Coronary Artery DiseasePhase 4NCT01201772
Prasugrel Re-load Strategies
A Phase 4 study testing Prasugrel in people with Coronary Artery Disease, run by University of Florida at 1 site in United States.
Trial summary
A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with angiographically documented coronary artery disease.
- Age between 18 to 74 years
- On treatment with prasugrel 10mg/daily for at least 14 days.
Who cannot join
- Blood dyscrasias or bleeding diathesis
- Antiplatelet treatment with clopidogrel or ticlopidine
- Recent antiplatelet treatment (< 14 days) with a glycoprotein IIb/IIIa antagonist
- Platelet count <100x106/µL
- Active bleeding or hemodynamic instability.
- Unstable angina, acute or recent (<14 days) myocardial infarction.
Show all 12Show fewer
- Serum creatinine >2 mg/dL
- Baseline ALT >2.5 times the upper limit of normal
- Oral anticoagulation with a coumarin derivative
- History of stroke, TIA or intracranial bleeding
- Weight <60kg
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy
A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior observations showing that higher inhibition of platelet aggregation may be achieved by giving a loading dose of clopidogrel in patients with coronary artery disease while on chronic clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet aggregation can be achieved by adding a prasugrel loading dose in patients on chronic prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel re-load strategy in patients on already on chronic prasugrel therapy will be useful.
- Conditions
- Coronary Artery Disease
- Being tested
- Prasugrel
- Keywords
- coronary artery disease, percutaneous coronary revascularization, prasugrel therapy
- 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, 30mg, or 60mg
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel 60mg | Active comparator | Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel Receives: Drug: Prasugrel |
| Prasugrel 30mg | Active comparator | Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel Receives: Drug: Prasugrel |
| Prasugrel 10mg | No intervention | Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRI Levels at 4 Hours
Measured: 4 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominick Angiolillo, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201772
- Sponsor's protocol ID
- UFJ 2010-49
- Status last verified
- Dec 2011
- First submitted
- 3 Sep 2010
- Last updated
- 18 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tello-Montoliu A, Tomasello SD, Ferreiro JL, Ueno M, Seecheran N, Desai B, Kodali M, Charlton RK, Box LC, Zenni MM, Guzman LA, Bass TA, Angiolillo DJ. Pharmacodynamic effects of prasugrel dosing regimens in patients on maintenance prasugrel therapy: results of a prospective randomized study. J Am Coll Cardiol. 2012 May 8;59(19):1681-7. doi: 10.1016/j.jacc.2011.12.039.
PubMed 22554598
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy
- ClinicalTrials.gov ID
- NCT01201772
- Acronym / sponsor ID
- UFJ 2010-49
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, percutaneous coronary revascularization, prasugrel therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Posted 18 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior observations showing that higher inhibition of platelet aggregation may be achieved by giving a loading dose of clopidogrel in patients with coronary artery disease while on chronic clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet aggregation can be achieved by adding a prasugrel loading dose in patients on chronic prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel re-load strategy in patients on already on chronic prasugrel therapy will be useful.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prasugrel 60mg | Active comparator | Drug: PrasugrelPatients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel |
| Prasugrel 30mg | Active comparator | Drug: PrasugrelPatients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel |
| Prasugrel 10mg | No intervention | –Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with angiographically documented coronary artery disease.
- Age between 18 to 74 years
- On treatment with prasugrel 10mg/daily for at least 14 days.
Key exclusion criteria (12 listed)
- Blood dyscrasias or bleeding diathesis
- Antiplatelet treatment with clopidogrel or ticlopidine
- Recent antiplatelet treatment (< 14 days) with a glycoprotein IIb/IIIa antagonist
- Platelet count <100x106/µL
- Active bleeding or hemodynamic instability.
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, 30mg, or 60mg | Drug | Prasugrel 30mg, Prasugrel 60mg |
Primary outcome
PRI Levels at 4 Hours
Time frame: 4 hours after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22554598Tello-Montoliu A, Tomasello SD, Ferreiro JL, Ueno M, Seecheran N, Desai B, Kodali M, Charlton RK, Box LC, Zenni MM, Guzman LA, Bass TA, Angiolillo DJ. Pharmacodynamic effects of prasugrel dosing regimens in patients on maintenance prasugrel therapy: results of a prospective randomized study. J Am Coll Cardiol. 2012 May 8;59(19):1681-7. doi: 10.1016/j.jacc.2011.12.039.
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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.
Dominick Angiolillo, MD, PhD principal investigator
University of Florida
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 in people with Coronary Artery Disease, run by University of Florida at 1 site in United States.
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 12 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 18 Jan 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PRI Levels at 4 Hours (time frame: 4 hours after treatment). 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 NCT01201772, 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 18 Jan 2013.