Clinical trial NCT04269863: Personalizing Aspirin Therapy in Peripheral Arterial Disease Patients
Official title: Personalizing Antiplatelet Therapy in Peripheral Arterial Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Aspirin
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2020-02-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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)
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: PAD disease progression
timeFrame: 1 year
measure: development of Critical limb ischemia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
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Study officials:
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