Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: no loading with Ticagrelor; Drug: loading with Ticagrelor

• Registration Number: NCT01795820
• Lead Sponsor: University Magna Graecia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-18
• Last Update Submitted: 2013-02-18
• Study First Posted: 2013-02-21
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (no loading)	no loading with Ticagrelor	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.
Group 2 (loading)	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.

Primary Outcome Measures

Name	Time	Method
Platelet aggregation	2 hours	Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA).

Secondary Outcome Measures

Name	Time	Method
30-days clinical events	30 days	major adverse cardiac events (MACE) and bleedings will be evaluated per telephone call at 30 days

Trial Locations

Locations (1)

Magna Graecia University; 🇮🇹 Catanzaro, Calabria, Italy