The One-Month DAPT with Ticagrelor In CABG PatieNts Trial (ODIN)

2023-506613-22-00 Protocol ODIN Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 25 Sep 2024 · Status Ongoing, recruiting · 3 EU/EEA countries · 15 sites · Protocol ODIN

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 750
Countries 3
Sites 15

coronary artery disease

To compare the effect of ticagrelor in addition to ASA versus ASA alone for 1 month on the 1-year incidence of ischemic events and graft failure among patients undergoing CABG for SIHD.

Key facts

Sponsor
Weill Medical College Of Cornell University
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
25 Sep 2024 → ongoing
Decision date (initial)
2024-09-29
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Canadian Institutes of Health Research (CIHR)

External identifiers

EU CT number
2023-506613-22-00
ClinicalTrials.gov
NCT05997693

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Prophylaxis

To compare the effect of ticagrelor in addition to ASA versus ASA alone for 1 month on the 1-year incidence of ischemic events and graft failure among patients undergoing CABG for SIHD.

Secondary objectives 1

  1. To determine the net effect of ticagrelor in addition to ASA versus ASA alone for 1 month on the 1-year incidence of ischemic events, graft failure and major bleeding events.

Conditions and MedDRA coding

coronary artery disease

VersionLevelCodeTermSystem organ class
20.0 PT 10011078 Coronary artery disease 100000004849

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Age ≥18 years
  2. Elective first-time CABG with use of ≥1 saphenous vein graft
  3. Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years
  4. Chronic coronary disease

Exclusion criteria 13

  1. 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
  2. Current or anticipated use of oral anticoagulation
  3. Paroxysmal, persistent or permanent atrial fibrillation
  4. Any concomitant cardiac or non-cardiac procedure
  5. Planned cardiac or non-cardiac surgery within one year
  6. Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy <5 years
  7. Inability to use the saphenous vein
  8. Contraindications to the use of aspirin
  9. 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)
  10. Inability to undergo coronary computed tomographic angiography (CCTA)
  11. Participating in another investigational device or drug study within five times the half-life of the drug/metabolites
  12. Women of childbearing potential
  13. Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure assessed at 1 year.

Secondary endpoints 3

  1. 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.
  2. 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.
  3. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Brilique 90 mg film-coated tablets

PRD3534514 · Product

Active substance
Ticagrelor
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
180 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
B01AC24 — -
Marketing authorisation
EU/1/10/655/001
MA holder
ASTRAZENECA AB
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 3

Thrombo ASS 100 mg-Filmtabletten

PRD2842563 · Product

Active substance
Acetylsalicylic Acid
Pharmaceutical form
GASTRO-RESISTANT TABLET
Route of administration
ORAL USE
Max daily dose
150 mg milligram(s)
Max total dose
4500 mg milligram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
B01AC06 — ACETYLSALICYLIC ACID
Marketing authorisation
1-19830
MA holder
G.L. PHARMA GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Aspirin® protect 100 mg Magensaftresistente Tablette Acetylsalicylsäure

PRD393800 · Product

Active substance
Acetylsalicylic Acid Ph. Eur.
Pharmaceutical form
GASTRO-RESISTANT TABLET
Route of administration
ORAL USE
Max daily dose
150 mg milligram(s)
Max total dose
4500 mg milligram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
B01AC06 — ACETYLSALICYLIC ACID
Marketing authorisation
16854.01.01
MA holder
BAYER VITAL GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Trombyl 75 mg tabletter

PRD411504 · Product

Active substance
Acetylsalicylic Acid
Substance synonyms
ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
150 mg milligram(s)
Max total dose
4500 mg milligram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
B01AC06 — ACETYLSALICYLIC ACID
Marketing authorisation
11423
MA holder
PFIZER AB
MA country
Sweden
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Weill Medical College Of Cornell University

Sponsor organisation
Weill Medical College Of Cornell University
Address
515 East 71st Street
City
New York
Postcode
10021-4873
Country
United States

Scientific contact point

Organisation
Weill Medical College Of Cornell University
Contact name
Research Program Specialist

Public contact point

Organisation
Weill Medical College Of Cornell University
Contact name
Research Program Specialist

Locations

3 EU/EEA countries · 15 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruiting 100 5
Germany Ongoing, recruiting 100 8
Sweden Ongoing, recruiting 100 2
Rest of world
United States, China, Canada
 — 450 —

Investigational sites

Austria

5 sites · Ongoing, recruiting
Noe LGA Gesundheit Region Mitte GmbH
Department of Cardiac Surgery, Dunant-Platz 1, 3100, St. Poelten
Medizinische Universitaet Innsbruck
Medical University of Innsbruck, Department of Cardiac Surgery, Anichstrasse 35, 6020, Innsbruck
Medical University Of Graz
Medical University Graz Department of Surgery Division of Cardiac Surgery, Neue Stiftingtalstrasse 6, 8010, Graz
Johannes Kepler University
Department of Surgery Division of Cardiac Surgery, Altenberger Strasse 69, 4040, Linz
Medical University of Vienna
Department of Cardiac Surgery, Waehringer Guertel 18-20, Alsergrund, Vienna

Germany

8 sites · Ongoing, recruiting
Universitaetsklinikum Essen AöR
Department for Cardiac and Thoracic Surgery, Hufelandstrasse 55, Holsterhausen, Essen
Justus-Liebig-Universitaet Giessen
Department for Cardiac, Pediatruc Cardiac and Vascular Surgery, Rudolf-Buchheim-Strasse 7, 35392, Giessen
Universitaetsklinikum Jena KöR
Department of Cardiac and Thoracic Surgery, Am Klinikum 1, Lobeda, Jena
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department of cardiovascular Surgery, Auerbachstrasse 112, Bad Cannstatt, Stuttgart
Universitaetsklinikum Duesseldorf AöR
Department of Cardiac Surgery, Moorenstrasse 5, Bilk, Duesseldorf
Medical Center - University Of Freiburg
University of Freiburg, Department of Cardiac and Vascular Surgery, Hugstetter Strasse 49, Stuehlinger, Freiburg Im Breisgau
TUM Klinikum Deutsches Herzzentrum
TUM University Hospital German Heart Center, Department of Cardiovascular Surgery, Lazarettstrasse 36, Neuhausen-Nymphenburg, Munich
Universitaetsklinikum Wuerzburg AöR
Clinic and Polyclinic for Thoracic, Cardiac, and Thoracic Vascular Surgery, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg

Sweden

2 sites · Ongoing, recruiting
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Sahlgrenska University Hospital, Department of Cardiothoracic Surgery, Bla Straket 5, 413 46, Goteborg
Region Skane Skanes Universitetssjukhus
Skåne University Hospital Lund, Department of Cardiothoracic Surgery, Entregatan 7, 222 42, Lund

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2024-09-29 2024-10-11
Germany 2024-09-25 2025-02-27
Sweden 2024-09-26 2025-05-14

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Recruitment arrangements (for publication) K1_Recruitment arrangements_DE_Due NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_DE_E NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_DE_F NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_DE_G NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_DE_J NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_DE_M NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_DE_S NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_DE_W NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_Germany_redacted 6.0
Subject information and informed consent form (for publication) L1_SIS and ICF adults_redacted 3.1

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-03 Austria Acceptable
2024-09-23
 2024-09-25
2 SUBSTANTIAL MODIFICATION SM-1 2024-10-11 Acceptable 2024-10-23
3 SUBSTANTIAL MODIFICATION SM-2 2025-11-07 Austria Acceptable 2026-01-19
4 SUBSTANTIAL MODIFICATION SM-3 2025-11-12 Acceptable 2025-11-27

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