Influence of PRU Values on Primary OutcomePRECLOPNCT01744613
High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures
An observational study of Influence of PRU Values on Primary Outcome, run by University of Patras at 1 site in Greece.
Trial summary
Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular procedures. The clinical significance of an inadequate response to clopidogrel following percutaneous coronary interventions has been recently recognized.This study was designed to investigate platelet responsiveness to Clopidogrel… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Influence of PRU Values on Primary Outcome
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2010to Jan 2013
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patient sampling of all patients undergoing pre-scheduled infrainguinal angioplasty or stenting due to symptomatic arterial disease in our Department from January 2010, treated with clopidogrel 75 mg daily.
Who may be able to join
- Patients suffering from Rutherford 3-6 stage of peripheral arterial disease scheduled to undergo femoropopliteal or and infrapopliteal angioplasty or stenting.
- Patients receiving Clopidogrel per os 75 mg daily at least 1 month prior and 1 year after the procedure.
Who cannot join
- Acute limb ischemia
- Coagulation disorders
- Known allergy to clopidogrel
- Failure to comply with the antiplatelet treatment protocol
- Aortoiliac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Impact of High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures. The PRECLOP Study (Platelet REsponsiveness to CLOpidogrel Treatment After Peripheral Angioplasty or Stenting)
Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular procedures. The clinical significance of an inadequate response to clopidogrel following percutaneous coronary interventions has been recently recognized.This study was designed to investigate platelet responsiveness to Clopidogrel following endovascular therapy of peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel antiplatelet therapy.
- Keywords
- Clopidogrel, platelet inhibition, antiplatelet therapy, peripheral arterial disease, endovascular treatment, angioplasty, stenting
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Will include patients with PRU values above the optimal cut-off value determined by ROC analysis | |
| Group B | Will include patients with PRU values below the optimal cut-off value determined by ROC analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major event-free survival
12 months freedom from all causes of death, stroke, index limb amputation, non pre-scheduled minor amputation, index limb bypass surgery and target vessel recanalization (TVR)stratified according to PRU values distribution
Measured: 12 months
Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition
Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition measured with VerifyNow P2Y12 assay point-of-care testing, influencing the 12 months primary outcome of major event-free survival estimated by ROC analysis
Measured: 12 months
Secondary outcomes (2)
Positive and negative predictive value of PRU testing
Positive and negative predictive value of PRU measurement with regard to the primary outcome of major event-free survival
Measured: 12 months
Bleeding rate
12-months bleeding rate including intracranial hemorrhage and puncture related pseudoaneurysm stratified according to PRU values
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 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 Influence of PRU Values on Primary OutcomeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SIABLIS DIMITRIOS, University of Patras
- Investigators
- Dimitrios Siablis, MD, PhD, Study director, University Hospital of PatrasDimitrios Karnabatidis, MD, PhD, Principal investigator, University Hospital of PatrasStavros Spiliopoulos, MD, PhD, Principal investigator, University Hospital of PatrasGeorgios Pastromas, MD, Principal investigator, University Hospital of PatrasKonstantinos Katsanos, MD, PhD, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744613
- Sponsor's protocol ID
- 822
- Acronym
- PRECLOP
- Status last verified
- Jan 2013
- First submitted
- 5 Dec 2012
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Spiliopoulos S, Pastromas G, Katsanos K, Kitrou P, Karnabatidis D, Siablis D. Platelet responsiveness to clopidogrel treatment after peripheral endovascular procedures: the PRECLOP study: clinical impact and optimal cutoff value of on-treatment high platelet reactivity. J Am Coll Cardiol. 2013 Jun 18;61(24):2428-2434. doi: 10.1016/j.jacc.2013.03.036. Epub 2013 Apr 16.
PubMed 23602777
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures. The PRECLOP Study (Platelet REsponsiveness to CLOpidogrel Treatment After Peripheral Angioplasty or Stenting)
- ClinicalTrials.gov ID
- NCT01744613
- Acronym / sponsor ID
- PRECLOP / 822
- Keywords
- Clopidogrel, platelet inhibition, antiplatelet therapy, peripheral arterial disease, endovascular treatment, angioplasty, stenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 6 Dec 2012 (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.
Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular procedures. The clinical significance of an inadequate response to clopidogrel following percutaneous coronary interventions has been recently recognized.This study was designed to investigate platelet responsiveness to Clopidogrel following endovascular therapy of peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel antiplatelet therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Will include patients with PRU values above the optimal cut-off value determined by ROC analysis |
| Group B | – | –Will include patients with PRU values below the optimal cut-off value determined by ROC analysis. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patient sampling of all patients undergoing pre-scheduled infrainguinal angioplasty or stenting due to symptomatic arterial disease in our Department from January 2010, treated with clopidogrel 75 mg daily.
Key inclusion criteria (2 listed)
- Patients suffering from Rutherford 3-6 stage of peripheral arterial disease scheduled to undergo femoropopliteal or and infrapopliteal angioplasty or stenting.
- Patients receiving Clopidogrel per os 75 mg daily at least 1 month prior and 1 year after the procedure.
Key exclusion criteria (5 listed)
- Acute limb ischemia
- Coagulation disorders
- Known allergy to clopidogrel
- Failure to comply with the antiplatelet treatment protocol
- Aortoiliac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major event-free survival
Time frame: 12 months
12 months freedom from all causes of death, stroke, index limb amputation, non pre-scheduled minor amputation, index limb bypass surgery and target vessel recanalization (TVR)stratified according to PRU values distribution
Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition
Time frame: 12 months
Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition measured with VerifyNow P2Y12 assay point-of-care testing, influencing the 12 months primary outcome of major event-free survival estimated by ROC analysis
2 secondary outcomes
Positive and negative predictive value of PRU testing
Time frame: 12 months
Bleeding rate
Time frame: 12 months
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 14 Jan 2013.
- Derived from this study: PubMed 23602777Spiliopoulos S, Pastromas G, Katsanos K, Kitrou P, Karnabatidis D, Siablis D. Platelet responsiveness to clopidogrel treatment after peripheral endovascular procedures: the PRECLOP study: clinical impact and optimal cutoff value of on-treatment high platelet reactivity. J Am Coll Cardiol. 2013 Jun 18;61(24):2428-2434. doi: 10.1016/j.jacc.2013.03.036. Epub 2013 Apr 16.
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.
Dimitrios Siablis, MD, PhD study director
University Hospital of Patras
Dimitrios Karnabatidis, MD, PhD principal investigator
University Hospital of Patras
Stavros Spiliopoulos, MD, PhD principal investigator
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influence of PRU Values on Primary Outcome, 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 2 inclusion and 5 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 14 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 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.
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?
Major event-free survival (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01744613, 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 14 Jan 2013.