Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
NCT ID: NCT05952206
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2312 participants
INTERVENTIONAL
2023-10-13
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
* Open-label for the stent type
* Open-label for the antiplatelet regimen
Study Groups
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Angiolite and abbreviated DAPT
Acute coronary syndrome patients:
* Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6 months.
* No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1M. Only the same P2Y12 inhibitor up to 12M.
Chronic coronary syndrome patients:
* Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.
* No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.
Angiolite: Sirolimus-eluting stent
The angiolite stent (iVascular, Barcelona, Spain) is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design containing a durable biostable coating composed of three layers - acrylate to ensure adhesion to the metal surface, fluoroacrylate that carries the sirolimus, and a top layer of fluoroacrylate to control drug release.
1-month DAPT
DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Then, only the same oral P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor) up to 12 months.
The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC
Xience stent family and abbreviated DAPT
Acute coronary syndrome patients:
* Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.
* No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Only the same P2Y12 inhibitor up to 12M.
Chronic coronary syndrome patients:
* Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.
* No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.
Xience: Everolimus-eluting stent
The Xience stent family (Abbott vascular, California, United States of America), characterized by an L-605 cobalt-chromium (CoCr) is a thin-strut cobalt-chromium everolimus-eluting stent with an open-cell design containing a nonerodable polymer made of PBMA, a reservoir made of a fluorinated copolymer of vinylidene fluoride and hexafluoropropylene monomers. Xience™ stent family includes XIENCE Skypoint™ and XIENCE Sierra™
1-month DAPT
DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Then, only the same oral P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor) up to 12 months.
The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC
Angiolite and standard of care DAPT
Acute coronary syndrome patients:
* Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.
* No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M.
Chronic coronary syndrome:
* Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.
* No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid.
Angiolite: Sirolimus-eluting stent
The angiolite stent (iVascular, Barcelona, Spain) is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design containing a durable biostable coating composed of three layers - acrylate to ensure adhesion to the metal surface, fluoroacrylate that carries the sirolimus, and a top layer of fluoroacrylate to control drug release.
12-month DAPT (Standard of care)
DAPT with acetylsalicylic acid and prasugrel or ticagrelor up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC
Xience stent family and standard of care DAPT
Acute coronary syndrome patients:
* Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.
* No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M.
Chronic coronary syndrome:
* Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.
* No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid.
Xience: Everolimus-eluting stent
The Xience stent family (Abbott vascular, California, United States of America), characterized by an L-605 cobalt-chromium (CoCr) is a thin-strut cobalt-chromium everolimus-eluting stent with an open-cell design containing a nonerodable polymer made of PBMA, a reservoir made of a fluorinated copolymer of vinylidene fluoride and hexafluoropropylene monomers. Xience™ stent family includes XIENCE Skypoint™ and XIENCE Sierra™
12-month DAPT (Standard of care)
DAPT with acetylsalicylic acid and prasugrel or ticagrelor up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC
Interventions
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Angiolite: Sirolimus-eluting stent
The angiolite stent (iVascular, Barcelona, Spain) is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design containing a durable biostable coating composed of three layers - acrylate to ensure adhesion to the metal surface, fluoroacrylate that carries the sirolimus, and a top layer of fluoroacrylate to control drug release.
Xience: Everolimus-eluting stent
The Xience stent family (Abbott vascular, California, United States of America), characterized by an L-605 cobalt-chromium (CoCr) is a thin-strut cobalt-chromium everolimus-eluting stent with an open-cell design containing a nonerodable polymer made of PBMA, a reservoir made of a fluorinated copolymer of vinylidene fluoride and hexafluoropropylene monomers. Xience™ stent family includes XIENCE Skypoint™ and XIENCE Sierra™
1-month DAPT
DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Then, only the same oral P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor) up to 12 months.
The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC
12-month DAPT (Standard of care)
DAPT with acetylsalicylic acid and prasugrel or ticagrelor up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length);
* Able to provide informed consent and willing to participate in the trial.
