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New stent and shorter blood thinners could make heart treatment safer

NCT ID NCT05952206

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Oct 2023

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 95 years

Sex

Anyone

Healthy volunteers

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

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

  • Az Delta

    Roeselare, Belgium

  • Az Turnhout

    Turnhout, Belgium

  • CHC Montlégia

    Liège, Belgium

  • CHU Marie Curie

    Charleroi, Belgium

  • Chu Ambroise Pare

    Mons, Belgium

  • Chu Lille

    Lille, France

  • Chu Toulouse

    Toulouse, France

  • Complejo Hospitalario Torrecárdenas

    Almería, Spain

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, Spain

  • Hospital Clínic de Barcelona

    Barcelona, Spain

  • Hospital Clínico Universitario Virgen de La Arrixaca

    Murcia, Spain

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, Spain

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Spain

  • Hospital Germans Trias I Pujol

    Barcelona, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, Spain

  • Hospital Universitari Son Espases

    Palma de Mallorca, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Jerez de La Frontera

    Jerez de la Frontera, Spain

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain

  • Hospital Universitario Puerta de Hierro

    Madrid, Spain

  • Hospital Universitario Regional de Málaga

    Málaga, Spain

  • Hospital Universitario Vall D'Hebrón

    Barcelona, Spain

  • Hospital Universitario Virgen de La Victoria

    Málaga, Spain

  • Hospital Universitario Y Politécnico La Fe

    Valencia, Spain

  • Hospital Universitario de Bellvitge

    Barcelona, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, Spain

  • Hospital Universitario de León

    León, Spain

  • Hospital de La Citadelle

    Liège, Belgium

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, Spain

  • Hospital de Navarra

    Pamplona, Spain

  • Hospital Álvaro Cunqueiro

    Vigo, Spain

  • IMELDA

    Bonheiden, Belgium

  • Icps Massy

    Massy, France

  • Ipcs Quincy

    Quincy-sous-Sénart, France

  • ZOL GENK

    Genk, Belgium

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