Effects of dual anti-platelet therapy on platelet aggregation in patients who have received percutaneous coronary intervention (PCI) with coronary stenting. Circulatory System
Conditions
Interventions
This prospective, single centre, observational study will recruit “all comer” patients enrolled in the GLOBAL LEADERS study who are attending the Clinical Research Facility in the Beardmore Centre for
Group 2, previously randomised to switch from ticagrelor and aspirin to aspirin monotherapy at 12 months (standard treatment group). Baseline measurements of platelet aggregation, high sensitivity CRP
Sponsors
NHS National Waiting Times Centre Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients eligible for this study are those already enrolled in the GLOBAL LEADERS study under the care of the Golden Jubilee National Hospital (UK) during the allocated study period. 2. The inclusion criteria for the GLOBAL LEADERS trial will apply to this study including: 2.1. Age =18 years 2.2. 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 2.3. Able to provide informed consent
Exclusion criteria
Exclusion criteria: The exclusion criteria for the GLOBAL LEADERS study will also apply to this study including: 1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus 2. 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. 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. History of intracranial haemorrhagic stroke or intra-cranial aneurysm 8. Stroke (any type) within the last 30 days 9. Pregnancy at time of randomisation 10. Breastfeeding at time of randomisation 11. Currently participating in another trial and not yet at its primary endpoint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet aggregation in response to collagen measured using impedance aggregometry. Multiplate©. Measured on DAPT treatment and 2, 7 and 14 days after cessation. Once DAPT has been stopped patients will continue with aspirin or ticagrelor monotherapy according to their randomisation status in GLOBAL LEADERS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Platelet aggregation in response to arachidonic acid, ADP or thrombin receptor activator peptide 6 (TRAP-6). Measured using impedance aggregometry (Multiplate© ). 2. High sensitivity C-Reactive Protein (hsCRP) (using particle enhanced immunonephelometry with Immage analyzer Beckman Coulter) 3. Serum and plasma thromboxane measured using ELISA (R&D Systems Europe; cat. no. KGE011). All secondary endpoints will be measured on DAPT treatment and 2, 7 and 14 days after cessation. | — |
Countries
United Kingdom
Contacts
Public ContactMichael Campbell
Outcome results
None listed