Acute Coronary SyndromeSHIFT-OVERNCT01795820
Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor
A study testing loading with Ticagrelor and no loading with Ticagrelor in people with Acute Coronary Syndrome, run by University Magna Graecia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- loading with Ticagrelor and no loading with Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Coronary Syndrome
- Current dual anti platelet treatment with ASA and Clopidogrel
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- loading with Ticagrelor, no loading with Ticagrelor
- Keywords
- ticagrelor, clopidogrel, platelet aggregation
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loading with TicagrelorDrug
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 TicagrelorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: loading with Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation
Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA).
Measured: 2 hours
Secondary outcomes (1)
30-days clinical events
major adverse cardiac events (MACE) and bleedings will be evaluated per telephone call at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Indolfi, University Magna Graecia
- Investigators
- Ciro Indolfi, MD, Principal investigator, Magna Graecia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795820
- Sponsor's protocol ID
- SHIFT-OVER
- Acronym
- SHIFT-OVER
- Status last verified
- Feb 2013
- First submitted
- 4 Feb 2013
- Last updated
- 21 Feb 2013
- Results posted
- No
Publications
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.
PubMed 24449597
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Aggregation During Pharmacological Shift From Clopidogrel to Ticagrelor in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01795820
- Acronym / sponsor ID
- SHIFT-OVER / SHIFT-OVER
- Conditions
- Acute Coronary Syndrome
- Keywords
- ticagrelor, clopidogrel, platelet aggregation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (no loading) | Other | Drug: no loading with TicagrelorPatients 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. |
| Group 2 (loading) | Other | Drug: loading with TicagrelorPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute Coronary Syndrome
- Current dual anti platelet treatment with ASA and Clopidogrel
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loading with TicagrelorPatients 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 | Group 2 (loading) |
| no loading with TicagrelorPatients 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. | Drug | Group 1 (no loading) |
Primary outcome
Platelet aggregation
Time frame: 2 hours
Platelet aggregation is measured by means of Multiple Electrode Aggregometry (MEA) and Light Transmission Aggregometry (LTA).
1 secondary outcome
30-days clinical events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
- Derived from this study: PubMed 24449597Caiazzo 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciro Indolfi, MD principal investigator
Magna Graecia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing loading with Ticagrelor and no loading with Ticagrelor in people with Acute Coronary Syndrome, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet aggregation (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.