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

Primary Purpose

Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Clopidogrel
Previous treatment
Sponsored by
Fundación EPIC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Antiplatelet therapy, Platelet Aggregation Inhibitors, Platelet Function Test, Ticagrelor, Clopidogrel, Prasugrel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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.

Sites / Locations

  • Hospital Universitario Virgen de La ArrixacaRecruiting
  • Hospital General Universitario de AlbaceteRecruiting
  • Hospital Del MarRecruiting
  • Hospital Universitari Vall D HebronRecruiting
  • Hospital General Universitario de Ciudad RealRecruiting
  • Hospital San Pedro de AlcantaraRecruiting
  • Hospital Universitario de Galdakao-UsansoloRecruiting
  • Hospital Universitario de CabueñesRecruiting
  • Hospital Universitario Virgen de Las NievesRecruiting
  • Hospital Universitari de BellvitgeRecruiting
  • Hospital Universitario Juan Ramon JimenezRecruiting
  • Hospital de LeónRecruiting
  • Hospital Universitario Lucus AgustiRecruiting
  • Hospital Universitario Regional de MalagaRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Universitario Marques de ValdecillaRecruiting
  • Hospital Clinico Universitario de ValladolidRecruiting
  • Hospital Universitario Lozano BlesaRecruiting
  • Hospital Universitario Miguel ServetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

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

VerifyNow® PRUTest ≤30 (Prasugrel or Ticagrelor )

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of Death (Cardiovascular)
Death (Cardiovascular)
Incidence of Death
Death
Incidence of Non fatal Myocardial Infarction (MI)
Non fatal Myocardial Infarction
Incidence of Stroke
Ischemic Stroke
Incidence of Thrombosis in target lesion
Stent Thrombosis in target lesion
Incidence of revascularization on target lesion
New revascularization on target lesion
Incidence of (BARC criteria ≥ 2)
Bleeding (BARC criteria ≥ 2)

Full Information

First Posted
September 20, 2020
Last Updated
December 14, 2022
Sponsor
Fundación EPIC
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1. Study Identification

Unique Protocol Identification Number
NCT04654052
Brief Title
VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome
Acronym
VERONICA
Official Title
VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome (VERONICA Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación EPIC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Clinical practice guidelines recommend the use of double anti-aggregation with acetylsalicylic acid and a P2Y12 receptor inhibitor (P2Y12 i) in acute coronary syndrome (ACS) and in the choice of the latter it is very important to consider two opposing risks, Ischemia and hemorrhage. In the era of clopidogrel, platelet function tests (PFT) attempted to determine which patients were at risk of thrombotic events, but after the publication of 3 randomized studies, the absence of benefit from the use of PFT was proven except in very selected cases. The TOPIC trial opened the door to the descaling strategy of P2Y12 i with a decrease in hemorrhagic events without increasing ischemic complications. In that study, where the randomization was not based on PFT, it was demonstrated that there is a subgroup of patients who with prasugrel and ticagrelor pose an excessive level of antiaggregation and carry a high rate of complications, as high as 33 % in the net clinical end-point of ischemia and bleeding BARC ≥ 2 at 1 year. Based on that data, the recently published guidelines of the non-ST acute coronary syndrome of the European Society of Cardiology recommend with class IIB that de-escalation of P2Y12 i maybe considered an alternative strategy, especially in ACS patients deemed unsuitable for potent platelet inhibition. De-escalation may be done based on clinical judgment, or guided by platelet function testing, or CYP2C19 genotyping depending on the patient's risk profile and availability of respective assays. In VERONICA, The researchers try to demonstrate with the current study the usefulness of PFT to diagnose patients with excessive level of antiaggregation and to see if in them a descaling strategy similar to that of TOPIC could be associated with a decrease in the combined ischemia and hemorrhage events. We propose a prospective, randomized and multicentre trial in patients with ACS who have been treated with acetylsalicylic acid (AAS) + ticagrelor or prasugrel. After 1 month of discharge, antiaggregation measurement will be carried out with the VerifyNow® device (Werfen, Spain) and those with PRU ≤30 will be randomized 1:1 to continue with ticagrelor or prasugrel(control branch) vs. de-escalation to clopidogrel (intervention branch) for the remaining 11 months. The primary end-point will be the rate of the combined net clinical benefit consisting of cardiovascular death, nonfatal acute myocardial infarction (AMI), nonfatal stroke and bleeding BARC ≥2 at 12 months. The total number of randomized patients will be 634 and there will be subgroup analysis of the primary end-point by diabetes, type of acute coronary syndrome or type of drug (ticagrelor or prasugrel).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention
Keywords
Antiplatelet therapy, Platelet Aggregation Inhibitors, Platelet Function Test, Ticagrelor, Clopidogrel, Prasugrel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
634 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VerifyNow® PRUTest ≤30 (De-escalated Prasugrel Ticagrelor )
Arm Type
Other
Arm Description
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.
Arm Title
VerifyNow® PRUTest ≤30 (Prasugrel or Ticagrelor )
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel during 11 months
Intervention Type
Drug
Intervention Name(s)
Previous treatment
Intervention Description
non-intervention
Primary Outcome Measure Information:
Title
Incidence of Net Adverse Cardiac Events (NACE)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of Death (Cardiovascular)
Description
Death (Cardiovascular)
Time Frame
12 months
Title
Incidence of Death
Description
Death
Time Frame
12 months
Title
Incidence of Non fatal Myocardial Infarction (MI)
Description
Non fatal Myocardial Infarction
Time Frame
12 months
Title
Incidence of Stroke
Description
Ischemic Stroke
Time Frame
12 months
Title
Incidence of Thrombosis in target lesion
Description
Stent Thrombosis in target lesion
Time Frame
12 months
Title
Incidence of revascularization on target lesion
Description
New revascularization on target lesion
Time Frame
12 months
Title
Incidence of (BARC criteria ≥ 2)
Description
Bleeding (BARC criteria ≥ 2)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Íñigo Lozano, MD, PhD
Phone
+34630901145
Email
inigo.lozano@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fundación EPIC
Phone
+34987876135
Email
iepic@fundacionepic.org
Facility Information:
Facility Name
Hospital Universitario Virgen de La Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Albacete
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Ciudad Real
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital San Pedro de Alcantara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Galdakao-Usansolo
City
Galdakao
ZIP/Postal Code
48960
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Cabueñes
City
Gijón
ZIP/Postal Code
33394
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Juan Ramon Jimenez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de León
City
León
ZIP/Postal Code
24080
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Lucus Agusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Regional de Malaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
28855078
Citation
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Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
29268886
Citation
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.
Results Reference
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PubMed Identifier
29519387
Citation
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.
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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.
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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.
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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.
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Results Reference
derived

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VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome

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