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

Vastra Gotaland Region

Status and phase: Active, not recruiting; Phase 4

Conditions: Acute Coronary Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03560310

EudraCT 2017-001499-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,201 participants in 2 patient groups

Dual antiplatelet therapy

Experimental group

Description:

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

Treatment:

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

Acetylsalicylic acid

Active Comparator group

Description:

ASA 75-160 mg daily for 12 months

Treatment:

Drug: ASA 75-160 mg daily