Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor

NCT ID: NCT01795820

Last Updated: 2013-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Group 1 (no loading)

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 Type: OTHER

no loading with Ticagrelor

Intervention Type: DRUG

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.

Group 2 (loading)

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.

Group Type: OTHER

loading with Ticagrelor

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Ciro Indolfi

Head of Department (Dipartimento di Scienze Mediche e Chirurgiche)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ciro Indolfi, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University

Locations

Magna Graecia University

Catanzaro, Calabria, Italy

Countries

Italy

References

Caiazzo G, De Rosa S, Torella D, Spaccarotella C, Mongiardo A, Giampa S, Micieli M, Palella E, Gulletta E, Indolfi C. Administration of a loading dose has no additive effect on platelet aggregation during the switch from ongoing clopidogrel treatment to ticagrelor in patients with acute coronary syndrome. Circ Cardiovasc Interv. 2014 Feb;7(1):104-12. doi: 10.1161/CIRCINTERVENTIONS.113.000512. Epub 2014 Jan 21.

Reference Type: DERIVED

PMID: 24449597 (View on PubMed)

Related Links

http://dsmc.unicz.it/

Related Info

Other Identifiers

SHIFT-OVER

Identifier Type: -

Identifier Source: org_study_id