Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
2,312
Countries
4
Sites
39
Coronary Artery Disease
- First co-primary objective of this study is to determine the rate of target lesion failure at 1-year between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group. Results related to each allocated device will be used …
Key facts
- Sponsor
- Ivascular S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 6 Oct 2023 → ongoing
- Decision date (initial)
- 2024-05-24
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- iVascular
External identifiers
- EU CT number
- 2023-507015-35-00
- EudraCT number
- 2021-003906-34
- ClinicalTrials.gov
- NCT05952206
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
- First co-primary objective of this study is to determine the rate of target lesion failure at 1-year between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group.
Results related to each allocated device will be used to address the Haute Autorité de santé (HAS) requirements.
- Second co-primary objective of the study is to determine the rate of clinically relevant bleeding events (Bleeding Academic Research Consortium 2, 3, or 5) at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy (tested for superiority of the experimental arm).
Secondary objectives 2
- 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).
- Rate of target lesion failure at 1-year between angiolite stent and Xience stent family (Skypoint or Sierra) (tested for non-inferiority) in the standard of care subgroup.
Conditions and MedDRA coding
Coronary Artery Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10011078 | Coronary artery disease | 100000004849 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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 10
- Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt
- 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
- Known stroke (any type) within the 30 days prior to the randomization
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Target lesion failure: cardiovascular death, target-vessel myocardial infarction, and target lesion revascularization (clinically driven) at 1-year follow-up.
- Adverse ischemic events: All-cause death, myocardial infarction, stroke, or urgent target vessel revascularization.
Secondary endpoints 1
- Ischemic event including all-cause death, non-fatal myocardial infarction, or stroke.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SCP163967 · ATC
- Active substance
- Acetylsalicylic Acid
- Substance synonyms
- ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC04 — CLOPIDOGREL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP11453711 · ATC
- Active substance
- Ticagrelor
- Substance synonyms
- AZD6140
- Route of administration
- ORAL
- Max daily dose
- 180 mg milligram(s)
- Max total dose
- 180 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC24 — TICAGRELOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP26720642 · ATC
- Active substance
- Acetylsalicylic Acid
- Substance synonyms
- ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP185074 · ATC
- Active substance
- Prasugrel
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — PRASUGREL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 6
SUB30898 · Substance
- Active substance
- Ticagrelor
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 180 mg milligram(s)
- Max total dose
- 180 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB30236 · Substance
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB30236 · Substance
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13395MIG · Substance
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13395MIG · Substance
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12730MIG · Substance
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ivascular S.L.
- Sponsor organisation
- Ivascular S.L.
- Address
- Nave 3, Cami De La Ca N'ubach No 11, Poligono Industrial Les Fallulles Cami De La Ca N'ubach No 11 Poligono Industrial Les Fallulles
- City
- Sant Vicenc Dels Horts
- Postcode
- 08620
- Country
- Spain
Scientific contact point
- Organisation
- Ivascular S.L.
- Contact name
- Clinical & Vigilance Affairs Director
Public contact point
- Organisation
- Ivascular S.L.