Exclusion Criteria
* Known severe hepatic impairment Child-Pug stage C;
* Prior PCI (not related to the study) performed in the last 45 days;
* Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
* Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI;
* Active major bleeding or major surgery within the last 30 days;
* Known stroke (any type) within the 30 days prior to the randomization;
* Women of childbearing potential being defined as woman from the onset of menstruation (menarche) until they become postmenopausal, unless they are permanently sterile. A postmenopausal state is clarified as having no menstrual periods for 12 consecutive months without any other medical cause. Women who have undergone permanent sterilization methods, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, can be enrolled in the study
* Currently participating in another randomized controlled trial and not yet at its primary endpoint;
* Life expectancy less than one year due to non-cardiovascular comorbidity.
18 Years
95 Years
ALL
No
Sponsors
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iVascular S.L.U.
INDUSTRY
Responsible Party
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Principal Investigators
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Manel Sabaté
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Olv Aalst
Aalst, , Belgium
IMELDA
Bonheiden, , Belgium
CHU Marie Curie
Charleroi, , Belgium
ZOL GENK
Genk, , Belgium
CHC Montlégia
Liège, , Belgium
Hospital de La Citadelle
Liège, , Belgium
Chu Ambroise Pare
Mons, , Belgium
Az Delta
Roeselare, , Belgium
Az Turnhout
Turnhout, , Belgium
Chu Lille
Lille, , France
Icps Massy
Massy, , France
Ipcs Quincy
Quincy-sous-Sénart, , France
Chu Toulouse
Toulouse, , France
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Complejo Hospitalario Torrecárdenas
Almería, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Germans Trias I Pujol
Barcelona, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital Universitario Vall D'Hebrón
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, , Spain
Hospital Universitario Jerez de La Frontera
Jerez de la Frontera, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, , Spain
Hospital Universitario de León
León, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Universitario Regional de Málaga
Málaga, , Spain
Hospital Universitario Virgen de La Victoria
Málaga, , Spain
Hospital Clínico Universitario Virgen de La Arrixaca
Murcia, , Spain
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Hospital de Navarra
Pamplona, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Y Politécnico La Fe
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Dr. Collet
Role: primary
Dr. Dewilde
Role: primary
Dr. Mohamed Ben Yedder
Role: primary
Dr. Cottens
Role: primary
Dr. Pieter-Jan Palmers
Role: primary
Dr. Saad
Role: primary
Dr. Carlier
Role: primary
Dr. Vanhaverbeke
Role: primary
Dr. Herman Van der Stighelen
Role: primary
Dr. VAN BELLE
Role: primary
Dr. Garot
Role: primary
Dr. UNTERSEEH
Role: primary
DR. LHERMUSIER
Role: primary
Ramon Calviño
Role: primary
Ricardo Fajardo
Role: primary
Salvatore Brugaleta
Role: primary
Dabit Arzamendi
Role: primary
Xavier Carrillo
Role: primary
Joan Antoni Gomez
Role: primary
Bruno García
Role: primary
Javier Fernandez Portales
Role: primary
Antonio Gómez Menchero
Role: primary
Antonio Agarrado
Role: primary
Pedro Martín
Role: primary
Armando Pérez de Prado
Role: primary
Fernando Sarnago
Role: primary
José Antonio Fernández Díaz
Role: primary
Cristóbal Urbano
Role: primary
Juan Horacio Alonso Briales
Role: primary
Eduardo Pinar
Role: primary
Vicente Peral
Role: primary
Valeriano Ruiz
Role: primary
Jose María De la Torre
Role: primary
Ramiro Trillo
Role: primary
Juan Sanchis
Role: primary
Jose Luis Díez Gil
Role: primary
Ignacio Amat
Role: primary
Andrés Iñíguez
Role: primary
Maria del Rosario Ortas
Role: primary
Other Identifiers
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ANGIODAPT-01
Identifier Type: -
Identifier Source: org_study_id
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