Clinical trial • Phase IV • Cardiology

acetylsalicylic acid for Multi-vessel coronary artery disease with left main stenosis

Phase IV trial of acetylsalicylic acid for Multi-vessel coronary artery disease with left main stenosis.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Multi-vessel coronary artery disease with left main stenosis
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-09-2024
First CTIS Authorization Date
23-10-2024

Trial design

Ticagrelor + acetylsalicylic acid (ASA) versus acetylsalicylic acid (ASA) alone; doses and schedules not specified in the record.-controlled Phase IV trial across 22 sites in Denmark, Finland, Norway and others.

Comparator
Ticagrelor + acetylsalicylic acid (ASA) versus acetylsalicylic acid (ASA) alone; doses and schedules not specified in the record.
Target Sample Size
2200
Trial Duration For Participant
365

Eligibility

Recruits 2200 Vulnerable population not selected; participants must provide "Written informed consent"; minimum age is 18 years so no assent or minor-specific consent described; country-specific subject information and informed consent forms are provided..

Pregnancy Exclusion
Pregnancy or lactation
Vulnerable Population
Vulnerable population not selected; participants must provide "Written informed consent"; minimum age is 18 years so no assent or minor-specific consent described; country-specific subject information and informed consent forms are provided.

Inclusion criteria

  • {"criterion_text":"- Written informed consent\n- Age ≥18 years\n- Has undergone first time isolated CABG due to an episode of acute coronary syndrome (STEMI, NSTEMI, unstable angina) within 6 weeks before surgery"}

Exclusion criteria

  • {"criterion_text":"- Previously enrolled in this study (i.e. patient now at repeat encounter)\n- AV-block II and III in patients without pacemaker\n- Any other indication for dual antiplatelet therapy, i.e. recent stent implantation\n- Debilitating stroke within 90 days before inclusion\n- Previous intracranial bleeding\n- Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus)\n- Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodon, ritonavir or atazanavir)\n- Any condition that in the opinion of the investigator may interfere with adherence to trial protocol\n- Participation in any other clinical trial evaluating investigational products at the time for enrollment in this study\n- Concomitant surgical procedure other than CABG\n- Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux)\n- Discharge from the operating hospital to an ICU at another hospital\n- Pregnancy or lactation\n- Known intolerance or contraindication to ticagrelor or ASA\n- Any disorder that may interfere with drug absorption\n- Any condition other than coronary artery disease with a life expectancy <12 months\n- Known chronic liver disease, renal disease requiring dialysis or bleeding disorder"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- A composite endpoint of the time to all cause death, or myocardial infarction, or stroke, or new coronary revascularization within 12 months","definition_or_measurement_approach":"Time-to-event composite measured as time to first occurrence of all-cause death, myocardial infarction, stroke, or new coronary revascularization within 12 months."}

Secondary endpoints

  • {"endpoint_text":"- Time to all cause death\n- Time to all cause death, myocardial infarction or stroke\n- Time to cardiovascular death\n- Time to first myocardial infarction\n- Time to first stroke\n- Time to new revascularization\n- Time to coronary angiography\n- Time to hospitalization for heart failure\n- Time to cardiovascular hospitalization\n- Time to sudden death or aborted cardiac arrest\n- Time to new-onset AF","definition_or_measurement_approach":"All secondary endpoints are time-to-event measures (time from randomisation/enrolment to the specified event)."}

Recruitment

Planned Sample Size
2200
Recruitment Window Months
189
Consent Approach
Written informed consent is required from participants. Subject information and informed consent form documents (L1 Subject Info and ICF) are provided for Denmark, Finland (including a Swedish text version), Norway (version 2.3 noted), Iceland and Sweden. Minimum age for consent is 18 years; no assent process for minors is described.

Geography

Total Number Of Sites
22
Total Number Of Participants
2200

Denmark

Latest Decision Or Authorization Date
23-10-2024
Number Of Sites
4
Number Of Participants
400

Sites

Site Name
Odense University Hospital
Department Name
Department T of Cardio, Vascular and Thoracic surgery, J B Winsloews Vej 4, 5000 Odense C
Contact Person Name
Lars Riber
Contact Person Email
lars.riber@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department of Thoracic Surgery, Section 2152, Inge Lehmanns Vej 7, 2100 Copenhagen Ø
Contact Person Name
Christian Möller
Site Name
Aarhus Universitetshospital
Department Name
Department of Cardiothoracic and Vascular Surgery, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N
Contact Person Name
Ivy Susanne Modrau
Contact Person Email
ivy.modrau@skejby.rm.dk
Site Name
Aalborg University Hospital
Department Name
Clinic for Anaesthesiology, Child Diseases, Circulation and Women, Hobrovej 18-22, 9000 Aalborg
Contact Person Name
Gennady V. Atroshchenko
Contact Person Email
g.atroshchenko@rn.dk

Finland

Latest Decision Or Authorization Date
23-10-2024
Number Of Sites
5
Number Of Participants
200

Sites

Site Name
TAYS Sydaenkeskus Oy
Department Name
Department Heart Center, TAYS Sydänkeskus Oy, P. O. Box 2000, 33521 Tampere
Contact Person Name
Ari Mennander
Contact Person Email
ari.mennander@sydansairaala.fi
Site Name
Oulu University Hospital
Department Name
Department Operative Care, P.O. box 21 90029, OYS Finland, Kajaanintie 50, 90220 Oulu
Contact Person Name
Tuomas Mäkelä
Contact Person Email
tuomas.makela@ppshp.fi
Site Name
Kuopio University Hospital
Department Name
KYS,NorthernSavoHospital,DistrictMunicipalFederation,Dept Heart Center,Puijonlaaksontie2,7021 Kuopio
Contact Person Name
Annastiina Husso
Contact Person Email
annastiina.husso@kuh.fi
Site Name
Turku University Hospital
Department Name
Hospital District of South-West Finland, Heart Center TYKS Kiinanmyllynkatu 4-8 20520 Turku
Contact Person Name
Jarmo Gunn
Contact Person Email
jarmo.gunn@tyks.fi
Site Name
Meilahti Hospital
Department Name
Helsinki University Hospital, Heart and Lung Center, Haaermaninkatu 4, PL 340, 0029 HUS, Helsinki
Contact Person Name
Peter Raivio
Contact Person Email
peter.raivio@hus.fi

Norway

Latest Decision Or Authorization Date
24-10-2024
Number Of Sites
4
Number Of Participants
400

Sites

Site Name
St. Olavs Hospital HF
Department Name
St. Olavs hospital, Department of Cardiothoracic Surgery, Prinsesse Kristinas gt. 3, 7030 Trondheim
Contact Person Name
Alexander Wahba
Contact Person Email
alexander.wahba@ntnu.no
Site Name
Oslo University Hospital HF
Department Name
Department of Cardiothoracic Surgery, Postboks 4950 Nydalen, 0424 Oslo
Contact Person Name
Theis Tönnessen
Contact Person Email
UXTHTO@ous-hf.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Departement of Cardiothoracic and Vascular surgery, Hansine Hansens veg 67, 9019 Tromsø
Contact Person Name
Øyvind Jakobsen
Contact Person Email
Oyvind.Jakobsen@unn.no
Site Name
Helse Bergen HF
Department Name
Haukeland University Hospital, Department of Thoracic Surgery, Jonas Lies vei 65, 5021 Bergen
Contact Person Name
Rune Haaverstad

Iceland

Latest Decision Or Authorization Date
10-12-2024
Number Of Sites
1
Number Of Participants
100

Sites

Site Name
Landspitali
Department Name
TheNationalUniversityHospitalofIceland, Dept of Cardiothoracic Surgery, Hringbraut 101,105 Reykjavik
Contact Person Name
Tomas Gudbjartsson
Contact Person Email
tomasgud@landspitali.is

Sweden

Latest Decision Or Authorization Date
23-10-2024
Number Of Sites
8
Number Of Participants
1100

Sites

Site Name
Region Oestergoetland
Department Name
Department of Cardiothoracic surgery, Heart and Medicine center, 581 85 Linköping, Sweden
Contact Person Name
Farkas Vanky
Contact Person Email
region@regionostergotland.se
Site Name
Karolinska University Hospital
Department Name
Heart & Vascular Theme, 171 76 Stockholm, Sweden
Contact Person Name
Ulrik Sartipy
Contact Person Email
Ulrik.Sartipy@karolinska.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Cardiothoracic Surgery, 221 85 Lund, Sweden
Contact Person Name
Shahab Nozohoor
Contact Person Email
Shahab.Nozohoor@skane.se
Site Name
Region Blekinge
Department Name
Department of Cardiothoracic Surgery, 371 41 Karlskrona, Sweden
Contact Person Name
Carl Thorsén
Contact Person Email
carl.thorsen@regionblekinge.se
Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
Department of Cardiothoracic surgery, Blå stråket 5, 413 45 Gothenburg, Sweden
Contact Person Name
Carl-Johan Malm
Contact Person Email
carl.malm@vgregion.se
Site Name
Uppsala University Hospital
Department Name
Department of Thoracic and Cardiovascular Surgery, 751 85 Uppsala, Sweden
Contact Person Name
Lena Jidéus
Contact Person Email
lena.jideus@akademiska.se
Site Name
Region Oerebro Laen
Department Name
Department of Cardiothoracic and vascular surgery, Södra Grevrosengatan, 701 85 Örebro, Sweden
Contact Person Name
Mats Dreifaldt
Site Name
Region Vaesterbotten
Department Name
Department of Public Health and clinical Medicine, Heart Center, 901 85 Umeå, Sweden
Contact Person Name
Anna L Jonsson

Sponsor

Primary sponsor

Full Name
Vaestra Goetalandsregionen
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"Sponsor duties (code: 1)","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
ACETYLSALICYLIC ACID
Active Substance
acetylsalicylic acid
Modality
Small molecule
Routes Of Administration
GASTROENTERAL USE
Route
Oral
Maximum Dose
160 mg (maxDailyDoseAmount)
Investigational Product Name
TICAGRELOR
Active Substance
ticagrelor
Modality
Small molecule
Routes Of Administration
GASTROENTERAL USE
Route
Oral
Maximum Dose
180 mg (maxDailyDoseAmount)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.