Platelet ReactivityPhase 4NCT01463150
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
A Phase 4 study testing Clopidogrel and Prasugrel in people with Platelet Reactivity, run by University of Patras at 1 site in Greece.
Trial summary
The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. 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?
- Clopidogrel and Prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2011to Jul 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 having PCI with stenting 24 hours prior randomization, meeting the following criteria :
- Acute coronary syndrome (unstable angina or myocardial infarction)
- TIMI risk score>2
- Platelet reactivity in PRU ≥235 24 hours post-PCI
- Age≥75 years and/or weight<60 Kg
- 4. Informed consent obtained in writing
Who cannot join
- A history of bleeding diathesis
- Chronic oral anticoagulation treatment
- Contraindications to antiplatelet therapy
- Known platelet function disorders
- PCI or coronary artery bypass surgery < 3 months
- Unsuccessful PCI (residual stenosis > 30% or flow < Thrombolysis in myocardial infarction flow 3)
Show all 19Show fewer
- Planned staged PCI in the next 30 days
- Hemodynamic instability
- hemodialysis
- Creatinine clearance <25 ml/min
- inability to give informed consent
- High likelihood of being unavailable for the Day 30
- 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 on longterm antiplatelet therapy.
- Any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thrombocytopenia (<100.000 / μL) at randomization
- Anaemia (Hct <30%) at randomization
- Polycythaemia (Hct > 52%) at randomization
- Periprocedural IIb/IIIa inhibitor administration
Trial locations and contacts
1 site in 1 country.
Greece1 site
Cardiology Department Patras University Hospital
Rio, Achaia, 26500
About this study
The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. The aim of the study is to define in consecutive patients with acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24 hours post PCI with the VerifyNow assay. Those patients will be randomized after informed concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet reactivity will be determined as well.
- Conditions
- Platelet Reactivity
- Being tested
- Clopidogrel, Prasugrel
- Keywords
- Platelet reactivity, Clopidogrel, Prasugrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Clopidogrel 150mg per day for 15 days
PrasugrelDrug
Prasugrel 5mg per day for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | Clopidogrel 150mg per day for 15 days Receives: Drug: Clopidogrel |
| Prasugrel | Experimental | Prasugrel 5mg for 15 days Receives: Drug: Prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period
Measured: 15 days
Secondary outcomes (1)
Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods
Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug
Measured: 15 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 completionJul 2012
- Study completionJul 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 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
- NCT01463150
- Sponsor's protocol ID
- PATRASCARDIOLOGY-7
- Status last verified
- Apr 2012
- First submitted
- 27 Oct 2011
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexopoulos D, Xanthopoulou I, Plakomyti TE, Theodoropoulos KC, Mavronasiou E, Damelou A, Hahalis G, Davlouros P. Pharmacodynamic effect of prasugrel 5 mg vs clopidogrel 150 mg in elderly patients with high on-clopidogrel platelet reactivity. Am Heart J. 2013 Jan;165(1):73-9. doi: 10.1016/j.ahj.2012.10.008. Epub 2012 Nov 14.
PubMed 23237136
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT01463150
- Acronym / sponsor ID
- PATRASCARDIOLOGY-7
- Conditions
- Platelet Reactivity
- Keywords
- Platelet reactivity, Clopidogrel, Prasugrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 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.
The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. The aim of the study is to define in consecutive patients with acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24 hours post PCI with the VerifyNow assay. Those patients will be randomized after informed concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet reactivity will be determined as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel 150mg per day for 15 days |
| Prasugrel | Experimental | Drug: PrasugrelPrasugrel 5mg for 15 days |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years old
- Patients having PCI with stenting 24 hours prior randomization, meeting the following criteria :
- Platelet reactivity in PRU ≥235 24 hours post-PCI
- Age≥75 years and/or weight<60 Kg
- 4. Informed consent obtained in writing
Key exclusion criteria (19 listed)
- A history of bleeding diathesis
- Chronic oral anticoagulation treatment
- Contraindications to antiplatelet therapy
- Known platelet function disorders
- PCI or coronary artery bypass surgery < 3 months
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 |
|---|---|---|
| ClopidogrelClopidogrel 150mg per day for 15 days | Drug | Clopidogrel |
| PrasugrelPrasugrel 5mg per day for 15 days | Drug | Prasugrel |
Primary outcome
Platelet reactivity
Time frame: 15 days
Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period
1 secondary outcome
Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods
Time frame: 15 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 11 Jul 2012.
- Derived from this study: PubMed 23237136Alexopoulos D, Xanthopoulou I, Plakomyti TE, Theodoropoulos KC, Mavronasiou E, Damelou A, Hahalis G, Davlouros P. Pharmacodynamic effect of prasugrel 5 mg vs clopidogrel 150 mg in elderly patients with high on-clopidogrel platelet reactivity. Am Heart J. 2013 Jan;165(1):73-9. doi: 10.1016/j.ahj.2012.10.008. Epub 2012 Nov 14.
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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 Clopidogrel and Prasugrel 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 7 inclusion and 19 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 11 Jul 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: 15 days). 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 NCT01463150, 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 11 Jul 2012.