An interventional study of loading with Ticagrelor and no loading with Ticagrelor in Acute Coronary Syndrome, sponsored by University Magna Graecia. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-02-21.
Sponsored by University Magna Graecia · Not applicable and Interventional
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 50 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Patients allocated to this group will not receive a loading dose of ticagrelor. In other words, clopidogrel 75 mg/die will be administered until the day before the pharmacological shift (study start), while ticagrelor 90 mg bis in die will be administered from the day of the pharmacological shift on.
Drug: no loading with Ticagrelor
Patients allocated to this group will receive a loading dose of ticagrelor. In other words, clopidogrel 75 mg/die will be administered until the day before the pharmacological shift (study start). On the very day of the pharmacological shift, patients allocated in Group 2 will receive Ticagrelor 180 mg (loading dose) on the morning and Ticagrelor 90 mg on the evening, while ticagrelor 90 mg bis in die will be administered from the day after the pharmacological shift on.
Drug: 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
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.
Platelet aggregation
Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA).
Time frame: 2 hours
30-days clinical events
major adverse cardiac events (MACE) and bleedings will be evaluated per telephone call at 30 days
Time frame: 30 days
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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University Magna Graecia