Clinical trial • Phase IV • Cardiology
clopidogrel for Acute coronary syndrome | Cardiovascular diseases
Phase IV trial of clopidogrel for Acute coronary syndrome | Cardiovascular diseases.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Acute coronary syndrome | Cardiovascular diseases
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 17-03-2024
- First CTIS Authorization Date
- 03-04-2024
Trial design
Brilique 90 mg film-coated tablets (ticagrelor), oral; Efient 10 mg film-coated tablets (prasugrel), oral. Doses provided; schedule not specified.-controlled Phase IV trial across 21 sites in Spain.
- Comparator
- Brilique 90 mg film-coated tablets (ticagrelor), oral; Efient 10 mg film-coated tablets (prasugrel), oral. Doses provided; schedule not specified.
- Biomarker Stratified
- True, VerifyNow platelet aggregation/reactivity measurement (used to guide de-escalation); specific strata not specified
- Target Sample Size
- 634
- Trial Duration For Participant
- 365
Eligibility
Recruits 634 No vulnerable population selected; participants must be ≥18 years and provide written informed consent..
- Pregnancy Exclusion
- Patient is pregnant or breast feeding
- Vulnerable Population
- No vulnerable population selected; participants must be ≥18 years and provide written informed consent.
Inclusion criteria
- {"criterion_text":"- Patients with age 18 years or above"}
- {"criterion_text":"- Patient is able to understand the nature of study and has provided written informed consent"}
- {"criterion_text":"- Patients with Acute Coronary Syndrome and who underwent PCI during the admission with absorbable polymer stent who have been discharged on double antiplatelet therapy with Acetylsalicylic Acid and Ticagrelor or Prasugrel"}
Exclusion criteria
- {"criterion_text":"- Patients with history of intracranial bleeding"}
- {"criterion_text":"- Patients with contraindication for the use of Acetylsalicylic Acid or Clopidogrel or Ticagrelor or Prasugrel"}
- {"criterion_text":"- Patients with major ischemic or hemorrhagic events during the first month"}
- {"criterion_text":"- Patients with Thrombocytopenia <50,000 /μL"}
- {"criterion_text":"- Patients with permanent oral anticoagulation"}
- {"criterion_text":"- Patient is pregnant or breast feeding"}
- {"criterion_text":"- Patients with impossibility to complete 1 year of follow-up"}
- {"criterion_text":"- Patient´s life-expectancy is less than 24 months"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of Net Adverse Cardiac Events (NACE). Net Adverse Cardiac Events, defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, Bleeding BARC type ≥ 2. At 12 months","definition_or_measurement_approach":"Net Adverse Cardiac Events defined as a composite of death from vascular causes (cardiovascular or cerebrovascular and any death without another known cause), non-fatal MI, non-fatal stroke, and Bleeding BARC type ≥2, assessed at 12 months."}
Secondary endpoints
- {"endpoint_text":"- Incidence of Death (Cardiovascular) at 12 months","definition_or_measurement_approach":"Incidence of cardiovascular death assessed at 12 months"}
- {"endpoint_text":"- Incidence of Death at 12 months","definition_or_measurement_approach":"All-cause mortality assessed at 12 months"}
- {"endpoint_text":"- Incidence of Non fatal Myocardial Infarction (MI) at 12 months","definition_or_measurement_approach":"Incidence of non-fatal MI assessed at 12 months"}
- {"endpoint_text":"- Incidence of Stroke at 12 months","definition_or_measurement_approach":"Incidence of stroke assessed at 12 months"}
- {"endpoint_text":"- Incidence of Thrombosis in target lesion, at 12 months","definition_or_measurement_approach":"Incidence of target lesion thrombosis assessed at 12 months"}
- {"endpoint_text":"- Incidence of revascularization on target lesion at 12 months","definition_or_measurement_approach":"Incidence of unscheduled revascularization of target lesion assessed at 12 months"}
- {"endpoint_text":"- Incidence of (BARC criteria ≥ 2) at 12 months","definition_or_measurement_approach":"Incidence of bleeding events meeting BARC criteria ≥2 assessed at 12 months"}
Recruitment
- Planned Sample Size
- 634
- Recruitment Window Months
- 53
- Consent Approach
- Written informed consent provided by participant (patients ≥18 years). No information provided on assent or languages.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 634
Spain
- Earliest CTIS Part Ii Submission Date
- 02-04-2024
- Latest Decision Or Authorization Date
- 03-04-2024
- Processing Time Days
- 1
- Number Of Sites
- 21
- Number Of Participants
- 634
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- ANA BELEN CID ALVAREZ
- Principal Investigator Email
- belcid77@hotmail.com
- Contact Person Name
- ANA BELEN CID ALVAREZ
- Contact Person Email
- belcid77@hotmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- RAMON LOPEZ PALOP
- Principal Investigator Email
- ramonlopezpalop@gmail.com
- Contact Person Name
- RAMON LOPEZ PALOP
- Contact Person Email
- ramonlopezpalop@gmail.com
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- JOSE GABRIEL GALACHE OSUNA
- Principal Investigator Email
- jggalacheo@gmail.com
- Contact Person Name
- JOSE GABRIEL GALACHE OSUNA
- Contact Person Email
- jggalacheo@gmail.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- ALEJANDRO DIEGO NIETO
- Principal Investigator Email
- adiegonieto@gmail.com
- Contact Person Name
- ALEJANDRO DIEGO NIETO
