Clinical trial • Phase III • Cardiology
TICAGRELOR for Coronary artery disease
Phase III trial of TICAGRELOR for Coronary artery disease.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Coronary artery disease
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 03-06-2024
- First CTIS Authorization Date
- 25-09-2024
Trial design
ASA (aspirin) alone for 1 month; aspirin products listed in the application include Aspirin® protect 100 mg, Thrombo ASS 100 mg, Trombyl 75 mg (oral aspirin formulations).-controlled Phase III trial across 15 sites in Sweden, Austria, Germany.
- Comparator
- ASA (aspirin) alone for 1 month; aspirin products listed in the application include Aspirin® protect 100 mg, Thrombo ASS 100 mg, Trombyl 75 mg (oral aspirin formulations).
- Target Sample Size
- 450
- Trial Duration For Participant
- 1825
Eligibility
Recruits 450 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be able to sign informed consent ("Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years"). No pediatric or assent procedures are described..
- Pregnancy Exclusion
- Women of childbearing potential
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be able to sign informed consent ("Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years"). No pediatric or assent procedures are described.
Inclusion criteria
- {"criterion_text":"- Age ≥18 years"}
- {"criterion_text":"- Elective first-time CABG with use of ≥1 saphenous vein graft"}
- {"criterion_text":"- Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years"}
- {"criterion_text":"- Chronic coronary disease"}
Exclusion criteria
- {"criterion_text":"- Any indication for dual antiplatelet therapy, including •Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI) •Recent PCI requiring continuation of dual antiplatelet therapy after CABG"}
- {"criterion_text":"- Inability to undergo coronary computed tomographic angiography (CCTA)"}
- {"criterion_text":"- Participating in another investigational device or drug study within five times the half-life of the drug/metabolites"}
- {"criterion_text":"- Women of childbearing potential"}
- {"criterion_text":"- Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis"}
- {"criterion_text":"- Current or anticipated use of oral anticoagulation"}
- {"criterion_text":"- Paroxysmal, persistent or permanent atrial fibrillation"}
- {"criterion_text":"- Any concomitant cardiac or non-cardiac procedure"}
- {"criterion_text":"- Planned cardiac or non-cardiac surgery within one year"}
- {"criterion_text":"- Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy <5 years"}
- {"criterion_text":"- Inability to use the saphenous vein"}
- {"criterion_text":"- Contraindications to the use of aspirin"}
- {"criterion_text":"- Contraindications to the use of ticagrelor, including •Known hypersensitivity to ticagrelor •Active pathological bleeding (including, but not limited to gastrointestinal or intracranial bleeding) •History of intracranial hemorrhage •Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure assessed at 1 year.","definition_or_measurement_approach":"Hierarchical composite endpoint measuring time to events (death, stroke, MI, repeat revascularization, graft failure) assessed at 1 year."}
Secondary endpoints
- {"endpoint_text":"- The hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure assessed at 1 year.","definition_or_measurement_approach":"Hierarchical composite including BARC type 3 bleeding, measured as time-to-event and assessed at 1 year."}
- {"endpoint_text":"- The hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and 5-year time-averaged disease-specific (Seattle Angina Questionnaire [SAQ]-7) quality of life (QoL) score assessed at 5 years.","definition_or_measurement_approach":"Hierarchical composite including 5-year time-averaged SAQ-7 QoL score, assessed over 5 years."}
- {"endpoint_text":"- The hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score assessed at 5 years.","definition_or_measurement_approach":"Hierarchical composite including BARC type 3 bleeding and 5-year time-averaged SAQ-7 QoL, assessed over 5 years."}
Recruitment
- Planned Sample Size
- 450
- Recruitment Window Months
- 66
- Consent Approach
- Participants must be able to sign informed consent ("Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years"). Subject information and informed consent form documents for adults are listed (e.g. "L1_SIS and ICF adults_redacted"; German-specific ICF available: "L1_SIS and ICF adults_Germany_redacted"). No pediatric/assent forms described.
