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

Coronary Artery Disease Clinical Trial

— ANGIODAPT  

Official title:

Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy. A 2x2 Factorial, All-comer, Multicenter, Randomized Controlled Trial: ANGIODAPT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05952206
• Other study ID #: ANGIODAPT-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2023
• Est. completion date: July 2029

Study information

• Verified date: July 2023
• Source: iVascular S.L.U.
• Contact: Sara Pich, PhD
• Phone: +34 936 724 711
• Email: spich[@]ivascular.global
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Factorial 2x2, all-comer, multicentre, single-blinded, 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 patient-observer blinded (participant and investigator doing follow-ups) for the stent type and open-label for the antiplatelet regimen.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2312
• Est. completion date: July 2029
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• All-comers patients;

• 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;

• 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;

• Known pregnancy at time of randomization;

• Female who is breastfeeding at time of randomization;

• Women of childbearing potential. Defined: a woman is considered potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Angiolite: Sirolimus-eluting stent
The angiolite stent (iVascular, Barcelona, Spain) is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design containing a durable biostable coating composed of three layers - acrylate to ensure adhesion to the metal surface, fluoroacrylate that carries the sirolimus, and a top layer of fluoroacrylate to control drug release.
• Xience: Sirolimus-eluting stent
The Xience stent family (Abbott vascular, California, United States of America), characterized by an L-605 cobalt-chromium (CoCr) is a thin-strut cobalt-chromium everolimus-eluting stent with an open-cell design containing a nonerodable polymer made of PBMA, a reservoir made of a fluorinated copolymer of vinylidene fluoride and hexafluoropropylene monomers. Xience™ stent family includes XIENCE Skypoint™ and XIENCE Sierra™

Drug:
• 1-month DAPT
DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Then, only the same oral P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor) up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC
• 12-month DAPT (Standard of care)
DAPT with acetylsalicylic acid and prasugrel or ticagrelor up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
iVascular S.L.U.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To determine the rate of Patient-Oriented Composite endpoint		1-2-3-4-5 years
Other	To determine the rate of individual components of All cause, cardiovascular, and cardiac death		1-2-3-4-5 years
Other	To determine the rate of recurrent myocardial infarction		1-2-3-4-5 years
Other	To determine the rate of target lesion revascularization		1-2-3-4-5 years
Other	To determine the rate of target vessel revascularization		1-2-3-4-5 years
Other	To determine the rate of stent thrombosis		1-2-3-4-5 years
Other	To determine the rate of clinical device success		Immediatly after the procedure
Other	To determine the rate of clinical procedural success		Immediatly after the procedure
Other	To determine the rate of bleeding events		1-2-3-4-5 years
Other	To determine the rate of net adverse clinical endpoints (NACE)		1-2-3-4-5 years
Other	To determine the rate of major adverse cardiac and cerebral events (MACCE)		1-2-3-4-5 years
Other	To determine the rate of transfusion rates		1-2-3-4-5 years
Other	To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study		1 year
Other	To determine the rate of adverse ischemic events at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study		1 year
Primary	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
Primary	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	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
Secondary	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