Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
700
Countries
1
Sites
60
Spontaneous Coronary Artery Dissection.
To assess the efficacy of medical therapy (β-blockers and antiplatelet agents) in patients with Spontaneous Coronary Artery Dissection (SCAD).
Key facts
- Sponsor
- Spanish Society Of Cardiology, Spanish Society Of Cardiology, Spanish Society Of Cardiology
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 28 Sep 2021 → ongoing
- Decision date (initial)
- 2024-07-16
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Spanish Society of Cardiology (SEC)
External identifiers
- EU CT number
- 2024-516039-28-00
- EudraCT number
- 2021-001905-66
- ClinicalTrials.gov
- NCT04850417
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the efficacy of medical therapy (β-blockers and antiplatelet agents) in patients with Spontaneous Coronary Artery Dissection (SCAD).
Secondary objectives 7
- Angiographic and Quantitative Coronary Analyses (QCA).
- Coronary revascularization (selection of ideal candidates and optimization of results of coronary interventions).
- Intracoronary imaging (optical coherence tomography [OCT] and intravascular ultrasound [IVUS].
- Cardiac CT.
- Magnetic resonance imaging (MRI).
- Pharmacogenetics.
- Inflammatory, immunologic, genetic and micro-RNA analyses.
Conditions and MedDRA coding
Spontaneous Coronary Artery Dissection.
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomized controlled pragmatic trial using a 2x2 factorial design. Low-intervention clinical trial. Randomization (1:1/1:1) using a 2x2 factorial design:
- Prolonged therapy with β-blockers vs No β-blockers
- 1-month single antiplatelet therapy vs 12-month dual antiplatelet therapy.
Patients receiving dual antiplatelet therapy during the first year will be assigned, after the first year, to aspirin alone or clopidogrel alone indefinitely.
|
Randomised Controlled | None | β-blockers vs No β-blockers: β-blockers vs No β-blockers 1-month single antiplatelet therapy vs 12-month dual antiplatelet therapy.: 1-month single antiplatelet therapy vs 12-month dual antiplatelet therapy. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Written informed consent.
- Patients admitted for ACS or any other manifestation of myocardial ischemia.
- Diagnosis of SCAD on a coronary angiography during index hospitalization.
Exclusion criteria 5
- Cardiogenic shock or severe hemodynamic instability.
- Concomitant severe heart disease requiring surgical correction (in <2 years).
- Any major medical condition seriously limiting life expectancy (<2 years).
- Pregnant or breastfeeding women. Child-bearing age women participating in the study will be advised to use a highly effective contraceptive method considering the high-risk of recurrent SCAD associated with pregnancy.
- Participation in another clinical trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- A combined clinical endpoint including death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure at 1-year follow-up.
Secondary endpoints 3
- a secondary combined clinical endpoint (composite of death, MI, stroke, coronary revascularization, and recurrent dissection, hospital admission for ACS –with dynamic ECG changes- or heart failure or bleeding) will be used to assess the “net clinical benefit” of the antiplatelet strategy.
- Bleeding will be also analyzed as a separate safety secondary endpoint. Bleeding will be defined according to BARC definitions.
- Individual components of the primary endpoint will be assessed as secondary endpoints. Besides, a major predefined secondary combined endpoint will be the composite outcome measure of “hard” clinical events (including death, MI, stroke, recurrent dissection and coronary revascularization) and the combined outcome measure of death and MI alone.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
SCP131039 · ATC
- Active substance
- Carbasalate Calcium
- Substance synonyms
- Carbaspirin calcium
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 109500 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
SCP1160479 · ATC
- Active substance
- Atenolol
- Substance synonyms
- 2-[4-[2-HYDROXY-3-(PROPAN-2-YLAMINO)PROPOXY]PHENYL]ACETAMIDE
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 36500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AB03 — ATENOLOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP109534428 · ATC
- Active substance
- Bisoprolol Fumarate
- Substance synonyms
- BUT-2-ENEDIOIC ACID: 1-(PROPAN-2-YLAMINO)-3-[4-(2-PROPAN-2-YLOXYETHOXYMETHYL)PHENOXY]PROPAN-2-OL
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3650 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AB07 — BISOPROLOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP126600 · ATC
- Active substance
- Perindopril Tert-Butylamine
- Substance synonyms
- PERINDOPRIL ERBUMINE
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 36500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AG02 — CARVEDILOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1108233 · ATC
- Active substance
- Telmisartan
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 109500 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
SCP1159601 · ATC
- Active substance
- Metoprolol Succinate
- Substance synonyms
- BUTANEDIOIC ACID, 1-[4-(2-METHOXYETHYL)PHENOXY]-3-(PROPAN-2-YLAMINO)PROPAN-2-OL
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 146000 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AB02 — METOPROLOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP185072 · ATC
- Active substance
- Prasugrel Hydrobromide
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 21900 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
SCP129860 · ATC
- Active substance
- Propranolol Hydrochloride
- Substance synonyms
- PROPRANOLOLI HYDROCHLORIDUM, PROPRANOLOL HYDROCHLORIIDE, 1-NAPHTHALEN-1-YLOXY-3-(PROPAN-2-YLAMINO)PROPAN-2-OL HYDROCHLORIDE
- Route of administration
- ORAL
- Max daily dose
- 640 mg milligram(s)
- Max total dose
- 233600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AA05 — PROPRANOLOL
- 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
- 65700 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Spanish Society Of Cardiology
- Sponsor organisation
- Spanish Society Of Cardiology
- Address
- Calle Nuestra Senora De Guadalupe 5-7
- City
- Madrid
- Postcode
- 28028
- Country
- Spain
Scientific contact point
- Organisation
- Spanish Society Of Cardiology
- Contact name
- Fernando Alfonso
Public contact point
- Organisation
- Spanish Society Of Cardiology
