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P2Y12 Inhibitor

Ticagrelor and HPR Screening for Peripheral Arterial Disease

Phase 3
Recruiting
Research Sponsored by Kyle Markel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned angioplasty or stenting of superficial femoral artery or popliteal artery.
Peripheral arterial disease
Must not have
Planned intervention at site exclusive of superficial femoral artery or popliteal artery
Current use of oral anticoagulation medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year from intervention
Awards & highlights

Summary

This trial is testing whether screening for and intervening on patients with high on treatment platelet reactivity undergoing lower extremity arterial endovascular interventions can improve outcomes.

Who is the study for?
This trial is for individuals with peripheral arterial disease who are scheduled for angioplasty or stenting of the superficial femoral artery or popliteal artery. It's not open to those on oral anticoagulants, pregnant women, patients with prior surgical interventions at the same site, or those unable to tolerate antiplatelet drugs.Check my eligibility
What is being tested?
The study tests if screening and treating high platelet reactivity (HPR) with Ticagrelor can benefit patients undergoing lower extremity arterial endovascular procedures. Participants will be randomly assigned to receive either HPR screening followed by treatment or no screening.See study design
What are the potential side effects?
Ticagrelor may cause bleeding, shortness of breath, headache, dizziness, nausea, and increased risk of bruising. The point-of-care HPR screening itself has minimal side effects but informs medication adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a procedure to open arteries in my leg.
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I have peripheral arterial disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My surgery is not on the superficial femoral or popliteal artery.
Select...
I am currently taking blood thinner pills.
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I am currently taking prasugrel or ticlopidine.
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I am scheduled for a procedure on a site previously operated on.
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I am scheduled for a procedure to replace or adjust a stent I already have.
Select...
I am scheduled for another angioplasty at the same site as before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year from intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year from intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with primary patency
Secondary outcome measures
Correlation of HPR testing results
Major adverse cardiovascular events
proportion of participants with amputation

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: screening/treating for HPRExperimental Treatment2 Interventions
Participants randomized to this arm will be screened and treated for HPR. Pharmacogenetics testing for CYP2C19 polymorphisms will be collected, stored, and analyzed at study completion.
Group II: Control: guideline based therapyActive Control1 Intervention
Participants randomized to this arm will receive usual care without screening for HPR. Pharmacogenetics testing for CYP2C19 polymorphisms will be collected, stored, and analyzed at study completion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ticagrelor 90mg
2021
Completed Phase 4
~58970

Find a Location

Who is running the clinical trial?

Kyle MarkelLead Sponsor
Marissa JarosinskiLead Sponsor
Rohan KulkarniLead Sponsor

Media Library

Ticagrelor 90mg (P2Y12 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04007055 — Phase 3
Peripheral Arterial Disease Research Study Groups: Experimental: screening/treating for HPR, Control: guideline based therapy
Peripheral Arterial Disease Clinical Trial 2023: Ticagrelor 90mg Highlights & Side Effects. Trial Name: NCT04007055 — Phase 3
Ticagrelor 90mg (P2Y12 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04007055 — Phase 3
~23 spots leftby Dec 2024
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