Acute Coronary SyndromePhase 4VERONICANCT04654052
VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome
A Phase 4 study testing Clopidogrel and Previous treatment in people with Acute Coronary Syndrome and Acute Myocardial Infarction, run by Fundación EPIC at 19 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- Clopidogrel and Previous treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 637 participants
- Where
- 19 sitesSpain
- Study dates
- 2 Jul 2021to 5 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
Hospital General Universitario de Albacete
Albacete, 02006
Hospital Del Mar
Barcelona, 08003
Hospital Universitari Vall D Hebron
Barcelona, 08035
Hospital San Pedro de Alcantara
Cáceres, 10003
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario de Galdakao-Usansolo
Galdakao, 48960
Hospital Universitario de Cabueñes
Gijón, 33394
Hospital Universitario Virgen de Las Nieves
Granada, 18014
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital de León
León, 24080
Hospital Universitario Lucus Agusti
Lugo, 27003
Hospital Universitario Regional de Malaga
Málaga, 29010
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
Hospital Universitario Lozano Blesa
Zaragoza, 50009
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome (VERONICA Trial)
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).
Read the 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).
- Conditions
- Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention
- Being tested
- Clopidogrel, Previous treatment
- Keywords
- Antiplatelet therapy, Platelet Aggregation Inhibitors, Platelet Function Test, Ticagrelor, Clopidogrel, Prasugrel
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Clopidogrel during 11 months
Previous treatmentDrug
non-intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Previous treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Incidence of Death (Cardiovascular)
Death (Cardiovascular)
Measured: 12 months
Incidence of Death
Death
Measured: 12 months
Incidence of Non fatal Myocardial Infarction (MI)
Non fatal Myocardial Infarction
Measured: 12 months
Incidence of Stroke
Ischemic Stroke
Measured: 12 months
Incidence of Thrombosis in target lesion
Stent Thrombosis in target lesion
Measured: 12 months
Incidence of revascularization on target lesion
New revascularization on target lesion
Measured: 12 months
Incidence of (BARC criteria ≥ 2)
Bleeding (BARC criteria ≥ 2)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start2 Jul 2021
- Primary completion29 Jul 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654052
- Sponsor's protocol ID
- EPIC17- VERONICA
- Acronym
- VERONICA
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2020
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28855078Cuisset 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.
PubMed 28510646Deharo 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.
PubMed 29268886Lozano 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.
PubMed 29519387Kirtane 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.
PubMed 26738669Kerneis 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.
PubMed 23428007Cayla 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.
PubMed 27581531Lozano 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.
PubMed 33888241
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome (VERONICA Trial)
- ClinicalTrials.gov ID
- NCT04654052
- Acronym / sponsor ID
- VERONICA / EPIC17- VERONICA
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VerifyNow® PRUTest ≤30 (De-escalated Prasugrel Ticagrelor ) | Other | Drug: ClopidogrelPatients 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. |
| VerifyNow® PRUTest ≤30 (Prasugrel or Ticagrelor ) | Other | Drug: Previous treatmentActive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelClopidogrel during 11 months | Drug | VerifyNow® PRUTest ≤30 (De-escalated Prasugrel Ticagrelor ) |
| Previous treatmentnon-intervention | Drug | VerifyNow® PRUTest ≤30 (Prasugrel or Ticagrelor ) |
Primary outcome
Incidence of Net Adverse Cardiac Events (NACE)
Time frame: 12 months
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.
7 secondary outcomes
Incidence of Death (Cardiovascular)
Time frame: 12 months
Incidence of Death
Time frame: 12 months
Incidence of Non fatal Myocardial Infarction (MI)
Time frame: 12 months
Incidence of Stroke
Time frame: 12 months
Incidence of Thrombosis in target lesion
Time frame: 12 months
Incidence of revascularization on target lesion
Time frame: 12 months
Incidence of (BARC criteria ≥ 2)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 28855078Sibbing 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.
- Background: PubMed 28510646Cuisset 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.
- Background: PubMed 29268886Deharo 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.
- Background: PubMed 29519387Lozano 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.
- Background: PubMed 26738669Kirtane 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.
- Background: PubMed 23428007Kerneis 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.
- Background: PubMed 27581531Cayla 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.
- Derived from this study: PubMed 33888241Lozano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel and Previous treatment in people with Acute Coronary Syndrome and Acute Myocardial Infarction, run by Fundación EPIC at 19 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Net Adverse Cardiac Events (NACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04654052, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.