Clinical trial NCT05952206: Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
Official title: Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy. A 2x2 Factorial, All-comer, Multicenter, Randomized Controlled Trial: ANGIODAPT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: angiolite
dual antiplatelet therapy
percutaneous coronary intervention
Lead sponsor: iVascular S.L.U.
Sponsor class: INDUSTRY
First posted: 2023-07-19
Enrollment: 2312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Phase III, prospective, randomized (1:1:1:1), factorial design 2x2, active control, and multicentre clinical trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
measure: 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).
timeFrame: 1 year
Secondary outcomes:
measure: 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).
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
measure: To determine the rate of Patient-Oriented Composite endpoint
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of individual components of All cause, cardiovascular, and cardiac death
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of recurrent myocardial infarction
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of target lesion revascularization
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of target vessel revascularization
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of stent thrombosis
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of clinical device success
timeFrame: Immediatly after the procedure
measure: To determine the rate of clinical procedural success
timeFrame: Immediatly after the procedure
measure: To determine the rate of bleeding events
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of net adverse clinical endpoints (NACE)
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of major adverse cardiac and cerebral events (MACCE)
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of transfusion rates
timeFrame: 1-2-3-4-5 years
measure: To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study
timeFrame: 1 year
measure: To determine the rate of adverse ischemic events at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study
timeFrame: 1 year
Locations:
city: Aalst
country: Belgium
facility: Olv Aalst
city: Bonheiden
country: Belgium
facility: IMELDA
city: Charleroi
country: Belgium
facility: CHU Marie Curie
city: Genk
country: Belgium
facility: ZOL GENK
city: Liège
country: Belgium
facility: CHC Montlégia
city: Liège
country: Belgium
facility: Hospital de La Citadelle
city: Mons
country: Belgium
facility: Chu Ambroise Pare
city: Roeselare
country: Belgium
facility: Az Delta
city: Turnhout
country: Belgium
facility: Az Turnhout
city: Lille
country: France
facility: Chu Lille
city: Massy
country: France
facility: Icps Massy
city: Quincy-sous-Sénart
country: France
facility: Ipcs Quincy
city: Toulouse
country: France
facility: Chu Toulouse
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Almería
country: Spain
facility: Complejo Hospitalario Torrecárdenas
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'Hebrón
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario Jerez de La Frontera
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: León
country: Spain
facility: Hospital Universitario de León
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de La Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Y Politécnico La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Manel Sabaté
role: PRINCIPAL_INVESTIGATOR
References: