dual AntiPlatelet Therapy With Drug-Eluting Stents). JACC Cardiovasc Interv. 2015 Dec 28;8(15):1978-1987. doi: 10.1016/j.jcin.2015.08.032.

  PMID: 26738669 BACKGROUND

• Kerneis M, Silvain J, Abtan J, Cayla G, O'Connor SA, Barthelemy O, Vignalou JB, Beygui F, Brugier D, Martin R, Collet JP, Montalescot G. Switching acute coronary syndrome patients from prasugrel to clopidogrel. JACC Cardiovasc Interv. 2013 Feb;6(2):158-65. doi: 10.1016/j.jcin.2012.09.012.

  PMID: 23428007 BACKGROUND

• Cayla G, Cuisset T, Silvain J, Leclercq F, Manzo-Silberman S, Saint-Etienne C, Delarche N, Bellemain-Appaix A, Range G, El Mahmoud R, Carrie D, Belle L, Souteyrand G, Aubry P, Sabouret P, du Fretay XH, Beygui F, Bonnet JL, Lattuca B, Pouillot C, Varenne O, Boueri Z, Van Belle E, Henry P, Motreff P, Elhadad S, Salem JE, Abtan J, Rousseau H, Collet JP, Vicaut E, Montalescot G; ANTARCTIC investigators. Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome (ANTARCTIC): an open-label, blinded-endpoint, randomised controlled superiority trial. Lancet. 2016 Oct 22;388(10055):2015-2022. doi: 10.1016/S0140-6736(16)31323-X. Epub 2016 Aug 28.

  PMID: 27581531 BACKGROUND

• Lozano I, Rumoroso JR, Perez de Prado A, Moreno R, Hernandez F. Antiplatelet Therapy After Stenting at the Crossroads: Easiest or Personalized Therapy? JACC Cardiovasc Interv. 2021 Apr 26;14(8):929-930. doi: 10.1016/j.jcin.2021.03.019. No abstract available.

  PMID: 33888241 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: December 4, 2020
• Study Start: July 2, 2021
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

ES (19)