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Personalizing Aspirin Therapy in Peripheral Arterial Disease Patients

Personalizing Antiplatelet Therapy in Peripheral Arterial Disease Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04269863
Enrollment
150
Registered
2020-02-17
Start date
2020-11-01
Completion date
2021-11-30
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

Aspirin

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.

Interventions

DRUGAspirin

control - 81mg. treatment - 81-325mg.

Sponsors

University of Toronto
CollaboratorOTHER
Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PAD disease progression1 yearUsing 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.
development of Critical limb ischemia1 yearCritical limb ischemia will considered as those patients who have progressed from claudication to night paint, rest pain, and/or tissue loss.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026