Personalizing Aspirin Therapy in Peripheral Arterial Disease Patients

Study Overview
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Brief Summary
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Antiplatelet therapies are important to decrease the morbidity and mortality associated with Peripheral Arterial Disease (PAD) through the prevention of thrombus formation. Aspirin (ASA) is a readily available and affordable antiplatelet medication that can help reduce adverse cardiovascular events by up to 25%. However, 25-60% of PAD patients are ASA insensitive having a lower than normal ability to inhibit platelet aggregation after standard aspirin dosing. In a previous study conducted by our lab, we were able to demonstrate a methodology for personalizing antiplatelet therapy using two platelet function tests, Platelet Function Analyzer-100 (PFA 100) and Light Transmission Aggregometry (LTA). To investigate this methodology further, we would like to conduct a pilot study on two cohorts of patients, one population continuing with their current medications (81mg ASA), and a second group who will get personalized antiplatelet therapy using our methodology (81-325mg ASA). In this study, 150 PAD patients taking 81mg Aspirin therapy presenting for clinical follow-up, or in-patient intervention, in vascular clinics or the emergency room, will be recruited to our study. 75 patients will be randomly assigned undergo platelet analysis using PFA-200 and LTA, and will have their antiplatelet therapy personalized. Patients will then be followed up in order to see if the patients with personalized therapy have better platelet inhibition. This study will allow us to help personalize antiplatelet therapy in PAD patients, allowing for better patient outcomes and decreased adverse cardiovascular events.

Official Title
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Personalizing Antiplatelet Therapy in Peripheral Arterial Disease Patients

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported intake of either 81 mg of aspirin per day for 3 or more days Diagnosed with peripheral arterial disease Exclusion Criteria: Alcohol ingestion 24 hours prior to blood draw Patients receiving glycoprotein (GP) IIb/IIIa antagonists Ingestion of a non steroidal anti-inflammatory drug 3 days prior to blood draw History of bleeding disorders Gastrointestinal bleeding Hemorrhagic stroke Allergy to aspirin or ticagrelor Pregnancy, thrombocytopenia anmia or leukopenia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 150 patients randomized into two groups of 75 patients each, one control group receiving 81mg ASA and treatment group receiving a personalized dose of unto 325mg (within the recommended dosage limits)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>This group of 75 patients is the control group that will be receiving the standard lowest dosage of 81mg aspirin. | Drug: Aspirin<br>* control - 81mg. treatment - 81-325mg.<br>|
| Experimental: Treatment Group<br>This group of 75 participants is the treatment group that will be receiving personalized aspirin dosage between 81mg-325mg (within standard clinical recommendations), which will be determined based on platelet analysis via PFA-200. | Drug: Aspirin<br>* control - 81mg. treatment - 81-325mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAD disease progression | Using lower limb arterial imaging (doppler ultra sound), and ankle brachial index, patients will be categorized based on Ruthorford Classification of chronic limb ischemia. Progression of PAD will be considered decrease in ABI, and progression to more sever forms according to the Rutherford classification. | 1 year | 
| development of Critical limb ischemia | Critical limb ischemia will considered as those patients who have progressed from claudication to night paint, rest pain, and/or tissue loss. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspirin