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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiolite and abbreviated DAPT | Experimental | Acute coronary syndrome patients:
Chronic coronary syndrome patients:
|
|
| Xience stent family and abbreviated DAPT | Experimental | Acute coronary syndrome patients:
Chronic coronary syndrome patients:
|
|
| Angiolite and standard of care DAPT | Active Comparator | Acute coronary syndrome patients:
Chronic coronary syndrome:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiolite: Sirolimus-eluting stent | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manel Sabaté | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMELDA | Bonheiden | Belgium | ||||
| CHU Marie Curie |
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Phase III, prospective, randomized (1:1:1:1), factorial design 2x2, active control, and multicentre clinical trial.
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Masking:
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|
| Xience stent family and standard of care DAPT | Active Comparator | Acute coronary syndrome patients:
Chronic coronary syndrome:
|
|
|
|
| Xience: Everolimus-eluting stent | Device | 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 | Drug | 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) | Drug | 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 |
|
| 1 year |
| 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 |
| 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 net adverse clinical endpoints (NACE) | 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 |
| 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 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C028145 | 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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