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Completed

NCT Number: NCT01795820

Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magna Graecia University

Catanzaro, Calabria, 88100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Platelet aggregation

    Time frame: 2 hours

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

Secondary outcomes

  1. 30-days clinical events

    Time frame: 30 days

    major adverse cardiac events (MACE) and bleedings will be evaluated per telephone call at 30 days

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Acronym: SHIFT-OVER

Important dates

Study start
2012
Primary completion
2013
First posted
Feb 21, 2013
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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