Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Bleeding rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitrios Siablis, MD, PhD | University Hospital of Patras | Study Director |
| Dimitrios Karnabatidis, MD, PhD | University Hospital of Patras | Principal Investigator |
| Stavros Spiliopoulos, MD, PhD | University Hospital of Patras | Principal Investigator |
| Georgios Pastromas, MD | University Hospital of Patras | Principal Investigator |
| Konstantinos Katsanos, MD, PhD | University Hospital of Patras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patras University Hospital | Rio | Achaia | 26500 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23602777 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
12-months bleeding rate including intracranial hemorrhage and puncture related pseudoaneurysm stratified according to PRU values
| 12 months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |