Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
NCT05952206
Phase
Phase 3
Recruitment status
Active, not recruiting
Participants
2,312
Lead sponsor
iVascular S.L.U.
Start date
2023-10-13
Number of sites
- Summary
- Factorial 2x2, all-comer, multicentre, 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 open-label for the stent type and the antiplatelet regimen.
- Acronym
- ANGIODAPT
- Short title
- Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2030-01-13
- First posted
- 2023-07-19
- Registry last updated
- 2026-05-15
- Primary completion date
- 2027-01-13
- Start date
- 2023-10-13
- Actual participants
- 2,312
- Participants
- 2,312
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- 1:1:1:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- iVascular S.L.U.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05952206
- ClinicalTrials.gov ID
- NCT05952206
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Factorial
- Purpose
- Treatment
- Masking
- No masking
- Masking description
- Masking: * Open-label for the stent type * Open-label for the antiplatelet regimen
Sources for study design
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.
Timeframe: 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).
Timeframe: 1 year
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).
Timeframe: 1 year
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.
Timeframe: 1 year
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 95 Years
- Healthy volunteers
- No
- 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 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.
Sources for eligibility
- IMELDABonheiden, Belgium
- CHU Marie CurieCharleroi, Belgium
- ZOL GENKGenk, Belgium
- CHC MontlégiaLiège, Belgium
- Hospital de La CitadelleLiège, Belgium
- Chu Ambroise PareMons, Belgium
- Az DeltaRoeselare, Belgium
- Az TurnhoutTurnhout, Belgium
- Chu LilleLille, France
- Icps MassyMassy, France
- Ipcs QuincyQuincy-sous-Sénart, France
- Chu ToulouseToulouse, France
- Complejo Hospitalario Universitario A CoruñaA Coruña, Spain
- Complejo Hospitalario TorrecárdenasAlmería, Spain
- Hospital Clínic de BarcelonaBarcelona, Spain
- Hospital de La Santa Creu I Sant PauBarcelona, Spain
- Hospital Germans Trias I PujolBarcelona, Spain
- Hospital Universitario de BellvitgeBarcelona, Spain
- Hospital Universitario Vall D'HebrónBarcelona, Spain
- Hospital San Pedro de AlcantaraCáceres, Spain
- Hospital Universitario Juan Ramón JiménezHuelva, Spain
- Hospital Universitario Jerez de La FronteraJerez de la Frontera, Spain
- Hospital Universitario de Gran Canaria Doctor NegrínLas Palmas de Gran Canaria, Spain
- Hospital Universitario de LeónLeón, Spain
- Hospital Universitario 12 de OctubreMadrid, Spain
And 13 more, listed on the interactive page.
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Coronary artery disorder Primary condition