Platelet ReactivityPhase 4NCT01463163
Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
A Phase 4 study testing Prasugrel and Ticagrelor in people with Platelet Reactivity, run by University of Patras at 1 site in Greece.
Trial summary
This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic study with a parallel design. Patients with ST elevation myocardial infarction, undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1 ratio to the following treatment groups… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Platelet Reactivity
- What is being tested?
- Prasugrel and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2011to Apr 2012
- Phase
- Phase 4
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Patients with STEMI undergoing primary PCI with stenting
- Informed consent obtained in writing
Who cannot join
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable until the Day 5
- Prior PCI performed within 30 days prior to randomization
- Cardiogenic shock
- Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (arteriovenous shunt, retroperitoneal bleeding), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
Show all 25Show fewer
- Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 5 days after randomization
- Requirement for oral anticoagulant prior to the Day 5 visit
- Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
- Known hypersensitivity to prasugrel or ticagrelor
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
- Other bleeding diathesis, or considered by investigator to be at high risk for bleeding.
- Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thombocytopenia (<100.000 / μL) at randomization
- Anaemia (Hct <30%) at randomization
- Polycytaemia (Hct > 52%) at randomization
- Periprocedural IIb/IIIa inhibitors administration
- Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
- Recent (< 6 weeks) major surgery or trauma, including GABG.
- Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
- Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine).
- Increased risk of bradycardiac events.
- Dialysis required.
- Severe uncontrolled chronic obstructive pulmonary disease
- Known severe hepatic impairement
Trial locations and contacts
1 site in 1 country.
Greece1 site
Cardiology Department Patras University Hospital
Rio, Achaia, 26500
About this study
This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic study with a parallel design. Patients with ST elevation myocardial infarction, undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after randomization).
Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24 hours after randomization, and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.
- Conditions
- Platelet Reactivity
- Being tested
- Prasugrel, Ticagrelor
- Keywords
- Platelet reactivity, Ticagrelor, Prasugrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours
TicagrelorDrug
Ticagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Active comparator | Prasugrel 60mg LD followed by 10mg MD starting post 24 hours Receives: Drug: Prasugrel |
| Ticagrelor | Experimental | Ticagrelor 180mg LD followed by 90mg x2 MD starting post 12±6 hours Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization
Measured: 1hour
Secondary outcomes (9)
Platelet reactivity
Platelet Reactivity assessed by Multiplate analyzer assay 1 hour post randomization
Measured: 1 hour
Platelet reactivity
Platelet reactivity assessed by the VerifyNow assay 2 hours post randomization
Measured: 2 hours
Platelet reactivity
Platelet Reactivity assessed by Multiplate analyzer 2 hours post randomization
Measured: 2 hours
Platelet reactivity
Platelet Reactivity assessed by VerifyNow P2Y12 assay 6 hours post randomization
Measured: 6 hours
Platelet reactivity
Platelet Reactivity assessed by Multiplate analyzer 6 hours post randomization
Measured: 6 hours
Platelet reactivity
Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization
Measured: 24 hours
Platelet reactivity
Platelet Reactivity assessed by Multiplate analyzer 24 hours post randomization
Measured: 24 hours
Platelet reactivity
Platelet Reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization
Measured: 5 days
Platelet reactivity
Platelet Reactivity assessed by Multiplate analyzer 5 days post randomization
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionApr 2012
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 Platelet ReactivityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Alexopoulos, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463163
- Sponsor's protocol ID
- PATRASCARDIOLOGY-8
- Status last verified
- Apr 2012
- First submitted
- 27 Oct 2011
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexopoulos D, Xanthopoulou I, Gkizas V, Kassimis G, Theodoropoulos KC, Makris G, Koutsogiannis N, Damelou A, Tsigkas G, Davlouros P, Hahalis G. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2012 Dec;5(6):797-804. doi: 10.1161/CIRCINTERVENTIONS.112.972323. Epub 2012 Nov 20.
PubMed 23169985
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT01463163
- Acronym / sponsor ID
- PATRASCARDIOLOGY-8
- Conditions
- Platelet Reactivity
- Keywords
- Platelet reactivity, Ticagrelor, Prasugrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Nov 2011 (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.
This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic study with a parallel design. Patients with ST elevation myocardial infarction, undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after randomization).
Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24 hours after randomization, and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | Active comparator | Drug: PrasugrelPrasugrel 60mg LD followed by 10mg MD starting post 24 hours |
| Ticagrelor | Experimental | Drug: TicagrelorTicagrelor 180mg LD followed by 90mg x2 MD starting post 12±6 hours |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old
- Patients with STEMI undergoing primary PCI with stenting
- Informed consent obtained in writing
Key exclusion criteria (25 listed)
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable until the Day 5
- Prior PCI performed within 30 days prior to randomization
- Cardiogenic shock
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 |
|---|---|---|
| PrasugrelPrasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours | Drug | Prasugrel |
| TicagrelorTicagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours | Drug | Ticagrelor |
Primary outcome
Platelet reactivity
Time frame: 1hour
Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization
9 secondary outcomes
Platelet reactivity
Time frame: 1 hour
Platelet reactivity
Time frame: 2 hours
Platelet reactivity
Time frame: 2 hours
Platelet reactivity
Time frame: 6 hours
Platelet reactivity
Time frame: 6 hours
Platelet reactivity
Time frame: 24 hours
Platelet reactivity
Time frame: 24 hours
Platelet reactivity
Time frame: 5 days
Platelet reactivity
Time frame: 5 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 10 Apr 2012.
- Derived from this study: PubMed 23169985Alexopoulos D, Xanthopoulou I, Gkizas V, Kassimis G, Theodoropoulos KC, Makris G, Koutsogiannis N, Damelou A, Tsigkas G, Davlouros P, Hahalis G. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2012 Dec;5(6):797-804. doi: 10.1161/CIRCINTERVENTIONS.112.972323. Epub 2012 Nov 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasugrel and Ticagrelor in people with Platelet Reactivity, run by University of Patras at 1 site in Greece.
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 3 inclusion and 25 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 10 Apr 2012. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 reactivity (time frame: 1hour). 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 NCT01463163, 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 10 Apr 2012.