Clinical trial
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy. A 2x2 Factorial, All-comer, Multicenter, Randomized Controlled Trial: ANGIODAPT
Name
ANGIODAPT-01
Description
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.
Trial arms
Trial start
2023-07-01
Estimated PCD
2025-07-01
Trial end
2029-07-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Angiolite and abbreviated DAPT, Angiolite and standard of care DAPT
Other names:
iVascular angiolite
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™
Arms:
Xience stent family and abbreviated DAPT, Xience stent family and standard of care DAPT
Other names:
Xience stent family
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
Arms:
Angiolite and abbreviated DAPT, Xience stent family and abbreviated DAPT
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
Arms:
Angiolite and standard of care DAPT, Xience stent family and standard of care DAPT
Size
2312
Primary endpoint
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
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Phase III, prospective, randomized (1:1:1:1), factorial design 2x2, active control, patient-observer blinded and multicentre clinical trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Masking:\n\n* Patient-observer blinded for the stent type allocation.\n* Open-label for the antiplatelet regimen', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2312, 'type': 'ESTIMATED'}}
Updated at
2023-07-19
1 organization
2 products
1 indication
Organization
Ivascular S.L.U.Product
1-month DAPTIndication
Coronary Artery DiseaseProduct
12-month DAPT