- Contact name
- Spanish Society of Cardiology (SEC)
Spanish Society Of Cardiology
- Sponsor organisation
- Spanish Society Of Cardiology
- Address
- Calle Nuestra Senora De Guadalupe 5-7
- City
- Madrid
- Postcode
- 28028
- Country
- Spain
Spanish Society Of Cardiology
- Sponsor organisation
- Spanish Society Of Cardiology
- Address
- Calle Nuestra Senora De Guadalupe 5-7
- City
- Madrid
- Postcode
- 28028
- Country
- Spain
Locations
1 EU/EEA country · 60 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 700 | 60 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Puerta Del Mar
Cardiology, Avenida De Ana De Viya 21, 11009, Cadiz
Hospital Universitario Reina Sofia
Cardiology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Juan Ramon Jimenez
Cardiology, Ronda Exterior Norte S/n, 21005, Huelva
Hospital Universitario Virgen De Las Nieves
Cardiology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario Virgen De La Victoria
Cardiology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Miguel Servet
Cardiology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario De Cabuenes
Cardiology, Calle Prados 395, Cabuenes, Gijon
Hospital Universitario Central De Asturias
Cardiology, Avenida De Roma S/n, 33011, Oviedo
University Hospital Son Espases
Cardiology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario De Canarias
Cardiology, Carretera Ofra S/N, 38320, San Cristobal De La Laguna
Hospital Universitario Marques De Valdecilla
Cardiology, Avenida Valdecilla Sn, 39008, Santander
Hospital General Universitario De Albacete
Cardiology, Calle Hermanos Falco 37, 02006, Albacete
Hospital General Universitario De Ciudad Real
Cardiology, Calle Del Obispo Rafael Torija S/n, 13005, Ciudad Real
Hospital Universitario De Toledo
Cardiology, Avenue Del Rio Guadiana Sn, 45007, Toledo
Hospital Universitario De Salamanca
Cardiology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Clinico Universitario De Valladolid
Cardiology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Germans Trias I Pujol
Cardiology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Clinic De Barcelona
Cardiology, Calle Villarroel 170, 08036, Barcelona
Hospital Del Mar
Cardiology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario De Leon
Cardiology, Calle Altos De Nava S/n, 24071, Leon
Hospital De La Santa Creu I Sant Pau
Cardiology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitari Vall D Hebron
Cardiology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Bellvitge University Hospital
Cardiology, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital General Universitario Dr. Balmis
Cardiology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario Y Politecnico La Fe
Cardiology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario De Badajoz
Cardiology, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario De Caceres
Cardiology, Avenida De La Universidad 75, 10004, Caceres
Complexo Hospitalario Universitario A Coruna
Cardiology, Lugar Jubias De Arriba 84, 15006, A Coruna
Complexo Hospitalario Universitario De Santiago
Cardiology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario De La Princesa
Cardiology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Clinico San Carlos
Cardiology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital General Universitario Gregorio Maranon
Cardiology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario 12 De Octubre
Cardiology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario La Paz
Cardiology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Ramon Y Cajal
Cardiology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Cardiology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Cardiology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario De Torrejon
Cardiology, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
University Clinical Hospital Virgen De La Arrixaca
Cardiology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Policlinica Gipuzkoa S.A.
Cardiology, Paseo Miramon 174, 20009, Donostia
Hospital Alvaro Cunqueiro
Cardiology, Estrada Clara Campoamor No 341, 36312, Vigo
University Hospital Virgen Del Rocio S.L.
Cardiology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitari Joan XXIII De Tarragona
Cardiology, Calle Del Doctor Mallafre Guasch 4, 43005, Tarragona
El Hospital Universitario De Gran Canaria Dr. Negrin
Cardiology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Complejo Hospitalario Universitario Insular Materno Infantil
Cardiology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario Torrecardenas
Cardiology, Calle Paraje Torrecardenas S/n, 04009, Almeria
Hospital Universitario Regional De Malaga
Cardiology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario De Navarra
Cardiology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario Virgen De La Macarena
Cardiology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinico Universitario Lozano Blesa
Cardiology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitari De Girona Doctor Josep Trueta
Cardiology, Avinguda De Franca S/n, 17007, Girona
Hospital De Jerez De La Frontera
Cardiology, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Universitario Lucus Augusti
Cardiology, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital Universitario De Jaen
Cardiology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario Basurto
Cardiology, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitario De Cruces
Cardiology, Cruces Plaza S/n, 48903, Barakaldo
Hospital General Universitario De Castellon
Cardiology, Avenida De Benicasim S/n, 12004, Castello De La Plana
Hospital Universitario Clinico San Cecilio
Cardiology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario San Juan De Alicante
Cardiology, Carretera N-332 Alicante-Valencia S/n, 03550, Sant Joan D'alacant
Hospital Clinico Universitario De Valencia
Cardiology, Avenida Blasco Ibanez 17, 46010, Valencia
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 |
|---|---|---|---|---|---|
| Spain | 2021-09-28 | 2021-09-28 | 2025-02-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | BA-SCAD Protocol | 2 |
| Recruitment arrangements (for publication) | Document NA | 1 |
| Subject information and informed consent form (for publication) | BA-SCAD PIS-ICF | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Clopidogrel | 1 |
| Synopsis of the protocol (for publication) | BA-SCAD Protocol summary | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-09 | Spain | Acceptable with conditions 2024-07-16
|
2024-07-16 |