Antiplatelet therapy in patients who undergo coronary artery stenting due to coronary artery disease (CAD) or acute coronary syndrome (ACS). The present study will examine whether ticagrelor, as monotherapy is safe after coronary stenting due to stable CAD and ACS. MedDRA version: 22.1 Level: LLT Classification code 10048560 Term: Coronary artery disease aggravated System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10071111 Term: Non ST segment elevation acute
Conditions
Interventions
Trade Name: Ticagrelor
Product Name: Brilique
Pharmaceutical Form: Tablet
INN or Proposed INN: Ticagrelor
CAS Number: 274693-27-5
Current Sponsor code: AZD6140
Other descriptive name: TICAGRELOR
Conce
Sponsors
Sahlgrenska University Hospital Gothenburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women at least 18 years old. 2. Pre- or intra-procedure treatment with ticagrelor. 3. Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Planned PCI or any planned surgical intervention within the next 6 months. 2. Any indication for chronic anticoagulant therapy 3. Positive COVID-19 antigen or PCR test regardless of symtoms 4. History of definite stent thrombosis 5. Left main coronary artery stenting. 6. Stent thrombosis/restenosis as a culprit lesion. 7. Visible thrombus on angiography after PCI 8. Usage of glycoprotein IIb/IIIa inhibitors 9. Any bifurcation lesion with stenting of both branches. 10. Any treated lesion within an arterial or venous graft. 11. Any additional lesion(s) that need(s) a staged revascularization. 12. Known ejection fraction < 30%. 13. Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2). 14. Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months. 15. Participation in any investigational study that has not yet reached its primary endpoint, and for which monotherapy with ticagrelor may affect the primary outcome (as per the judgement of the investigator). 16. Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir) 17. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception. 18. Expected inability (by the investigator) to comply with the protocol 19. Subjects incapable to giving consent personally
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction.;Secondary Objective: Not applicable;Primary end point(s): The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.;Timepoint(s) of evaluation of this end point: Within 3 months study start i.e. after the Percutaneous Coronary Intervention (PCI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to the following outcomes at 3- and 12 months (unless specified): - Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event) - Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event) - Any spontaneous myocardial infarction (time-to-event) - All-cause mortality (time-to-event) - The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis within 12 months. - Platelet reactivity as assessed by the ADP-test (multiplate), at 24 hours and 3 months. ;Timepoint(s) of evaluation of this end point: At 3- and 12 months (unless specified) | — |
Countries
Sweden
Contacts
Public ContactDepartment of Cardiology
Sahlgrenska University Hospital Gothenburg
Outcome results
None listed