Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor (SHIFT-OVER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ciro Indolfi, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01795820
First received: February 4, 2013
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Drug: loading with Ticagrelor
Drug: no loading with Ticagrelor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Platelet Aggregation During Pharmacological Shift From Clopidogrel to Ticagrelor in Patients With Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Platelet aggregation [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA).


Secondary Outcome Measures:
  • 30-days clinical events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    major adverse cardiac events (MACE) and bleedings will be evaluated per telephone call at 30 days


Enrollment: 50
Study Start Date: November 2012
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795820

Locations
Italy
Magna Graecia University
Catanzaro, Calabria, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Ciro Indolfi, MD Magna Graecia University
  More Information

Additional Information:
No publications provided by University Magna Graecia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ciro Indolfi, Head of Department (Dipartimento di Scienze Mediche e Chirurgiche), University Magna Graecia
ClinicalTrials.gov Identifier: NCT01795820     History of Changes
Other Study ID Numbers: SHIFT-OVER
Study First Received: February 4, 2013
Last Updated: February 18, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
ticagrelor
clopidogrel
platelet aggregation

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014