- Contact name
- Clinical & Vigilance Affairs Director
Locations
4 EU/EEA countries · 39 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 400 | 7 |
| France | Ongoing, recruitment ended | 220 | 4 |
| Germany | 0 | 2 | |
| Spain | Ongoing, recruitment ended | 1,692 | 26 |
| Rest of world | — | 0 | — |
Investigational sites
CHU Mons University Clinic
Cardiology, Université de Mons Faculté de Médecine et de Pharmacie Service de Cardiologie, Pentagone, Mons
Hôpital de la Citadelle
Cardiology, Hôpital de la Citadelle, Boulevard du 12e de Ligne, 4000 Liège
Imelda Hospital Bonheiden
Cardiology, interventional Cardiology, Imelda Hospital, Bonheiden
HC Marie Curie
Cardiology, Hôpital Civil Marie Curie, 140, Charleroi
AZ Turnhout
Cardiology, Rubensstraat 166, 2300, Turnhout
CHC MontLegia
Cardiology, Boulev. De Patience Et Beajonc 2, 4000, Liege
AZ Delta uw Ziekenhuis Campus Rumbeke, campus Brugsesteenweg Roeselare
Cardiology, AZ Delta Campus, campus Brugsesteenweg, Roselare
Hopital Jaques Cartier Massy
Cardiologie, avenue du Noyer Lambert 6, 91300, Massy
Hotel Prive Claude Galien, Quincy Sous
Cardiologie, route de boussy, 91480, quincy sous senart
CHU De Toulouse -Hopital Rangueil
Cardiologie, 1 Avenue du Professeur Jean Poulhès, Service Cardiologie B. Pr CARRIE, Toulouse
Centre Hospitalier Universitaire De Lille
Cardiologie, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Ziekenhuis Oost-Limburg Genk
Cardiology, Ziekenhuis Oost-Limburg, Synaps Park 1, Genk
Hartcentrum OLV Aalst
Cardiology, OLV Aalst Hartcentrum, Moorselbaan 164, Aalst
Hospital Universitario Y Politecnico La Fe
Cardiology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario 12 De Octubre
Cardiology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinico Universitario De Valladolid
Cardiology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Universitario Regional De Malaga
Cardiology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario De Leon
Cardiology, C Altos De Nava S/n, 24071, Leon
Hospital De Jerez De La Frontera
Cardiology, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Germans Trias I Pujol
Cardiology, Carretera Canyet 1a Planta, 08916, Badalona
Complexo Hospitalario Universitario De Santiago
Cardiology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Bellvitge University Hospital
Cardiology, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Universitario De Navarra
Cardiology, Irunlarrea Kalea 3, 31008, Pamplona
University Clinical Hospital Virgen De La Arrixaca
Cardiology, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario Juan Ramon Jimenez
Cardiology, Ronda Exterior Norte S/n, 21005, Huelva
University Hospital Son Espases
Cardiology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Puerta De Hierro De Majadahonda
Cardiology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitario Torrecardenas
Cardiology, Calle Paraje Torrecardenas S/n, 04009, Almeria
Hospital San Pedro De Alcantara
Cardiology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Clinico Universitario De Valencia
Cardiology, Avenida Blasco Ibanez 17, 46010, Valencia
El Hospital Universitario De Gran Canaria Dr. Negrin
Cardiology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitari Vall D Hebron
Cardiology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Virgen De La Victoria
Cardiology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Unviersitario Miguel Servet
Cardiology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital De La Santa Creu I Sant Pau
Cardiology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Marques De Valdecilla
Cardiology, Avenida Valdecilla Sn, 39008, Santander
Complexo Hospitalario Universitario De Vigo
Cardiology, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital Clinic De Barcelona
Cardiology, Calle Villarroel 170, 08036, Barcelona
Complexo Hospitalario Universitario A Coruna
Cardiology, Lugar Jubias De Arriba 84, 15006, A Coruna
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-06-25 | 2024-06-25 | 2026-01-13 | ||
| France | 2024-11-12 | 2024-11-21 | 2026-01-12 | ||
| Spain | 2023-10-06 | 2023-10-13 | 2026-01-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 40 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-507015-35 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_2023-507015-35 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC FR_Prasugrel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC FR_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC FR_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC FR_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC FR_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC FR_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AAS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AAS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_BE_Ge_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_BE_Ge_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_BE_Ge_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_BE_Ge_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_BE_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_BE_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_BE_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_BE_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Brilique_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Brilique_Ticagrelor | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_FR_clopidogrel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Plavix_Clopidogrel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Plavix_Clopidogrel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Prasugrel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Prasugrel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2-SMPC_BE ASS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2-SMPC_BE ASS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2-SMPC_BE ASS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2-SMPC_BE ASS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2-SMPC_FR ASS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2-SMPC_FR ASS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2-SMPC_FR ASS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2-SMPC_FR ASS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2-SMPC_FR ASS | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_2023-507015-35 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_2023-507015-35 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_2023-507015-35 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2023-507015-35 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-507015-35 | 4.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-23 | Spain | Acceptable 2023-10-04
|
2023-10-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-21 | Spain | Acceptable 2024-03-08
|
2024-03-08 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-03-21 | 2024-05-24 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-03-21 | 2024-06-14 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-12 | Spain | Acceptable 2024-09-09
|
2024-09-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-13 | Spain | Acceptable | 2025-12-17 |