Coronary Artery Disease (CAD)Phase 3NCT01109784
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).
A Phase 3 study testing prasugrel and clopidogrel in people with Coronary Artery Disease (CAD) and Acute Coronary Syndrome (ACS), 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 80 years
- Conditions the study is for
- Coronary Artery Disease (CAD), Acute Coronary Syndrome (ACS)
- What is being tested?
- prasugrel and clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2010to Jul 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction)
- Written Informed consent
- Platelet reactivity units (PRU) (VerifyNow) >230
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 13Show fewer
- Planned staged PCI in the next 60 days
- Hemodynamic instability
- Cancer or hemodialysis
- Platelet count <100 000/ μL, hematocrit <30%
- Creatinine clearance <25 ml/min
- A life expectancy<1 year, inability to give informed consent
- High likelihood of being unavailable for the Day 60 follow up
Trial locations and contacts
1 site in 1 country.
Greece1 site
Cardiology Department, Patras University Hospital
Rio, Patras, 26500
About this study
Official title: Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.
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. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.
- Being tested
- prasugrel, clopidogrel
- Keywords
- coronary angioplasty, clopidogrel resistance, prasugrel
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prasugrelDrug
prasugrel 10 mg/day
clopidogrelDrug
clopidogrel per os 150mg/day
| Study group | Role | What they receive |
|---|---|---|
| prasugrel | Experimental | prasugrel per os 10mg/day Receives: Drug: prasugrel |
| clopidogrel | Active comparator | clopidogrel per os 150mg/day Receives: Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
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 Coronary Artery Disease (CAD)Studies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109784
- Sponsor's protocol ID
- PATRASCARDIOLOGY-1
- Status last verified
- Apr 2010
- First submitted
- 22 Apr 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexopoulos D, Dimitropoulos G, Davlouros P, Xanthopoulou I, Kassimis G, Stavrou EF, Hahalis G, Athanassiadou A. Prasugrel overcomes high on-clopidogrel platelet reactivity post-stenting more effectively than high-dose (150-mg) clopidogrel: the importance of CYP2C19*2 genotyping. JACC Cardiovasc Interv. 2011 Apr;4(4):403-10. doi: 10.1016/j.jcin.2010.12.011.
PubMed 21511219
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.
- ClinicalTrials.gov ID
- NCT01109784
- Acronym / sponsor ID
- PATRASCARDIOLOGY-1
- Keywords
- coronary angioplasty, clopidogrel resistance, prasugrel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 23 Apr 2010 (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. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prasugrel | Experimental | Drug: prasugrelprasugrel per os 10mg/day |
| clopidogrel | Active comparator | Drug: clopidogrelclopidogrel per os 150mg/day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction)
- Written Informed consent
- Platelet reactivity units (PRU) (VerifyNow) >230
Key exclusion criteria (13 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 |
|---|---|---|
| prasugrelprasugrel 10 mg/day | Drug | prasugrel |
| clopidogrelclopidogrel per os 150mg/day | Drug | clopidogrel |
Primary outcome
Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)
Time frame: Day 60
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 24 Aug 2010.
- Derived from this study: PubMed 21511219Alexopoulos D, Dimitropoulos G, Davlouros P, Xanthopoulou I, Kassimis G, Stavrou EF, Hahalis G, Athanassiadou A. Prasugrel overcomes high on-clopidogrel platelet reactivity post-stenting more effectively than high-dose (150-mg) clopidogrel: the importance of CYP2C19*2 genotyping. JACC Cardiovasc Interv. 2011 Apr;4(4):403-10. doi: 10.1016/j.jcin.2010.12.011.
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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 and clopidogrel in people with Coronary Artery Disease (CAD) and Acute Coronary Syndrome (ACS), 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 13 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 24 Aug 2010. 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 Units (PRU) assessed by VerifyNow P2Y12(Accumetrics) (time frame: Day 60). 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 NCT01109784, 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 24 Aug 2010.