An observational study in Peripheral Artery Disease, Critical Limb Ischemia and Claudication, Intermittent, sponsored by Clinical Centre of Serbia. Status unknown at 1 site in Serbia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Clinical Centre of Serbia · Observational
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.
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 ASPI/thrombin receptor activating peptide (TRAP) \< 0.5, and for Clopidogrel adenosine diphosphate (ADP) \< 500 and ADP/TRAP \< 0.5 . 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. Student's 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 \<0.05 will be considered statistically significant.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 450 is above the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Clinical Centre of Serbia is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
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All patients treated at the Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia, Belgrade due to PAD (critical limb ischemia {CLI} or intermittent claudication {IC}) with PTA with/without stenting of aorto-iliac, femoro-popliteal and crural disease between January 1st 2020 and January 1st 2022
Exclusion Criteria:
On impedance aggregometry- Multiplate analyzer, if ASPI \< 600 or ASPI/TRAP \< 0.5
Drug: Aspirin 300mg and Clopidogrel 300mg
On impedance aggregometry- Multiplate analyzer, if ASPI \> 600 or ASPI/TRAP \> 0.5
Drug: Aspirin 300mg and Clopidogrel 300mg
On impedance aggregometry- Multiplate analyzer, if ADP \< 500 or ADP/TRAP \< 0.5
Drug: Aspirin 300mg and Clopidogrel 300mg
On impedance aggregometry- Multiplate analyzer, if ADP \> 500 or ADP/TRAP \> 0.5
Drug: Aspirin 300mg and Clopidogrel 300mg
Aspirin 300mg and Clopidogrel 300mg on the day of the PTA
Major Adverse Limb Event (MALE)
It includes major amputation, reintervention which could be surgical or repeat angioplasty. Major amputation is defined as amputation above the ankle.
Time frame: 6 months
Mortality
All-cause mortality
Time frame: 6 months
Major Adverse Cardio- and Cerebrovascular Events (MACCE)
Nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Time frame: 6 months
Bleeding complications
Major and minor bleeding
Time frame: 6 months
Plan to share: Undecided — to be available on request for now
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Clinical Centre of Serbia