The Value of Screening for HPR in Patients Undergoing Lower Extremity Arterial Endovascular Interventions

NCT04007055 | Terminated Phase 3 Results FDA Drug FDA Device

• 1 other identifier: STUDY19030453
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial designed to evaluate the role of screening for and intervening on patients with high on treatment platelet reactivity undergoing lower extremity arterial endovascular interventions.

Conditions

Artery Disease; Peripheral Artery Disease; Clopidogrel, Poor Metabolism of; Peripheral Vascular Disease; Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Primary Patency

  primary patency is freedom from re-intervention, freedom from complete vessel occlusion, freedom from \>50% restenosis with duplex ultrasound or freedom from \>70% restenosis with computed tomography angiography

  one year from intervention

Secondary Outcomes (3)

• Amputation

  one year from intervention

• Major Adverse Cardiovascular Events

  one year from intervention

• Correlation of HPR Testing Results

  after study completion, 1 year

Study Arms (2)

Experimental: screening/treating for HPR

EXPERIMENTAL

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.

Diagnostic Test: Point of care screening for HPR; Drug: Ticagrelor 90mg

Control: guideline based therapy

NO 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.

Interventions

Point of care screening for HPR DIAGNOSTIC_TEST

HPR testing using VerifyNow testing system. HPR is defined platelet reactivity units are greater than 234

Experimental: screening/treating for HPR

Ticagrelor 90mg DRUG

Participants who test positive for HPR will be prescribed ticagrelor 90mg twice daily instead of standard therapy with clopidogrel 75mg daily

Experimental: screening/treating for HPR

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peripheral arterial disease
• Planned angioplasty or stenting of superficial femoral artery or popliteal artery.

You may not qualify if:

• Patients treated on an emergency basis
• Planned intervention on prior site of open surgical intervention (autogenous or autologous bypass, endarterectomy, or patch angioplasty)
• Planned intervention at site exclusive of superficial femoral artery or popliteal artery
• Planned re-stenting at site of prior stent placement
• Planned re-angioplasty at site of prior angioplasty
• Known inability to tolerate antiplatelet regimen before enrollment
• Patients who plan on receiving follow up care outside the University of Pittsburgh Medical Center
• Current use of prasugrel or ticlopidine
• Current use of oral anticoagulation medication
• Pregnant patients

Sponsors & Collaborators

• Marissa Jarosinski: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Peripheral Arterial Occlusive Disease 1

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Marissa Jarosinski, MD
• Organization: University of Pittsburgh

jarosinskimc@upmc.edu

9084005771

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident in Vascular Surgery

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: August 9, 2019
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2024
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)