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Study to evaluate reduced antiplatelet therapy after angiolite stent implantation in patients with coronary artery disease
EU CTIS ID: 2023-507015-35-00
What this study is testing
1. To compare the rate of target lesion failure at 12 month between Angiolite stent and Xience stent family (tested for non-inferiority) in patients treated with either the standard of care DAPT regimen or an abbreviated dual antiplatelet therapy regimen. Results related to each allocated device will be used to address the Haute Autorité de santé (HAS) requirements. 2. To compare the rate of clinically relevant bleeding events (Bleeding Academic Research Consortium 2, 3, or 5) at 12 month between an abbreviated dual antiplatelet therapy regimen and the standard-of-care dual antiplatelet therapy (tested for superiority of the experimental arm).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt
- 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
- Prior PCI (not related to the study) performed in the last 45 days
- 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
See the full eligibility 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
- Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt
- 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
- Prior PCI (not related to the study) performed in the last 45 days
- 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
- Known severe hepatic impairment Child-Pug stage C
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.