Coronary Artery Disease
Conditions
Keywords
angiolite, dual antiplatelet therapy, percutaneous coronary intervention
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.
Interventions
DEVICEAngiolite: 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.
DEVICEXience: 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™
DRUG1-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
DRUG12-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
Sponsors
iVascular S.L.U.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking: * Open-label for the stent type * Open-label for the antiplatelet regimen
Intervention model description
Phase III, prospective, randomized (1:1:1:1), factorial design 2x2, active control, and multicentre clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To determine the rate of target vessel revascularization | 1-2-3-4-5 years |
| To determine the rate of stent thrombosis | 1-2-3-4-5 years |
| To determine the rate of clinical device success | Immediatly after the procedure |
| To determine the rate of clinical procedural success | Immediatly after the procedure |
| To determine the rate of bleeding events | 1-2-3-4-5 years |
| To determine the rate of Patient-Oriented Composite endpoint | 1-2-3-4-5 years |
| To determine the rate of major adverse cardiac and cerebral events (MACCE) | 1-2-3-4-5 years |
| To determine the rate of transfusion rates | 1-2-3-4-5 years |
| 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 | 1 year |
| 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 | 1 year |
| To determine the rate of net adverse clinical endpoints (NACE) | 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 |
| To determine the rate of target lesion revascularization | 1-2-3-4-5 years |
Countries
Belgium, France, Spain
Contacts
Primary ContactSara Pich, PhD
Backup ContactAndrea Mancera
Outcome results
None listed