Platelet ReactivityPhase 3NCT01835353
High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
A Phase 3 study testing Prasugrel 100mg loading dose and Prasugrel 60mg loading dose in people with Platelet Reactivity, run by University of Patras at 1 site in Greece.
Trial summary
This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin 325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Platelet Reactivity
- What is being tested?
- Prasugrel 100mg loading dose and Prasugrel 60mg loading dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2012to Jul 2013
- Phase
- Phase 3
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST elevation myocardial infarction
- Pain onset <12 hours
- Age >18 and <75 years
- Written informed consent
Who cannot join
- history of stroke/transient ischemic attack
- oral anticoagulation
- hemodynamic instability
- platelet count <100000/μL
- hematocrit <30%
- creatinine clearance <30 ml/min
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- severe hepatic dysfunction
- active bleeding
- weight <60 Kg
- periprocedural IIb/IIIa inhibitor administration
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin 325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.
- Conditions
- Platelet Reactivity
- Being tested
- Prasugrel 100mg loading dose, Prasugrel 60mg loading dose
- Keywords
- prasugrel, ST elevation myocardial infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasugrel 100mg loading doseDrug
Prasugrel 60mg loading doseDrug
Prasugrel 60mg loading dose
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel 100mg loading dose | Experimental | Prasugrel 100mg loading dose Receives: Drug: Prasugrel 100mg loading dose |
| Prasugrel 60mg loading dose | Active comparator | Not described Receives: Drug: Prasugrel 60mg loading dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity in Platelet reactivity units (PRU) at Hour 2
Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization
Measured: 2 hours
Secondary outcomes (7)
Platelet reactivity in platelet reactivity units (PRU)at hour 1
Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization
Measured: 1 hour
Platelet reactivity in platelet reactivity units (PRU)at hour 0.5
Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization
Measured: 0.5 hours
Platelet reactivity in platelet reactivity units (PRU)at hour 4
Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization
Measured: 4 hours
High platelet reactivity rate (208 PRU threshold) at 0.5 hour
High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization
Measured: 0.5 hour
High platelet reactivity rate (208 PRU threshold) at 1 hour
High platelet reactivity rate (208 PRU threshold) 1 hour post randomization
Measured: 1 hour
High platelet reactivity rate (208 PRU threshold) at 2 hour
High platelet reactivity rate (208 PRU threshold) 2 hours post randomization
Measured: 2 hours
High platelet reactivity rate (208 PRU threshold) at 4 hour
High platelet reactivity rate (208 PRU threshold) 4 hours post randomization
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionJul 2013
- Study completionJul 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 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 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
- NCT01835353
- Sponsor's protocol ID
- PATRASCARDIOLOGY-13
- Status last verified
- Sep 2013
- First submitted
- 15 Apr 2013
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexopoulos D, Makris G, Xanthopoulou I, Patsilinakos S, Deftereos S, Gkizas V, Perperis A, Karanikas S, Angelidis C, Tsigkas G, Koutsogiannis N, Hahalis G, Davlouros P. Onset of antiplatelet action with high (100 mg) versus standard (60 mg) loading dose of prasugrel in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention: pharmacodynamic study. Circ Cardiovasc Interv. 2014 Apr;7(2):233-9. doi: 10.1161/CIRCINTERVENTIONS.113.001118. Epub 2014 Mar 25.
PubMed 24668226
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT01835353
- Acronym / sponsor ID
- PATRASCARDIOLOGY-13
- Conditions
- Platelet Reactivity
- Keywords
- prasugrel, ST elevation myocardial infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Apr 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.
This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin 325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel 100mg loading dose | Experimental | Drug: Prasugrel 100mg loading dosePrasugrel 100mg loading dose |
| Prasugrel 60mg loading dose | Active comparator | Drug: Prasugrel 60mg loading dose |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ST elevation myocardial infarction
- Pain onset <12 hours
- Age >18 and <75 years
- Written informed consent
Key exclusion criteria (10 listed)
- history of stroke/transient ischemic attack
- oral anticoagulation
- hemodynamic instability
- platelet count <100000/μL
- hematocrit <30%
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 |
|---|---|---|
| Prasugrel 100mg loading dose | Drug | Prasugrel 100mg loading dose |
| Prasugrel 60mg loading dosePrasugrel 60mg loading dose | Drug | Prasugrel 60mg loading dose |
Primary outcome
Platelet reactivity in Platelet reactivity units (PRU) at Hour 2
Time frame: 2 hours
Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization
7 secondary outcomes
Platelet reactivity in platelet reactivity units (PRU)at hour 1
Time frame: 1 hour
Platelet reactivity in platelet reactivity units (PRU)at hour 0.5
Time frame: 0.5 hours
Platelet reactivity in platelet reactivity units (PRU)at hour 4
Time frame: 4 hours
High platelet reactivity rate (208 PRU threshold) at 0.5 hour
Time frame: 0.5 hour
High platelet reactivity rate (208 PRU threshold) at 1 hour
Time frame: 1 hour
High platelet reactivity rate (208 PRU threshold) at 2 hour
Time frame: 2 hours
High platelet reactivity rate (208 PRU threshold) at 4 hour
Time frame: 4 hours
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 23 Sep 2013.
- Derived from this study: PubMed 24668226Alexopoulos D, Makris G, Xanthopoulou I, Patsilinakos S, Deftereos S, Gkizas V, Perperis A, Karanikas S, Angelidis C, Tsigkas G, Koutsogiannis N, Hahalis G, Davlouros P. Onset of antiplatelet action with high (100 mg) versus standard (60 mg) loading dose of prasugrel in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention: pharmacodynamic study. Circ Cardiovasc Interv. 2014 Apr;7(2):233-9. doi: 10.1161/CIRCINTERVENTIONS.113.001118. Epub 2014 Mar 25.
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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 3 study testing Prasugrel 100mg loading dose and Prasugrel 60mg loading dose 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 4 inclusion and 10 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 23 Sep 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 in Platelet reactivity units (PRU) at Hour 2 (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 NCT01835353, 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 23 Sep 2013.