- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00638794
Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents (ADAPT-DES)
22. ledna 2013 aktualizováno: Cardiovascular Research Foundation, New York
Prospective, multicenter, registry of at least 11,000 (and up to 15,000) consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
To determine:
- the frequency, timing and correlates (clinical and angiographic) of drug-eluting stent (DES) thrombosis in a patient population with few clinical and angiographic exclusion criteria,
- the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis in separate phases stratified by whether the patient is taking dual (aspirin plus clopidogrel) or single (aspirin alone) antiplatelet therapy, and
- combining the findings from the above 2 objectives, to identify a cohort representing a significant proportion of all patients at increased risk to have early and/or late DES stent thrombosis.
Typ studie
Pozorovací
Zápis (Aktuální)
8575
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55407
- Minneapolis Heart Institute
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New York
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New York, New York, Spojené státy, 10027
- Columbia University Medical Center & New York Presbyterian
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28202
- Carolinas Medical Center
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Greensboro, North Carolina, Spojené státy, 27401
- LeBauer Cardiovascular Research
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Pinehurst, North Carolina, Spojené státy, 28374
- FirstHealth Moore Regional Hospital
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Ohio
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Columbus, Ohio, Spojené státy, 43210
- Ohio State University Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Spojené státy, 18105
- Lehigh Valley Hospital and Health Network
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Tennessee
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Kingsport, Tennessee, Spojené státy, 37660
- Wellmont Holston Valley Medical Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
Patient undergoing PCI in whom at least one DES is implanted and in whom PCI of all treated lesions is successful (diameter stenosis <30% with TIMI 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intraprocedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery).
Popis
Inclusion Criteria:
- Patients undergoing PCI in whom at least one DES is implanted and in whom PCI of all treated lesions is successful (diameter stenosis <30% with TIMI 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intra-procedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery). One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting as long as at least one DES is implanted. However, the procedure must be successful and uncomplicated (as defined above) for all lesions (DES + BMS + non-stent).
- Aspirin use: Adequate aspirin loading given prior to PCI: at least 300 mg non enteric coated oral aspirin at least 1 hour prior to the procedure or 324 mg chewed or 250 mg IV aspirin at least 30 minutes prior to the procedure.
- Patient has Hematocrit between 30 and 52% and Platelet Count greater than 100,000/µl.
- For US sites: Only FDA-approved DES stents may be used in this study. For OUS sites: Only DES stents that are CE marked for approval may be used in this study.
- PCI performed with unfractionated or low molecular weight heparin, or bivalirudin as the procedural antithrombin.
- Patient or guardian able to provide informed written consent.
Exclusion Criteria:
Patients in whom blood for Accumetrics VerifyNow platelet function testing cannot be drawn after the minimum clopidogrel loading duration and Glycoprotein (GP) IIb/IIIa inhibitor washout duration as follows:
- Clopidogrel loading: Clopidogrel loading pre PCI is recommended, but post PCI clopidogrel loading is acceptable per standard of care. In all patients (whether or not clopidogrel is initiated pre or post PCI), prior to blood drawing for VerifyNow platelet function testing, a 600 mg loading dose must have been given at least 6 hours prior, or a 300 mg loading dose must have been given at least 12 hours prior, or the patient must have been maintained on at least 75 mg of clopidogrel daily for at least 5 days.
- GP IIb/IIIa inhibitor washout: Eptifibatide or tirofiban must have been discontinued for at least 24 hours prior to VerifyNow platelet function testing. Abciximab must have been discontinued for at 10 days prior to VerifyNow platelet function testing.
- Inability of the VerifyNow system to measure either Aspirin, P2Y12 or IIb/IIIa platelet responsiveness.
- Severe allergy to stainless steel, contrast dye, all anti-thrombin agents (unfractionated and low molecular weight heparin and bivalirudin), aspirin or clopidogrel that cannot be adequately pre-medicated.
- Concurrent enrollment in another trial that involves an investigational stent, antithrombotic or antiplatelet agent. Patient in other investigational trials that have not reached their primary endpoint may be enrolled in ADAPT-DES as long as the other trials do not involve an investigational stent, antithrombotic or antiplatelet agent and inclusion of such patient will have no effect on the endpoint of either study.
- Patients in whom bypass graft surgery is planned within 2 years.
- Patients with stent thrombosis before the performance of pre-discharge VerifyNow platelet function testing.
- Patients unwilling or unable to complete clinical follow-up for the duration of the study.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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Surgical
Patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.
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Observational
Consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications
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PCI using any FDA approved drug-eluting stent; Taxus Express2 - Paclitaxel-Eluting Coronary Stent System Cypher Sirolimus-eluting coronary stent Endeavor ABT-578 Eluting Coronary Stent System Xience V Everolimus Eluting Coronary Stent System
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only.
