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| Name | Class |
|---|---|
| Gothia Forum - Center for Clinical Trial | OTHER |
| Göteborg University | OTHER |
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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.
The trial is a 1:1 randomized, interventional, multi-national, multi-center, safety/efficacy, parallel assignment, open-label treatment study and will use the RRCT methodology. A RRCT study utilizes existing health care registry platforms to conduct a pragmatic prospective randomized trial.
After the CABG, eligible patients that have consented to the study, will be randomized to either treatment arms. In the intervention arm, patients will be treated with ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months and patients in the control arm will get ASA only (75-160 mg daily according to local guidelines) during the same time period.
The patients will be followed by telephone interviews at 30 days and 365 days after inclusion. After the treatment period patients will be followed during an observation period by collection of outcome data from registries or medical records, 24, 36, 60 and 120 months after inclusion of the patient. No other data but the registry data or data from medical records will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual antiplatelet therapy | Experimental | Ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months |
|
| Acetylsalicylic acid | Active Comparator | ASA 75-160 mg daily for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to all cause death | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences all cause death within 12 months after randomization | within 12 months |
| Time to all cause death, myocardial infarction or stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Jeppssson, MD,PhD,Prof. | Dep. of Cardiothoracic Surgery , Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Aarhus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40888737 | Derived | 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. | |
| 36681173 |
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Parallel treatment arms.
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| 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 |
|
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 a composite endpoint of all cause death, myocardial infarction or stroke after isolated CABG in ACS patients. |
| within 12 months |
| Time to cardiovascular death | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences cardiovascular death within 12 months after randomization | within 12 months |
| Time to first myocardial infarction | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences myocardial infarction within 12 months after randomization | within 12 months |
| Time to first stroke | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of stroke within 12 months after randomization | within 12 months |
| Time to new revascularization | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new revascularization within 12 months after randomization | within 12 months |
| Time to coronary angiography | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of coronary angiography within 12 months after randomization | within 12 months |
| Time to hospitalization for heart failure | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of heart failure within 12 months after randomization | within 12 months |
| Time to cardiovascular hospitalization | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of cardiovascular hospitalization within 12 months after randomization | within 12 months |
| Time to sudden death or aborted cardiac arrest | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of sudden death or aborted cardiac arrest within 12 months after randomization | within 12 months |
| Time to new-onset atrial fibrillation | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new-onset atrial fibrillation within 12 months after randomization | within 12 months |
| Time to major bleeding defined as bleeding requiring hospitalization | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of major bleeding within 12 months after randomization | within 12 months |
| Time to minor bleeding | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of minor bleeding within 12 months after randomization | within 12 months |
| Time to any bleeding | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of any bleeding within 12 months after randomization | within 12 months |
| Time to dyspnea | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of dyspnea within 12 months after randomization | within 12 months |
| Time to dyspnea causing drug interruption | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of dyspnea causing drug interruption within 12 months after randomization | within 12 months |
| Time to new onset renal failure | To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new onset renal failure within 12 months after randomization | within 12 months |
| 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 long-term 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. | 2, 3, 5 and 10 years after the patient has been included in the study |
| Aarhus |
| Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Odense University Hospital | Odense | Denmark |
| Helsinki University Hospital | Helsinki | Finland |
| Kuopio University Hospital | Kuopio | Finland |
| Oulu University Hospital | Oulu | Finland |
| Tampere University Hospital | Tampere | Finland |
| Turku University Hospital | Turku | Finland |
| Landspítali University Hospital | Reykjavik | Iceland |
| St. Olavs hospital, University Hospital | Bergen | Norway |
| Oslo University Hospital | Oslo | Norway |
| University Hospital of North Norway | Tromsø | Norway |
| Haukeland University Hospital | Trondheim | Norway |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| Blekinge Hospital | Karlskrona | Sweden |
| Linköping University Hospital | Linköping | Sweden |
| Skåne University Hospital | Lund | Sweden |
| Örebro University Hospital | Örebro | Sweden |
| Karolinska University Hospital | Stockholm | Sweden |
| University Hospital of Umeå | Umeå | Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| 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. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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