Ticagrelor and ASA vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome

NCT03560310 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: EudraCT 2017-001499-43
• Study Type: interventional
• Target: 2,201
• Locations: 5 countries
• Sites: 22

Brief Summary

The study is a Randomised Registry-based Clinical Trial (RRCT) to assess whether dual antiplatelet therapy with ticagrelor and ASA compared to ASA alone improves outcome after isolated CABG in patients with acute coronary syndrome.

Conditions

Acute Coronary Syndrome

Keywords

Coronary Bypass Grafting; Antiplatelet treatment

Outcome Measures

Primary Outcomes (1)

• Time to major adverse cardiovascular events (MACE)

  To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.

  within12 months

Secondary Outcomes (18)

• Time to all cause death

  within 12 months

• Time to all cause death, myocardial infarction or stroke

  within 12 months

• Time to cardiovascular death

  within 12 months

• Time to first myocardial infarction

  within 12 months

• Time to first stroke

  within 12 months

Study Arms (2)

Dual antiplatelet therapy

EXPERIMENTAL

Ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months

Drug: Ticagrelor 90mg twice daily and ASA 75-100 mg daily

Acetylsalicylic acid

ACTIVE COMPARATOR

ASA 75-160 mg daily for 12 months

Drug: ASA 75-160 mg daily

Interventions

Ticagrelor 90mg twice daily and ASA 75-100 mg daily DRUG

Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome

Dual antiplatelet therapy

ASA 75-160 mg daily DRUG

Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome

Acetylsalicylic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Gothia Forum - Center for Clinical Trial: collaborator
• Göteborg University: collaborator

Study Sites (22)

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Landspítali University Hospital

Reykjavik, Iceland

Location

St. Olavs hospital, University Hospital

Bergen, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

Haukeland University Hospital

Trondheim, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Blekinge Hospital

Karlskrona, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Skåne University Hospital

Lund, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

University Hospital of Umeå

Umeå, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (2)

• Jeppsson A, James S, Moller CH, Malm CJ, Dalen M, Vanky F, Modrau IS, Andersen K, Anttila V, Atroshchenko GV, Barbu M, Dreifaldt M, El-Akkawi AI, Friberg O, Gudbjartsson T, Gunn J, Haaverstad R, Halonen J, Hansson EC, Holm J, Husso A, Juvonen T, Jakobsen O, Jideus L, Johannesson E, Jonsson Holmdahl A, Jonsson K, Kolseth SM, Krasniqi L, Makela T, Mennander A, Mohagen Krogstad LE, Rafiq S, Raivio P, Riber L, Tahir A, Thorsen C, Tonnessen T, Wahba A, Zindovic I, Pivodic A, Nielsen SJ, Erlinge D, Alfredsson J, Sartipy U; TACSI Trial Group.; TACSI Trial Group. Ticagrelor and Aspirin or Aspirin Alone after Coronary Surgery for Acute Coronary Syndrome. N Engl J Med. 2025 Dec 11;393(23):2313-2323. doi: 10.1056/NEJMoa2508026. Epub 2025 Sep 1.

  PMID: 40888737 DERIVED

• Malm CJ, Alfredsson J, Erlinge D, Gudbjartsson T, Gunn J, James S, Moller CH, Nielsen SJ, Sartipy U, Tonnessen T, Jeppsson A. Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial): Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial. Am Heart J. 2023 May;259:1-8. doi: 10.1016/j.ahj.2023.01.011. Epub 2023 Jan 18.

  PMID: 36681173 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Anders Jeppssson, MD,PhD,Prof.

  Dep. of Cardiothoracic Surgery , Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Parallel treatment arms.

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 18, 2018
• Study Start: June 29, 2018
• Primary Completion: March 13, 2025
• Study Completion (Estimated): February 15, 2035
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4); IC (1); DK (4); FI (5); SE (8)