New stent and shorter blood thinners could make heart treatment safer
NCT ID NCT05952206
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests two things at once in 2312 people with coronary artery disease: a new drug-coated stent (Angiolite) versus a standard stent, and a shorter course of blood thinners versus the usual longer course. The goal is to see if the new stent works as well and if shorter blood thinners cause less bleeding without increasing heart attacks or strokes. Participants are randomly assigned to one of four groups and followed for 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sirolimus-eluting stent (Angiolite) and abbreviated dual antiplatelet therapy (shorter course of blood thinners)
- What this could lead to
- If successful, this could show that a newer stent works just as well as current ones, and that a shorter course of blood thinners can lower bleeding risk without raising heart attack or stroke risk.
- What could go wrong
- This is a phase 3 trial, but results may not apply to all patients. The shorter blood thinner course might increase the risk of stent clotting or heart attacks in some people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
2,312 people
The number who actually took part.
- Started
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Oct 2023
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 95 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Az Delta
Roeselare, Belgium
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Az Turnhout
Turnhout, Belgium
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CHC Montlégia
Liège, Belgium
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CHU Marie Curie
Charleroi, Belgium
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Chu Ambroise Pare
Mons, Belgium
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Chu Lille
Lille, France
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Chu Toulouse
Toulouse, France
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Complejo Hospitalario Torrecárdenas
Almería, Spain
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Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
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Hospital Clínic de Barcelona
Barcelona, Spain
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Hospital Clínico Universitario Virgen de La Arrixaca
Murcia, Spain
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Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain
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Hospital Clínico Universitario de Valencia
Valencia, Spain
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Hospital Clínico Universitario de Valladolid
Valladolid, Spain
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Hospital Germans Trias I Pujol
Barcelona, Spain
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Hospital San Pedro de Alcantara
Cáceres, Spain
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Hospital Universitari Son Espases
Palma de Mallorca, Spain
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Hospital Universitario 12 de Octubre
Madrid, Spain
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Hospital Universitario Jerez de La Frontera
Jerez de la Frontera, Spain
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Hospital Universitario Juan Ramón Jiménez
Huelva, Spain
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Hospital Universitario Marqués de Valdecilla
Santander, Spain
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Hospital Universitario Miguel Servet
Zaragoza, Spain
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Hospital Universitario Puerta de Hierro
Madrid, Spain
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Hospital Universitario Regional de Málaga
Málaga, Spain
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Hospital Universitario Vall D'Hebrón
Barcelona, Spain
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Hospital Universitario Virgen de La Victoria
Málaga, Spain
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Hospital Universitario Y Politécnico La Fe
Valencia, Spain
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Hospital Universitario de Bellvitge
Barcelona, Spain
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Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Spain
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Hospital Universitario de León
León, Spain
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Hospital de La Citadelle
Liège, Belgium
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Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
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Hospital de Navarra
Pamplona, Spain
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Hospital Álvaro Cunqueiro
Vigo, Spain
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IMELDA
Bonheiden, Belgium
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Icps Massy
Massy, France
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Ipcs Quincy
Quincy-sous-Sénart, France
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ZOL GENK
Genk, Belgium
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