angina pectoris coronair artery disease
Conditions
Interventions
Experimental treatment strategy
All patients in the treatment group will receive acetylsalicylic acid (ASA) and
ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Reference treat
Sponsors
ECRI / Cardialysis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *Real world, all comer* patients;1. Age *18 years;;2. Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation in a vessel with a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, and vessels, and lesion length).;3. Able to provide informed consent and willing to participate in 2 year follow-up period.
Exclusion criteria
Exclusion criteria: 1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;;2. Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;;3. Known moderate to severe hepatic impairment (alanine-aminotransferase * 3 x ULN);;4. Planned surgery, including CABG as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;;5. Need for chronic oral anti-coagulation therapy;;6. Active major bleeding or major surgery within the last 30 days;;7. Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;;8. Known stroke (any type) within the last 30 days;;9. Known pregnancy at time of randomisation;;10. Female who is breastfeeding at the time of randomisation.;11. Currently participating in another trial and not yet at its primary endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The composite of investigator-reported BARC3 or BARC5 bleeding according to BARC definitions up to 2 years post randomisation. | — |
Countries
Netherlands
Outcome results
None listed