Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor

Acute Coronary Syndrome Clinical Trial

— SHIFT-OVER  

Official title:

Platelet Aggregation During Pharmacological Shift From Clopidogrel to Ticagrelor in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795820
• Other study ID #: SHIFT-OVER
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: February 18, 2013
• Start date: November 2012

Study information

• Verified date: February 2013
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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
• no 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.

Locations

Country	Name	City	State
Italy	Magna Graecia University	Catanzaro	Calabria

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet aggregation	Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA).	2 hours	No
Secondary	30-days clinical events	major adverse cardiac events (MACE) and bleedings will be evaluated per telephone call at 30 days	30 days	Yes

External Links

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