Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor

NCT01795820 | Completed

• 1 other identifier: SHIFT-OVER
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

ticagrelor; clopidogrel; platelet aggregation

Outcome Measures

Primary Outcomes (1)

• Platelet aggregation

  Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA).

  2 hours

Secondary Outcomes (1)

• 30-days clinical events

  30 days

Study Arms (2)

Group 1 (no loading)

OTHER

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

Group 2 (loading)

OTHER

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

Interventions

loading with Ticagrelor 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

Group 2 (loading)

no loading with Ticagrelor 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 1 (no loading)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Coronary Syndrome
• Current dual anti platelet treatment with ASA and Clopidogrel

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Magna Graecia University

Catanzaro, Calabria, 88100, Italy

Location

Related Publications (1)

• 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.

  PMID: 24449597 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Ciro Indolfi, MD

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department (Dipartimento di Scienze Mediche e Chirurgiche)

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 21, 2013
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

IT (1)