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

February 4, 2013
February 18, 2013
November 2012
January 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01795820 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor
Platelet Aggregation During Pharmacological Shift From Clopidogrel to Ticagrelor in Patients With Acute Coronary Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Acute Coronary Syndrome
  • 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
  • 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 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.
    Intervention: Drug: no loading with 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.
    Intervention: Drug: loading with Ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Not Provided
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01795820
SHIFT-OVER
Not Provided
Ciro Indolfi, University Magna Graecia
University Magna Graecia
Not Provided
Principal Investigator: Ciro Indolfi, MD Magna Graecia University
University Magna Graecia
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP