Clinical trial NCT03560310: Ticagrelor and ASA vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Coronary Bypass Grafting
Antiplatelet treatment
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Gothia Forum - Center for Clinical Trial
name: Göteborg University
First posted: 2018-06-18
Enrollment: 2203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel treatment arms.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to major adverse cardiovascular events (MACE)
timeFrame: within12 months
Secondary outcomes:
measure: Time to all cause death
timeFrame: within 12 months
measure: Time to all cause death, myocardial infarction or stroke
timeFrame: within 12 months
measure: Time to cardiovascular death
timeFrame: within 12 months
measure: Time to first myocardial infarction
timeFrame: within 12 months
measure: Time to first stroke
timeFrame: within 12 months
measure: Time to new revascularization
timeFrame: within 12 months
measure: Time to coronary angiography
timeFrame: within 12 months
measure: Time to hospitalization for heart failure
timeFrame: within 12 months
measure: Time to cardiovascular hospitalization
timeFrame: within 12 months
measure: Time to sudden death or aborted cardiac arrest
timeFrame: within 12 months
measure: Time to new-onset atrial fibrillation
timeFrame: within 12 months
measure: Time to major bleeding defined as bleeding requiring hospitalization
timeFrame: within 12 months
measure: Time to minor bleeding
timeFrame: within 12 months
measure: Time to any bleeding
timeFrame: within 12 months
measure: Time to dyspnea
timeFrame: within 12 months
measure: Time to dyspnea causing drug interruption
timeFrame: within 12 months
measure: Time to new onset renal failure
timeFrame: within 12 months
measure: Time to major adverse cardiovascular events (MACE)
timeFrame: 2, 3, 5 and 10 years after the patient has been included in the study
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Reykjavík
country: Iceland
facility: Landspítali University Hospital
city: Bergen
country: Norway
facility: St. Olavs hospital, University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: Haukeland University Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Karlskrona
country: Sweden
facility: Blekinge Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umeå
country: Sweden
facility: University Hospital of Umeå
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Dep. of Cardiothoracic Surgery , Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden
name: Anders Jeppssson, MD,PhD,Prof.
role: PRINCIPAL_INVESTIGATOR
References: