Coronary Artery Disease Clinical Trial
— PARTHENOPEOfficial 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
Verified date | February 2024 |
Source | Federico II University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 2106 |
Est. completion date | October 24, 2024 |
Est. primary completion date | October 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Casa di Cura Villa Dei Fiori | Acerra | Naples |
Italy | A.O.R.N. S.Giuseppe Moscati-Città Ospedaliera | Avellino | |
Italy | Ospedale San Giuseppe Moscati | Aversa | |
Italy | A.O.R.N. Sant'Anna e San Sebastiano | Caserta | |
Italy | Ospedale "Maria SS. Addolorata" | Eboli | SA |
Italy | Ospedale San Giuliano | Giugliano In Campania | |
Italy | Federico II University of Naples | Naples | |
Italy | A.O.R.N. A. Cardarelli | Napoli | |
Italy | Ospedale del Mare | Napoli | |
Italy | Ospedale San Giovanni Bosco - ASL Napoli 1 | Napoli | |
Italy | Ospedale Santa Maria della Pietà | Nola | |
Italy | Ospedale S.Maria delle Grazie | Pozzuoli | Naples |
Italy | AOU San Giovanni di Dio e Ruggi d'Aragona | Salerno |
Lead Sponsor | Collaborator |
---|---|
Federico II University | AdvicePharma Group |
Italy,
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Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289. — View Citation
Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2016 Sep 6;68(10):1082-115. doi: 10.1016/j.jacc.2016.03.513. Epub 2016 Mar 29. No abstract available. — View Citation
Navarese EP, Andreotti F, Schulze V, Kolodziejczak M, Buffon A, Brouwer M, Costa F, Kowalewski M, Parati G, Lip GY, Kelm M, Valgimigli M. Optimal duration of dual antiplatelet therapy after percutaneous coronary intervention with drug eluting stents: meta-analysis of randomised controlled trials. BMJ. 2015 Apr 16;350:h1618. doi: 10.1136/bmj.h1618. Erratum In: BMJ. 2016 Oct 17;355:i5600. — View Citation
Piccolo R, Gargiulo G, Franzone A, Santucci A, Ariotti S, Baldo A, Tumscitz C, Moschovitis A, Windecker S, Valgimigli M. Use of the Dual-Antiplatelet Therapy Score to Guide Treatment Duration After Percutaneous Coronary Intervention. Ann Intern Med. 2017 Jul 4;167(1):17-25. doi: 10.7326/M16-2389. Epub 2017 Jun 13. — View Citation
Piccolo R, Windecker S. Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: A Tale of 2 Decades With New Perspectives in the Era of New-Generation Drug-Eluting Stents. Circ Cardiovasc Interv. 2016 Feb;9(2):e003587. doi: 10.1161/CIRCINTERVENTIONS.116.003587. No abstract available. — View Citation
Raber L, Piccolo R. CardioPulse: Different bleeding scores and which one should we use? Eur Heart J. 2016 Jan 21;37(4):327-31. No abstract available. — View Citation
Rozemeijer R, Stein M, Voskuil M, van den Bor R, Frambach P, Pereira B, Koudstaal S, Leenders GE, Timmers L, Rittersma SZ, Kraaijeveld AO, Agostoni P, Roes KC, Doevendans PA, Stella PR; ReCre8 Study Investigators. Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent. Circulation. 2019 Jan 2;139(1):67-77. doi: 10.1161/CIRCULATIONAHA.118.037707. — View Citation
Spencer FA, Prasad M, Vandvik PO, Chetan D, Zhou Q, Guyatt G. Longer- Versus Shorter-Duration Dual-Antiplatelet Therapy After Drug-Eluting Stent Placement: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Jul 21;163(2):118-26. doi: 10.7326/M15-0083. — View Citation
Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Device-oriented composite endpoint (DOCE) for the comparison between the Cre8 AES and the Synergy EES. | The composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel, or clinically-driven target-lesion revascularization. | 12 months | |
Primary | Number of Participants with Net adverse clinical endpoint (NACE) for the comparison between a personalized and standard DAPT duration. | 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. | 24 months | |
Secondary | Number of Participants with All-cause death | 12- and 24-month | ||
Secondary | Number of Participants with Death from cardiovascular causes | 12- and 24-month | ||
Secondary | Number of Participants with Myocardial infarction | 12- and 24-month | ||
Secondary | Number of Participants with Stroke | 12- and 24-month | ||
Secondary | Number of Participants with Clinically-driven target-lesion revascularization | 12- and 24-month | ||
Secondary | Number of Participants with Definite or probable stent thrombosis | 12- and 24-month | ||
Secondary | Number of Participants with Definite stent thrombosis | 12- and 24-month | ||
Secondary | Number of Participants with Any revascularization | 12- and 24-month | ||
Secondary | Number of Participants with Clinically-driven target-vessel revascularization | 12- and 24-month | ||
Secondary | Number of Participants with Urgent target-vessel revascularization | 12- and 24-month | ||
Secondary | Number of Participants with Urgent non-target-vessel revascularization | 12- and 24-month | ||
Secondary | Number of Participants with Any target-lesion revascularization | 12- and 24-month | ||
Secondary | Number of Participants with Any target-vessel revascularization | 12- and 24-month | ||
Secondary | Number of Participants with Bleeding events | Bleeding events according to the BARC, TIMI and GUSTO classification | 12- and 24-month |
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