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Personalized Vs. Standard Duration of Dual Antiplatelet Therapy and New-generation Polymer-Free vs- Biodegradable-Polymer DES (PARTHENOPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135989
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
AdvicePharma Group
Information provided by (Responsible Party):
Giovanni Esposito, Federico II University

Brief Summary:

New-generation metallic drug-eluting stents represent the standard of care among patients undergoing percutaneous coronary intervention (PCI). Currently, few data are available as regards to the safety and efficacy of the Cre8 amphilimus-eluting stent (Cre8 AES, Alvimedica, Instanbul, Turkey) in comparison with the biodegradable polymer everolimus-eluting stent (Synergy EES, Boston Scientific, Marlborough, MA, USA). Results from randomized trials and meta-analyses consistently indicate that prolonged dual antiplatelet therapy (DAPT) after PCI reduces ischemic events, but invariably conveys an excess of clinically relevant bleeding, which is proportional to the duration of treatment. It has been estimated, indeed, that for every non-fatal ischemic event avoided with prolonged DAPT, two or more clinically relevant bleeding events have to be expected. Given the trade-off between benefits and risks and the lack of mortality benefit in favor of prolonged DAPT, expert consensus suggests that DAPT duration should be individualized based on ischemic versus bleeding risks. At this regard, the DAPT score has been recently proposed as standardized tool to identify patients who derive benefit or lack from a prolonged course of DAPT. However, a prospective assessment of the DAPT score is lacking and whether a personalized duration of DAPT based on the DAPT score improves the net clinical benefit remains unknown.

The objective of the study is to compared the safety and the efficacy of the Cre8 AES with the Synergy EES and a personalized DAPT duration based on the DAPT score with a standard DAPT duration among patients undergoing PCI.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Coronary Syndrome Chronic Coronary Syndrome Myocardial Infarction Device: Percutaneous coronary intervention with implantation of amphilimus-eluting stents for coronary artery disease. Device: Percutaneous coronary intervention with implantation of everolimus-eluting stents for coronary artery disease. Drug: Personalized DAPT duration Drug: Standard DAPT duration Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2106 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2-by-2 randomization
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized 2x2 Factorial Trial Comparing the Cre8 Amphilimus-sirolimus Eluting Stent vs. the Synergy Everolimus-eluting Stent and a Personalized vs. Standard Duration of Dual Antiplatelet Therapy in All-comers Patients Undergoing Percutaneous Coronary Intervention
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : October 24, 2021
Estimated Study Completion Date : October 24, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
Cre8 AES and personalized DAPT duration

Percutaneous coronary intervention with implantation of a Cre8 amphilimus- eluting stent for coronary artery disease.

Personalized duration of dual antiplatelet therapy for 3-, 6-, or 24-month after percutaneous coronary intervention based on the DAPT score.

Device: Percutaneous coronary intervention with implantation of amphilimus-eluting stents for coronary artery disease.
Implantation of polymer-free, amphilimus-eluting, drug-eluting stents
Other Name: Cre8 AES

Drug: Personalized DAPT duration
Duration of dual antiplatelet therapy according to DAPT score for 3- or 6- months in patients with low DAPT score (stable CAD or ACS, respectively) or for 24-months in patients with high DAPT score

Cre8 AES and standard DAPT duration

Percutaneous coronary intervention with implantation of a Cre8 amphilimus- eluting stent for coronary artery disease.

Standard duration of dual antiplatelet therapy for 12-month after percutaneous coronary intervention.

Device: Percutaneous coronary intervention with implantation of amphilimus-eluting stents for coronary artery disease.
Implantation of polymer-free, amphilimus-eluting, drug-eluting stents
Other Name: Cre8 AES

Drug: Standard DAPT duration
Duration of dual antiplatelet therapy for 12 months.

Synergy EES and personalized DAPT duration

Percutaneous coronary intervention with implantation of a Synergy everolimus-eluting stent for coronary artery disease.

Personalized duration of dual antiplatelet therapy for 3-, 6-, or 24-month after percutaneous coronary intervention based on the DAPT score.

Device: Percutaneous coronary intervention with implantation of everolimus-eluting stents for coronary artery disease.
Implantation of biodegradable-polymer, everolimus-eluting, drug-eluting stents
Other Name: Synergy EES

Drug: Personalized DAPT duration
Duration of dual antiplatelet therapy according to DAPT score for 3- or 6- months in patients with low DAPT score (stable CAD or ACS, respectively) or for 24-months in patients with high DAPT score

Synergy EES and standard DAPT duration

Percutaneous coronary intervention with implantation of a Synergy everolimus-eluting stent for coronary artery disease.

Standard duration of dual antiplatelet therapy for 12-month after percutaneous coronary intervention.

Device: Percutaneous coronary intervention with implantation of everolimus-eluting stents for coronary artery disease.
Implantation of biodegradable-polymer, everolimus-eluting, drug-eluting stents
Other Name: Synergy EES

Drug: Standard DAPT duration
Duration of dual antiplatelet therapy for 12 months.




Primary Outcome Measures :
  1. Number of Participants with Device-oriented composite endpoint (DOCE) for the comparison between the Cre8 AES and the Synergy EES. [ Time Frame: 12 months ]
    The composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel, or clinically-driven target-lesion revascularization.

  2. Number of Participants with Net adverse clinical endpoint (NACE) for the comparison between a personalized and standard DAPT duration. [ Time Frame: 24 months ]
    The composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or BARC type 2 to 5 bleeding at 24-month follow-up.