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 300
Sweden
- Earliest CTIS Part Ii Submission Date
- 18-06-2024
- Latest Decision Or Authorization Date
- 26-09-2024
- Processing Time Days
- 100
- Number Of Sites
- 2
- Number Of Participants
- 100
Sites
- Site Name
- Sahlgrenska University Hospital-Vastra Gotalandsregionen
- Department Name
- Sahlgrenska University Hospital, Department of Cardiothoracic Surgery
- Contact Person Name
- Anders Jeppson
- Contact Person Email
- anders.jeppsson@vgregion.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Skåne University Hospital Lund, Department of Cardiothoracic Surgery
- Contact Person Name
- Igor Zindovic
- Contact Person Email
- igor.zindovic@med.lu.se
Austria
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 517
- Number Of Sites
- 5
- Number Of Participants
- 100
Sites
- Site Name
- Medical University of Vienna
- Department Name
- Department of Cardiac Surgery
- Contact Person Name
- Sigrid Sandner
- Contact Person Email
- sigrid.sandner@meduniwien.ac.at
- Site Name
- Johannes Kepler University
- Department Name
- Department of Surgery Division of Cardiac Surgery
- Contact Person Name
- Andreas Zierer
- Contact Person Email
- andreas.zierer@kepleruniklinikum.at
- Site Name
- Medical University Of Graz
- Department Name
- Medical University Graz Department of Surgery Division of Cardiac Surgery
- Contact Person Name
- Igor Knez
- Contact Person Email
- igor.knez@medunigraz.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Medical University of Innsbruck, Department of Cardiac Surgery
- Contact Person Name
- Elfriede Ruttmann-Ulmer
- Contact Person Email
- elfriede.ruttmann@i-med.ac.at
- Site Name
- Noe LGA Gesundheit Region Mitte GmbH
- Department Name
- Department of Cardiac Surgery
- Contact Person Name
- Dominik Wiedemann
- Contact Person Email
- dominik.wiedemann@stpoelten.lknoe.at
Germany
- Earliest CTIS Part Ii Submission Date
- 19-07-2024
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 496
- Number Of Sites
- 8
- Number Of Participants
- 100
Sites
- Site Name
- TUM Klinikum Deutsches Herzzentrum
- Department Name
- TUM University Hospital German Heart Center, Department of Cardiovascular Surgery
- Contact Person Name
- Johannes Böhm
- Contact Person Email
- boehmj@dhm.mhn.de
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Clinic and Polyclinic for Thoracic, Cardiac, and Thoracic Vascular Surgery
- Contact Person Name
- Gloria Färber
- Contact Person Email
- Faerber_G@ukw.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- University of Freiburg, Department of Cardiac and Vascular Surgery
- Contact Person Name
- Alicja Zientara
- Contact Person Email
- alicja.zientara@uniklinik-freiburg.de
- Site Name
- Robert Bosch Gesellschaft fuer medizinische Forschung mbH
- Department Name
- Department of cardiovascular Surgery
- Contact Person Name
- Marc Albert
- Contact Person Email
- Marc.albert@rbk.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Department for Cardiac, Pediatruc Cardiac and Vascular Surgery
- Contact Person Name
- Andreas Böning
- Contact Person Email
- andreas.boening@chiru.med.uni-giessen.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Department of Cardiac Surgery
- Contact Person Name
- Alexander Assmann
- Contact Person Email
- Alexander.assmann@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Department for Cardiac and Thoracic Surgery
- Contact Person Name
- Matthias Thielmann
- Contact Person Email
- Matthias.Thielmann@uk-essen.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Department of Cardiac and Thoracic Surgery
- Contact Person Name
- Torsten Dönst
- Contact Person Email
- Doenst@med.uni-jena.de
Sponsor
Primary sponsor
- Full Name
- Weill Medical College Of Cornell University
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Brilique 90 mg film-coated tablets
- Active Substance
- TICAGRELOR
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation number: EU/1/10/655/001 (mrpNumber: EMEA/H/C/001241)
- Maximum Dose
- 180 mg (maxDailyDoseAmount)
- Investigational Product Name
- Aspirin® protect 100 mg Magensaftresistente Tablette Acetylsalicylsäure
- Active Substance
- ACETYLSALICYLIC ACID PH. EUR.
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation number: 16854.01.01 (authorisationCountryCode: DE)
- Maximum Dose
- 150 mg (maxDailyDoseAmount)
- Investigational Product Name
- Thrombo ASS 100 mg-Filmtabletten
- Active Substance
- ACETYLSALICYLIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation number: 1-19830 (authorisationCountryCode: AT)
- Maximum Dose
- 150 mg (maxDailyDoseAmount)
- Investigational Product Name
- Trombyl 75 mg tabletter
- Active Substance
- ACETYLSALICYLIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation number: 11423 (authorisationCountryCode: SE)
- Maximum Dose
- 150 mg (maxDailyDoseAmount)
- Combination Treatment
- Yes
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