- Contact Person Email
- adiegonieto@gmail.com
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- JOSE ANTONIO LINARES VICENTE
- Principal Investigator Email
- joselinares1979@hotmail.com
- Contact Person Name
- JOSE ANTONIO LINARES VICENTE
- Contact Person Email
- joselinares1979@hotmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- JOSE MARIA DE LA TORRE HERNANDEZ
- Principal Investigator Email
- chematorre60@gmail.com
- Contact Person Name
- JOSE MARIA DE LA TORRE HERNANDEZ
- Contact Person Email
- chematorre60@gmail.com
- Site Name
- Hospital De Galdakao Usansolo
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- JOSE RAMON RUMOROSO CUEVAS
- Principal Investigator Email
- JOSERAMON.RUMOROSOCUEVAS@osakidetza.eus
- Contact Person Name
- JOSE RAMON RUMOROSO CUEVAS
- Contact Person Email
- JOSERAMON.RUMOROSOCUEVAS@osakidetza.eus
- Site Name
- Hospital Del Mar
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- BEATRIZ VAQUERIZO MONTILLA
- Principal Investigator Email
- beavaquerizo@yahoo.es
- Contact Person Name
- BEATRIZ VAQUERIZO MONTILLA
- Contact Person Email
- beavaquerizo@yahoo.es
- Site Name
- Hospital Universitario De Cabuenes
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- IÑIGO LOZANO MARTINEZ-LUENGAS
- Principal Investigator Email
- inigo.lozano@gmail.com
- Contact Person Name
- IÑIGO LOZANO MARTINEZ-LUENGAS
- Contact Person Email
- inigo.lozano@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- RAUL MORENO GOMEZ
- Principal Investigator Email
- raulmorenog@hotmail.com
- Contact Person Name
- RAUL MORENO GOMEZ
- Contact Person Email
- raulmorenog@hotmail.com
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- VICENTE ALCALDE MARTINEZ
- Principal Investigator Email
- vicentefalcalde@gmail.com
- Contact Person Name
- VICENTE ALCALDE MARTINEZ
- Contact Person Email
- vicentefalcalde@gmail.com
- Site Name
- Hospital General Universitario De Albacete
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- JUAN CORDOBA SORIANO
- Principal Investigator Email
- jgcordobas@hotmail.com
- Contact Person Name
- JUAN CORDOBA SORIANO
- Contact Person Email
- jgcordobas@hotmail.com
- Site Name
- Bellvitge University Hospital
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- JOSE LUIS FERREIRO GONZALEZ
- Principal Investigator Email
- ferreiroeap@gmail.com
- Contact Person Name
- JOSE LUIS FERREIRO GONZALEZ
- Contact Person Email
- ferreiroeap@gmail.com
- Site Name
- Area De Salud De Leon Y El Bierzo
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- ARMANDO PEREZ DE PRADO
- Principal Investigator Email
- aperez@secardiologia.es
- Contact Person Name
- ARMANDO PEREZ DE PRADO
- Contact Person Email
- aperez@secardiologia.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- IRURUETA
- Principal Investigator Name
- IMANOL OTAEGUI
- Principal Investigator Email
- iotaegui@hotmail.com
- Contact Person Name
- IMANOL OTAEGUI
- Contact Person Email
- iotaegui@hotmail.com
- Site Name
- Hospital Universitario Lucus Augusti
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- RAYMUNDO OCARANZA SANCHEZ
- Principal Investigator Email
- rayocaranza@gmail.com
- Contact Person Name
- RAYMUNDO OCARANZA SANCHEZ
- Contact Person Email
- rayocaranza@gmail.com
- Site Name
- Hospital General Universitario De Ciudad Real
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- IGNACIO SANCHEZ PEREZ
- Principal Investigator Email
- Ignaciosperez@yahoo.es
- Contact Person Name
- IGNACIO SANCHEZ PEREZ
- Contact Person Email
- Ignaciosperez@yahoo.es
- Site Name
- Hospital Universitario Juan Ramon Jimenez
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- ANTONIO GOMEZ MENCHERO
- Principal Investigator Email
- aegmenchero@hotmail.com
- Contact Person Name
- ANTONIO GOMEZ MENCHERO
- Contact Person Email
- aegmenchero@hotmail.com
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- FRANCISCO JAVIER FERNANDEZ PORTALES
- Principal Investigator Email
- portales70@hotmail.com
- Contact Person Name
- FRANCISCO JAVIER FERNANDEZ PORTALES
- Contact Person Email
- portales70@hotmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- CRISTOBAL URBANO CARRILLO
- Principal Investigator Email
- cristobalurbano@gmail.com
- Contact Person Name
- CRISTOBAL URBANO CARRILLO
- Contact Person Email
- cristobalurbano@gmail.com
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- CARDIOLOGY
- Principal Investigator Name
- IGNACIO AMAT SANTOS
- Principal Investigator Email
- ijamat@gmail.com
- Contact Person Name
- IGNACIO AMAT SANTOS
- Contact Person Email
- ijamat@gmail.com
Sponsor
Primary sponsor
- Full Name
- Fundacion Epic
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Plavix 75 mg film-coated tablets
- Active Substance
- clopidogrel
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: EU/1/98/069/001)
- Starting Dose
- 75 mg
- Dose Levels
- 75 mg
- Maximum Dose
- 75
- Investigational Product Name
- Brilique 90 mg film-coated tablets
- Active Substance
- ticagrelor
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: EU/1/10/655/002)
- Starting Dose
- 90 mg
- Dose Levels
- 90 mg
- Maximum Dose
- 180
- Investigational Product Name
- Efient 10 mg film-coated tablets.
- Active Substance
- prasugrel
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: EU/1/08/503/014)
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
- Maximum Dose
- 10
- Combination Treatment
- Yes
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