Časové okno: 30 days, 1 year, 2 year
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30 days, 1 year, 2 year
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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ARC definite, probable, possible or any stent thrombosis, utilizing primary only and then primary + secondary thromboses; death, MI, recurrent ischemia necessitating repeat target lesion and target vessel intervention and MACE.
Časové okno: 1 day, 30 days, 1 year, 2 year
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1 day, 30 days, 1 year, 2 year
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Gregg W. Stone, MD, CardioVascular Research Foundation
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Redfors B, Kirtane AJ, Liu M, Musikantow DR, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Ben-Yehuda O, Mehran R, Stone GW. Dual Antiplatelet Therapy Discontinuation, Platelet Reactivity, and Adverse Outcomes After Successful Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2022 Apr 25;15(8):797-806. doi: 10.1016/j.jcin.2022.01.300. Erratum In: JACC Cardiovasc Interv. 2022 Oct 10;15(19):2001.
- Gupta R, Kirtane AJ, Liu Y, Crowley A, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Mehran R, Ben-Yehuda O, Stone GW. Impact of Smoking on Platelet Reactivity and Clinical Outcomes After Percutaneous Coronary Intervention: Findings From the ADAPT-DES Study. Circ Cardiovasc Interv. 2019 Nov;12(11):e007982. doi: 10.1161/CIRCINTERVENTIONS.119.007982. Epub 2019 Nov 1.
- Maehara A, Mintz GS, Witzenbichler B, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri EL Jr, McAndrew T, Genereux P, Mehran R, Kirtane AJ, Stone GW. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents. Circ Cardiovasc Interv. 2018 Nov;11(11):e006243. doi: 10.1161/CIRCINTERVENTIONS.117.006243.
- Giustino G, Redfors B, Kirtane AJ, Mehran R, Dangas GD, Witzenbichler B, Neumann FJ, Weisz G, Genereux P, Maehara A, McAndrew T, Farhan S, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Brodie BR, Stuckey TD, Gurbel P, Ben-Yehuda O, Stone GW. Platelet Reactivity and Risk of Ischemic Stroke After Coronary Drug-Eluting Stent Implantation: From the ADAPT-DES Study. JACC Cardiovasc Interv. 2018 Jul 9;11(13):1277-1286. doi: 10.1016/j.jcin.2018.01.263. Epub 2018 Jun 13.
- Redfors B, Genereux P, Witzenbichler B, Kirtane AJ, McAndrew T, Weisz G, Stuckey TD, Henry TD, Maehara A, Mehran R, Stone GW. Bleeding Severity After Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Mar;11(3):e005542. doi: 10.1161/CIRCINTERVENTIONS.117.005542.
- Redfors B, Genereux P, Witzenbichler B, McAndrew T, Diamond J, Huang X, Maehara A, Weisz G, Mehran R, Kirtane AJ, Stone GW. Percutaneous Coronary Intervention of Saphenous Vein Graft. Circ Cardiovasc Interv. 2017 May;10(5):e004953. doi: 10.1161/CIRCINTERVENTIONS.117.004953.
- Gupta R, Kirtane AJ, Ozan MO, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Mehran R, Ben-Yehuda O, Stone GW. Platelet Reactivity and Clinical Outcomes After Coronary Artery Implantation of Drug-Eluting Stents in Subjects With Peripheral Arterial Disease: Analysis From the ADAPT-DES Study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents). Circ Cardiovasc Interv. 2017 Mar;10(3):e004904. doi: 10.1161/CIRCINTERVENTIONS.116.004904.
- Yu J, Mehran R, Baber U, Ooi SY, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Brodie BR, Stuckey TD, Maehara A, Xu K, Ben-Yehuda O, Kirtane AJ, Stone GW. Sex Differences in the Clinical Impact of High Platelet Reactivity After Percutaneous Coronary Intervention With Drug-Eluting Stents: Results From the ADAPT-DES Study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents). Circ Cardiovasc Interv. 2017 Feb;10(2):e003577. doi: 10.1161/CIRCINTERVENTIONS.116.003577.
- Wang B, Mintz GS, Witzenbichler B, Souza CF, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Matsumura M, Yamamoto MH, Parvataneni R, Kirtane AJ, Stone GW, Maehara A. Predictors and Long-Term Clinical Impact of Acute Stent Malapposition: An Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) Intravascular Ultrasound Substudy. J Am Heart Assoc. 2016 Dec 22;5(12):e004438. doi: 10.1161/JAHA.116.004438.
- Kobayashi N, Mintz GS, Witzenbichler B, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Parvataneni R, Kirtane AJ, Stone GW, Maehara A. Prevalence, Features, and Prognostic Importance of Edge Dissection After Drug-Eluting Stent Implantation: An ADAPT-DES Intravascular Ultrasound Substudy. Circ Cardiovasc Interv. 2016 Jul;9(7):e003553. doi: 10.1161/CIRCINTERVENTIONS.115.003553.
