Peripheral Arterial DiseaseNCT04269863
Personalizing Aspirin Therapy in Peripheral Arterial Disease Patients
A study testing Aspirin in people with Peripheral Arterial Disease, run by Unity Health Toronto.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported intake of either 81 mg of aspirin per day for 3 or more days
- Diagnosed with peripheral arterial disease
Who cannot join
- 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
About this study
Official title: Personalizing Antiplatelet Therapy in Peripheral Arterial Disease Patients
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Aspirin
- Keywords
- Aspirin
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
control - 81mg. treatment - 81-325mg.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | This group of 75 patients is the control group that will be receiving the standard lowest dosage of 81mg aspirin. Receives: Drug: Aspirin |
| Treatment Group | Experimental | 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. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Nov 2020 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Mohammad, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269863
- Sponsor's protocol ID
- 19-241
- Status last verified
- Oct 2020
- First submitted
- 12 Feb 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Antiplatelet Therapy in Peripheral Arterial Disease Patients
- ClinicalTrials.gov ID
- NCT04269863
- Acronym / sponsor ID
- 19-241
- Conditions
- Peripheral Arterial Disease
- Keywords
- Aspirin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Drug: AspirinThis group of 75 patients is the control group that will be receiving the standard lowest dosage of 81mg aspirin. |
| Treatment Group | Experimental | Drug: AspirinThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-reported intake of either 81 mg of aspirin per day for 3 or more days
- Diagnosed with peripheral arterial disease
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirincontrol - 81mg. treatment - 81-325mg. | Drug | Control Group, Treatment Group |
Primary outcome
PAD disease progression
Time frame: 1 year
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.
development of Critical limb ischemia
Time frame: 1 year
Critical limb ischemia will considered as those patients who have progressed from claudication to night paint, rest pain, and/or tissue loss.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin in people with Peripheral Arterial Disease, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAD disease progression (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.