Secondary Outcome Measures :
  1. Number of Participants with All-cause death [ Time Frame: 12- and 24-month ]
  2. Number of Participants with Death from cardiovascular causes [ Time Frame: 12- and 24-month ]
  3. Number of Participants with Myocardial infarction [ Time Frame: 12- and 24-month ]
  4. Number of Participants with Stroke [ Time Frame: 12- and 24-month ]
  5. Number of Participants with Clinically-driven target-lesion revascularization [ Time Frame: 12- and 24-month ]
  6. Number of Participants with Definite or probable stent thrombosis [ Time Frame: 12- and 24-month ]
  7. Number of Participants with Definite stent thrombosis [ Time Frame: 12- and 24-month ]
  8. Number of Participants with Any revascularization [ Time Frame: 12- and 24-month ]
  9. Number of Participants with Clinically-driven target-vessel revascularization [ Time Frame: 12- and 24-month ]
  10. Number of Participants with Urgent target-vessel revascularization [ Time Frame: 12- and 24-month ]
  11. Number of Participants with Urgent non-target-vessel revascularization [ Time Frame: 12- and 24-month ]
  12. Number of Participants with Any target-lesion revascularization [ Time Frame: 12- and 24-month ]
  13. Number of Participants with Any target-vessel revascularization [ Time Frame: 12- and 24-month ]
  14. Number of Participants with Bleeding events [ Time Frame: 12- and 24-month ]
    Bleeding events according to the BARC, TIMI and GUSTO classification



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years;
  2. Clinical evidence of coronary artery disease requiring PCI with DES implantation;
  3. Any coronary lesion sized 2.25-4.5 mm by visual estimation.

Exclusion Criteria:

  1. Inability to provide informed consent;
  2. Active bleeding requiring medical attention (BARC ≥2);
  3. Need for chronic oral anticoagulant therapy;
  4. Planned surgery within 3 months;
  5. Known hypersensitivity or allergy to aspirin or any P2Y12 receptor inhibitor (clopidogrel, prasugrel, ticagrelor), heparin, contrast agent, or any DES-components;
  6. Previous treatment with bioresorbable vascular scaffolds;
  7. Participation in another study that has not reached the primary endpoint;
  8. A life expectancy of less than 24 months;
  9. Female of childbearing potential;
  10. Under judicial protection, tutorship or curatorship.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135989


Contacts
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Contact: Giovanni Esposito, MD, PhD +390817463075 espogiov@unina.it
Contact: Raffaele Piccolo, MD, PhD +390817464325 raffaele.piccolo@unina.it

Locations
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Italy
Casa di Cura Villa Dei Fiori Recruiting
Acerra, Naples, Italy, 80011
Contact: Ciro De Simone, MD    +390813190483    ciro.desimone@hotmail.it   
Ospedale S.Maria delle Grazie Recruiting
Pozzuoli, Naples, Italy, 80078
Contact: Marco Boccalatte    +390818552110    marco.boccalatte@aslnapoli2nord.it   
Ospedale "Maria SS. Addolorata" Recruiting
Eboli, SA, Italy, 84025
Contact: Giuseppe Bottiglieri, MD       giuseppebottiglieri3@gmail.com   
A.O.R.N. S.Giuseppe Moscati-Città Ospedaliera Not yet recruiting
Avellino, Italy, 83100
Contact: Emilio Di Lorenzo, MD    +390825203100    emiliodilorenzo4327@aosgmoscati.av.it   
Ospedale San Giuseppe Moscati Recruiting
Aversa, Italy, 81031
Contact: Gianluca Caiazzo, MD    +390815001743    gianluca.caiazzo@gmail.com   
A.O.R.N. Sant'Anna e San Sebastiano Recruiting
Caserta, Italy, 81100
Contact: Paolo Calabrò, MD, PhD    +390823232395    paolo.calabro@unicampania.it   
Ospedale San Giuliano Recruiting
Giugliano In Campania, Italy, 80014
Contact: Giovanni Napolitano, MD    +3908189553    giovanni.napolitano@aslnapoli2nord.it   
Federico II University of Naples Recruiting
Naples, Italy, 80131
Contact: Giovanni Esposito, MD PhD    0817463075 ext 0039    espogiov@unina.it   
Principal Investigator: Giovanni Esposito, MD PhD         
A.O.R.N. A. Cardarelli Recruiting
Napoli, Italy, 80131
Contact: Ciro Mauro, MD    +390817472808    ciro.mauro3@tin.it   
Ospedale San Giovanni Bosco - ASL Napoli 1 Recruiting
Napoli, Italy, 80131
Contact: Enrico Russolillo, MD    +39 3476878434    erlillo@libero.it   
Ospedale del Mare Recruiting
Napoli, Italy, 80147
Contact: Bernardino Tuccillo, MD    +3908118775265    bernardino.tuccillo@libero.it   
Ospedale Santa Maria della Pietà Recruiting
Nola, Italy, 80035
Contact: Attilio Varricchio, MD    +390818223218    attiliovarricchio13@gmail.com   
AOU San Giovanni di Dio e Ruggi d'Aragona Recruiting
Salerno, Italy, 84131
Contact: Cesare Baldi, MD    +39089673186    cesare.baldi@tiscali.it   
Sponsors and Collaborators
Federico II University
AdvicePharma Group
Publications:

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Responsible Party: Giovanni Esposito, Professor of Cardiology, Federico II University
ClinicalTrials.gov Identifier: NCT04135989    
Other Study ID Numbers: 197/19
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Acute Coronary Syndrome
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs