Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy

Phase 3

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Drug: 12-month DAPT (Standard of care); Drug: 1-month DAPT

• Registration Number: NCT05952206
• Lead Sponsor: iVascular S.L.U.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-19
• Study Start: 2023-10-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-08
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2312

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Angiolite and standard of care DAPT	12-month DAPT (Standard of care)	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.
Xience stent family and standard of care DAPT	12-month DAPT (Standard of care)	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.
Angiolite and abbreviated DAPT	1-month 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.
Xience stent family and abbreviated DAPT	1-month 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.
Angiolite and abbreviated DAPT	1-month 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.
Xience stent family and abbreviated DAPT	1-month 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.
Angiolite and standard of care DAPT	12-month DAPT (Standard of care)	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.
Xience stent family and standard of care DAPT	12-month DAPT (Standard of care)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (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 Clínico Universitario Virgen de La Arrixaca; 🇪🇸 Murcia, Spain

Hospital Universitario Regional de Málaga; 🇪🇸 Málaga, Spain

Hospital Universitario Virgen de La Victoria; 🇪🇸 Málaga, 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