Coronary Artery Disease (CAD)Phase 3NCT01304472
Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
A Phase 3 study testing Prasugrel and Clopidogrel in people with Coronary Artery Disease (CAD), run by University of Patras at 2 sites in Greece.
Trial summary
Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- Prasugrel and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesGreece
- Study dates
- Feb 2011to Apr 2011
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Patients with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment
- High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay)
- Written Informed Consent
Who cannot join
- History of bleeding diathesis
- History of active bleeding within 6 months before randomization
- Chronic oral anticoagulation treatment
- Contraindications to antiplatelet treatment
- Known platelet function disorders
- Acute coronary syndrome within 30 days before randomization
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- Cardiogenic shock
- Planned Percutaneous Coronary Intervention in the next 30 days
- Cancer
- Haemodialysis
- Platelet count < 100000/μL
- Hematocrit < 30%
- High likelihood of being unavailable on the Day 28 visit
- History of stroke
- Known allergy to clopidogrel and/or prasugrel
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Dimitrios Alexopoulos
Pátrai, 26500
Patras University Hospital Cardiology Department
Pátrai, 26500
About this study
Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. The hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment crossover will be performed without a washout period. At Day 28 platelet reactivity will be assessed as well.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- Prasugrel, Clopidogrel
- Keywords
- coronary angioplasty, clopidogrel resistance, prasugrel
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Prasugrel 10mg per day
ClopidogrelDrug
Clopidogrel 150mg per day
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Experimental | Prasugrel 10mg per day Receives: Drug: Prasugrel |
| Clopidogrel | Active comparator | Not described Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Platelet Reactivity
Platelet reactivity in Platelet Reactivity Units (PRU) as assessed with the VerifyNow point of care assay will be measured at the end of the two treatment periods, namely at 14 and 28 days after randomization
Measured: At 14 and 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 25 participants (estimated)
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
- NCT01304472
- Sponsor's protocol ID
- PATRASCARDIOLOGY-3
- Status last verified
- Aug 2011
- First submitted
- 24 Feb 2011
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
- ClinicalTrials.gov ID
- NCT01304472
- Acronym / sponsor ID
- PATRASCARDIOLOGY-3
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- coronary angioplasty, clopidogrel resistance, prasugrel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Feb 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.
Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. The hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment crossover will be performed without a washout period. At Day 28 platelet reactivity will be assessed as well.
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 10mg per day |
| Clopidogrel | Active comparator | Drug: Clopidogrel |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Patients with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment
- High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay)
- Written Informed Consent
Key exclusion criteria (15 listed)
- History of bleeding diathesis
- History of active bleeding within 6 months before randomization
- Chronic oral anticoagulation treatment
- Contraindications to antiplatelet treatment
- Known platelet function disorders
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 10mg per day | Drug | Prasugrel |
| ClopidogrelClopidogrel 150mg per day | Drug | Clopidogrel |
Primary outcome
Change in Platelet Reactivity
Time frame: At 14 and 28 days after randomization
Platelet reactivity in Platelet Reactivity Units (PRU) as assessed with the VerifyNow point of care assay will be measured at the end of the two treatment periods, namely at 14 and 28 days after randomization
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 Aug 2011.
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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.
2 sites 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), run by University of Patras at 2 sites 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 15 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 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Platelet Reactivity (time frame: At 14 and 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2011; AzTrials last refreshed its copy on 6 Nov 2026.