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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
Peripheral arterial disease
Planned angioplasty or stenting of superficial femoral artery or popliteal artery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year from intervention
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Study 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
Select...
I have peripheral arterial disease.
Select...
I am scheduled for a procedure to open arteries in my leg.

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians invited to participate in this clinical trial?

"This clinical trial includes patients that are aged 18 to 90. If the patient is under 18, there are 18 other trials they could potentially enroll in. If the patient is over 65, there are 350 other trials they could potentially enroll in."

Answered by AI

How effective is Point of care screening for HPR in detecting health risks?

"There is already some evidence that this point of care screening for HPR is effective, and multiple rounds of data have shown that it is safe, so we give it a 3."

Answered by AI

What medical condition does Point of care screening for HPR usually target?

"Point of care screening for HPR can be used to cerebrovascular accident, as well as coronary artery disease, myocardial infarction, and other high risk cardiac conditions."

Answered by AI

Are there other examples in the medical community of using Point of care screening for HPR?

"At the moment, there are 45 ongoing studies related to point-of-care screening for HPR. Out of these, 12 are phase 3 trials. Most of the clinical trials are taking place in San Diego, California; however, there are a total of 592 locations running these studies."

Answered by AI

Could you please walk me through the requirements for joining this particular clinical trial?

"This clinical trial is open to individuals with peripheral arterial disease (PAD) that fall in the age range of 18 to 90 years old. They are expecting to enroll around 296 total participants."

Answered by AI

Are there any participant openings in this research project?

"The clinical trial is currently looking for volunteers, as noted on the website clinicaltrials.gov. The trial was first posted on August 9th, 2019 and the most recent update was on November 1st, 2022."

Answered by AI
~46 spots leftby Dec 2024