- Yun KH, Mintz GS, Witzenbichler B, Inaba S, Shimizu T, Metzger DC, Rinaldi MJ, Mazzaferri EL Jr, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Kirtane AJ, Stone GW, Maehara A. Relationship Between Platelet Reactivity and Culprit Lesion Morphology: An Assessment From the ADAPT-DES Intravascular Ultrasound Substudy. JACC Cardiovasc Imaging. 2016 Jul;9(7):849-854. doi: 10.1016/j.jcmg.2015.08.019. Epub 2016 Feb 17.
- 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.
- Dohi T, Maehara A, Witzenbichler B, Rinaldi MJ, Mazzaferri EL Jr, Duffy PL, Weisz G, Neumann FJ, Henry TD, Cox DA, Stuckey TD, Brodie BR, Litherland C, Brener SJ, Kirtane AJ, Mintz GS, Stone GW. Etiology, Frequency, and Clinical Outcomes of Myocardial Infarction After Successful Drug-Eluting Stent Implantation: Two-Year Follow-Up From the ADAPT-DES Study. Circ Cardiovasc Interv. 2015 Dec;8(12):e002447. doi: 10.1161/CIRCINTERVENTIONS.114.002447.
- Brodie BR, Garg A, Stuckey TD, Kirtane AJ, Witzenbichler B, Maehara A, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Mehran R, Parvataneni R, Stone GW. Fixed and Modifiable Correlates of Drug-Eluting Stent Thrombosis From a Large All-Comers Registry: Insights From ADAPT-DES. Circ Cardiovasc Interv. 2015 Oct;8(10):e002568. doi: 10.1161/CIRCINTERVENTIONS.114.002568.
- Genereux P, Giustino G, Witzenbichler B, Weisz G, Stuckey TD, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri E, Yadav M, Francese DP, Palmerini T, Kirtane AJ, Litherland C, Mehran R, Stone GW. Incidence, Predictors, and Impact of Post-Discharge Bleeding After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2015 Sep 1;66(9):1036-45. doi: 10.1016/j.jacc.2015.06.1323.
- Petersen JE, Bouwens EA, Tamayo I, Turner L, Wang CW, Stins M, Theander TG, Hermida J, Mosnier LO, Lavstsen T. Protein C system defects inflicted by the malaria parasite protein PfEMP1 can be overcome by a soluble EPCR variant. Thromb Haemost. 2015 Nov;114(5):1038-48. doi: 10.1160/TH15-01-0018. Epub 2015 Jul 9.
- Baber U, Mehran R, Kirtane AJ, Gurbel PA, Christodoulidis G, Maehara A, Witzenbichler B, Weisz G, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Xu K, Parise H, Brodie BR, Stuckey TD, Stone GW. Prevalence and impact of high platelet reactivity in chronic kidney disease: results from the Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents registry. Circ Cardiovasc Interv. 2015 Jun;8(6):e001683. doi: 10.1161/CIRCINTERVENTIONS.115.001683.
- Kang SJ, Mintz GS, Witzenbichler B, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Shimizu T, Xu K, Kirtane AJ, Stone GW, Maehara A. Effect of obesity on coronary atherosclerosis and outcomes of percutaneous coronary intervention: grayscale and virtual histology intravascular ultrasound substudy of assessment of dual antiplatelet therapy with drug-eluting stents. Circ Cardiovasc Interv. 2014 Dec 31;8(1):e001392. doi: 10.1161/CIRCINTERVENTIONS.114.001392. Print 2015 Jan.
- Witzenbichler B, Maehara A, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri EL Jr, Xu K, Parise H, Mehran R, Mintz GS, Stone GW. Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study. Circulation. 2014 Jan 28;129(4):463-70. doi: 10.1161/CIRCULATIONAHA.113.003942. Epub 2013 Nov 26.
- Stone GW, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri E, Gurbel PA, Xu K, Parise H, Kirtane AJ, Brodie BR, Mehran R, Stuckey TD; ADAPT-DES Investigators. Platelet reactivity and clinical outcomes after coronary artery implantation of drug-eluting stents (ADAPT-DES): a prospective multicentre registry study. Lancet. 2013 Aug 17;382(9892):614-23. doi: 10.1016/S0140-6736(13)61170-8. Epub 2013 Jul 26. Erratum In: Lancet. 2014 Mar 29;383(9923):1128.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2008
Primární dokončení (Aktuální)
1. prosince 2011
Dokončení studie (Aktuální)
1. ledna 2013
Termíny zápisu do studia
První předloženo
28. února 2008
První předloženo, které splnilo kritéria kontroly kvality
18. března 2008
První zveřejněno (Odhad)
19. března 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
23. ledna 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. ledna 2013
Naposledy ověřeno
1. srpna 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ADAPT-DES
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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