← Back to Search

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

Select...

I am scheduled for a procedure to open arteries in my leg.

Select...

I have peripheral arterial disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My surgery is not on the superficial femoral or popliteal artery.

Select...

I am currently taking blood thinner pills.

Select...

I am currently taking prasugrel or ticlopidine.

Select...

I am scheduled for a procedure on a site previously operated on.

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year from intervention

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with primary patency

Secondary study objectives

Correlation of HPR testing results

Major adverse cardiovascular events

proportion of participants with amputation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 8Eligibility criteria met