- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01795820
Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor (SHIFT-OVER)
February 18, 2013 updated by: Ciro Indolfi, University Magna Graecia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Calabria
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Catanzaro, Calabria, Italy, 88100
- Magna Graecia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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. |
Other: 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet aggregation
Time Frame: 2 hours
|
Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA).
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-days clinical events
Time Frame: 30 days
|
major adverse cardiac events (MACE) and bleedings will be evaluated per telephone call at 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ciro Indolfi, MD, Magna Graecia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
February 4, 2013
First Submitted That Met QC Criteria
February 18, 2013
First Posted (Estimate)
February 21, 2013
Study Record Updates
Last Update Posted (Estimate)
February 21, 2013
Last Update Submitted That Met QC Criteria
February 18, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
Other Study ID Numbers
- SHIFT-OVER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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