Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
ANGIODAPT
1 other identifier
interventional
2,312
3 countries
39
Brief Summary
Factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Immediately after the first randomization, the study compares (second randomization) the superiority in bleeding Bleeding Academic Research Consortium (BARC) 2, 3, or 5 of abbreviated DAPT versus standard of care. Both primary endpoints will be evaluated at 12 months of follow-up. The study will be open-label for the stent type and the antiplatelet regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Oct 2023
Longer than P75 for phase_3 coronary-artery-disease
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
October 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
May 16, 2025
May 1, 2025
2.8 years
May 24, 2023
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To determine the rate of target lesion failure between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group.
1 year
To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) between an abbreviated DAPT regimen and the standard of care DAPT (tested for superiority of the experimental arm).
1 year
Secondary Outcomes (2)
To determine the rate of adverse ischemic events between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy (tested for non-inferiority).
1 year
Rate of target lesion failure between angiolite stent and Xience stent family (Skypoint or Sierra) (tested for non-inferiority) in the standard of care subgroup.
1 year
Other Outcomes (14)
To determine the rate of Patient-Oriented Composite endpoint
1-2-3-4-5 years
To determine the rate of individual components of All cause, cardiovascular, and cardiac death
1-2-3-4-5 years
To determine the rate of recurrent myocardial infarction
1-2-3-4-5 years
- +11 more other outcomes
Study Arms (4)
Angiolite and abbreviated DAPT
EXPERIMENTALAcute 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.
Xience stent family and abbreviated DAPT
EXPERIMENTALAcute 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.
Angiolite and standard of care DAPT
ACTIVE COMPARATORAcute 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 stent family and standard of care DAPT
ACTIVE COMPARATORAcute 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.
Interventions
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.
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™
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
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
Eligibility Criteria
You may qualify if:
- Age \>18 - \< 95 years;
- 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.
You may not qualify if:
- Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iVascular S.L.U.lead
Study Sites (39)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manel Sabaté
Hospital Clinic of Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Masking: * Open-label for the stent type * Open-label for the antiplatelet regimen
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2023
First Posted
July 19, 2023
Study Start
October 13, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2030
Last Updated
May 16, 2025
Record last verified: 2025-05