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

Acute Coronary Syndrome Clinical Trial

— TACSI  

Official title:

Dual Antiplatelet Therapy With Ticagrelor and Acetylsalicylic Acid (ASA) vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patient With Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03560310
• Other study ID #: EudraCT 2017-001499-43
• Status: Recruiting
• Phase: Phase 4
• Start date: June 29, 2018
• Est. completion date: June 2031

Study information

• Verified date: October 2023
• Source: Vastra Gotaland Region
• Contact: Anders Jeppsson, MD,PhD,Prof
• Phone: +46 (0)736 601787
• Email: anders.jeppsson[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: June 2031
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent

2. Age =18 years

3. 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:

1. Previously enrolled in this study (i.e. patient now at repeat encounter)

2. Concomitant surgical procedure other than CABG

3. Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux)

4. Discharge from the operating hospital to an ICU at another hospital

5. Pregnancy or lactation

6. Known intolerance or contraindication to ticagrelor or ASA

7. Any disorder that may interfere with drug absorption

8. Any condition other than coronary artery disease with a life expectancy <12 months

9. Known chronic liver disease, renal disease requiring dialysis or bleeding disorder

10. Atrioventricular block II and III in patients without pacemaker

11. Any other indication for dual antiplatelet therapy, i.e. recent stent implantation

12. Debilitating stroke within 90 days before inclusion

13. Previous intracranial bleeding

14. Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus)

15. Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir or atazanavir)

16. Any condition that in the opinion of the investigator may interfere with adherence to trial protocol

17. Participation in any other clinical trial evaluating investigational products at the time for enrollment in this study

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Ticagrelor 90mg twice daily and ASA 75-100 mg daily
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
• ASA 75-160 mg daily
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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
Finland	Helsinki University Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Oulu University Hospital	Oulu
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
Iceland	Landspítali University Hospital	Reykjavík
Norway	St. Olavs hospital, University Hospital	Bergen
Norway	Oslo University Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø
Norway	Haukeland University Hospital	Trondheim
Sweden	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

Sponsors (3)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Gothia Forum - Center for Clinical Trial, Uppsala University

Countries where clinical trial is conducted

Denmark,  Finland,  Iceland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to all cause death, myocardial infarction or stroke	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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