Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04165629
Status:
UNKNOWN
Last Update Posted:
2020-07-15
First Post:
2019-11-14
Brief Title:
Platelet Reactivity in PAD Undergoing Percutaneous Angioplasty
Sponsor:
Clinical Centre of Serbia
Organization:
Clinical Centre of Serbia
Study Overview
Official Title:
Influence of Platelet Reactivity in Peripheral Arterial Disease Patients Undergoing Percutaneous Angioplasty on Mid-term Outcomes
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAD
Brief Summary:
Dual antiplatelet therapy has a key role in a prevention of thrombosis of treated artery in patients undergoing percutaneous transluminal angioplasty PTA Weak therapeutic response and presence of residual platelet activity is related to high risk for stent thrombosis and it is well in known in coronary artery disease CAD patients undergoing percutaneous coronary intervention PCI However there are few data on the association between a different entity of platelet inhibition on antiplatelet treatment and clinical outcomes in patients with peripheral artery disease PAD The aim of this study was to evaluate the degree of on-treatment platelet reactivity and its association with ischemic and hemorrhagic adverse events at follow up in PAD patients undergoing PTA
Detailed Description:
This is a single-center observational cohort study All together 450 patients undergoing and elective PTA both with and without stenting who are going to be refereed to the Clinic for Vascular and Endovascular Surgery based on the previous experience during the two year period January 1st 2020 and January 1st 2022 are planned to be involved in this study All interventions will be performed according to the current standards and the type of the endovascular procedure will be at the discretion of operator All patients will receive at the day of treatment 300mg of Aspirin and 300mg of Clopidogrel The day after the procedure platelet function will be assessed by point-of-care impedance aggregometry test using the Multiplate analyzer According to the manufacturer proposition resistancy on Aspirin will be defined as arachidonic acid receptor ASPI value 600 and ASPIthrombin receptor activating peptide TRAP 05 and for Clopidogrel adenosine diphosphate ADP 500 and ADPTRAP 05 After that patients will receive dual antiplatelet therapy Aspirin 100mg and Clopidogrel 75mg in the six months period Follow-up examinations will be scheduled on 1 6 and 12 months after the intervention Adherence to antiplatelet treatment will assessed during scheduled or unscheduled examinations Statistical analysis will be performed using the software package SPSS 20 SPSS Inc Chicago Il USA Categorical data will be represented as numbers and percentages Chi-square test or Fisher exact test as appropriate will be used to compare categorical data Continuous variables will be represented as mean standard deviation and as median and interquartile range depending on the normality of data Students t test or Mann-Whitney U test as appropriate will be used to compare two population groups We will then assess the ability of ASPI and ADP values to distinguish between patients with and without clinical event at 6 months follow up by receiver-operating characteristic ROC curve analysis and the optimal cut-off ASPI and ADP values will be determined by estimating the value resulting in the maximum sum of sensitivity and specificity area under the curve - AUC Kaplan-Meier curves with log-rank test will be used to assess difference in the time-to-event end-points A multivariable Cox proportional hazard model adjusted for clinical and laboratory variables will be performed to evaluate the independent contribution of platelet hyper- or hypo-reactivity to the outcomes A P-values 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None