Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor (SHIFT-OVER)

University Magna Graecia

Status: Completed

Conditions: Acute Coronary Syndrome

Treatments: Drug: no loading with Ticagrelor; Drug: loading with Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT01795820

SHIFT-OVER

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Group 1 (no loading)

Other group

Description:

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.

Treatment:

Drug: no loading with Ticagrelor

Group 2 (loading)

Other group

Description:

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.

Treatment:

Drug: loading with Ticagrelor