Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy. A 2x2 Factorial, All-comer, Multicenter, Randomized Controlled Trial: ANGIODAPT
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Belgium
Olv Aalst
RECRUITING
Aalst
IMELDA
RECRUITING
Bonheiden
CHU Marie Curie
RECRUITING
Charleroi
ZOL GENK
RECRUITING
Genk
CHC Montlégia
RECRUITING
Liège
Hospital de La Citadelle
RECRUITING
Liège
Chu Ambroise Pare
RECRUITING
Mons
Az Delta
RECRUITING
Roeselare
Az Turnhout
RECRUITING
Turnhout
France
Chu Lille
RECRUITING
Lille
Icps Massy
RECRUITING
Massy
Ipcs Quincy
RECRUITING
Quincy-sous-sénart
Chu Toulouse
RECRUITING
Toulouse
Spain
Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Complejo Hospitalario Torrecárdenas
RECRUITING
Almería
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Germans Trias I Pujol
RECRUITING
Barcelona
Hospital Universitario de Bellvitge
RECRUITING
Barcelona
Hospital Universitario Vall D'Hebrón
RECRUITING
Barcelona
Hospital San Pedro de Alcantara
RECRUITING
Cáceres
Hospital Universitario Juan Ramón Jiménez
RECRUITING
Huelva
Hospital Universitario Jerez de La Frontera
RECRUITING
Jerez De La Frontera
Hospital Universitario de Gran Canaria Doctor Negrín
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario de León
RECRUITING
León
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
RECRUITING
Madrid
Hospital Universitario Regional de Málaga
RECRUITING
Málaga
Hospital Universitario Virgen de La Victoria
RECRUITING
Málaga
Hospital Clínico Universitario Virgen de La Arrixaca
RECRUITING
Murcia
Hospital Universitari Son Espases
RECRUITING
Palma De Mallorca
Hospital de Navarra
RECRUITING
Pamplona
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Clínico Universitario de Santiago
RECRUITING
Santiago De Compostela
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario Y Politécnico La Fe
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Hospital Álvaro Cunqueiro
RECRUITING
Vigo
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Sara Pich, PhD
spich@ivascular.global
+34 936 724 711
Backup
Andrea Mancera
amancera@bcccbarcelona.cat
+34645093750
Time Frame
Start Date: 2023-10-13
Estimated Completion Date: 2030-08
Participants
Target number of participants: 2312
Treatments
Experimental: 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.
Experimental: 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.
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: iVascular S.L.U.