Acute Coronary Syndrome
Conditions
Keywords
ticagrelor, clopidogrel, platelet aggregation
Brief summary
Antiplatelet therapy with ticagrelor is currently indicated for treatment of patients presenting with acute coronary syndrome. Such therapy is started with the administration of a loading dose in patients which are not yet under treatment with P2Y12 inhibitors (antiplatelet agents). However it is unknown whether a loading dose is needed to maintain a satisfactory inhibition of platelet aggregation in patients who are already treated with a previous generation P2Y12 inhibitor (clopidogrel) during the passage to the newer compound ticagrelor. For this reason aim of the present study is to evaluate the levels of platelet aggregation during the pharmacological shift from clopidogrel to ticagrelor performed with or without a loading starting dose of the newer drug.
Interventions
DRUGloading with Ticagrelor
Patients allocated in the two study arms will receive the same anti platelet treatment, except for the administration of the loading dose, which will be only administered to patients allocated in Group 2
DRUGno loading with Ticagrelor
Patients allocated in the two study arms will receive the same anti platelet treatment, except for the administration of the loading dose, which will be only administered to patients allocated in Group 2. In other words, patients randomized to this group (group 1) will not receive a loading dose of ticagrelor during the passage from clopidogrel to ticagrelor.
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Acute Coronary Syndrome * Current dual anti platelet treatment with ASA and Clopidogrel
Exclusion criteria
* No coronary revascularization within the previous six months * Ongoing therapy with ticagrelor, prasugrel or ticlopidine before enrollment * No treatment with glycoprotein IIb/IIIa inhibitors within the previous 6 days * Patients which are known to be no responders to Clopidogrel * Known neoplastic or autoimmune disease * Liver cirrhosis * Severe pulmonary disease * Known disorder of Haemostasis * Previous Stroke * Ongoing pregnancy * Therapy with any inhibitor of P450 Cytochrome until 15 days before enrollment * Low platelet count or Hb\<10 g/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet aggregation | 2 hours | Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-days clinical events | 30 days | major adverse cardiac events (MACE) and bleedings will be evaluated per telephone call at 30 days |
Countries
Italy
Outcome results
None listed