Trial Outcomes & Findings for The Value of Screening for HPR in Patients Undergoing Lower Extremity Arterial Endovascular Interventions (NCT NCT04007055)

Last Updated: 2026-02-13

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

31 participants

Primary outcome timeframe

one year from intervention

Results posted on

2026-02-13

Participant Flow

Participants enrolled who did not undergo the planned intervention of interest (angioplasty or stenting of the superficial femoral or popliteal artery) were excluded from baseline characteristics and outcome measures but were included in adverse event reporting.

Participant milestones

Participant milestones
Measure	Experimental: Screening/Treating for HPR 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. Point of care screening for HPR: HPR testing using VerifyNow testing system. HPR is defined platelet reactivity units are greater than 234 Ticagrelor 90mg: Participants who test positive for HPR will be prescribed ticagrelor 90mg twice daily instead of standard therapy with clopidogrel 75mg daily	Control: Guideline Based Therapy 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.
Overall Study STARTED	17	14
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PRU was not measured in the control group

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Screening/Treating for HPR n=12 Participants 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.	Control: Guideline Based Therapy n=12 Participants 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.	Total n=48 Participants Total of all reporting groups
Age, Continuous	68 years n=12 Participants	72 years n=12 Participants	71 years n=24 Participants
Sex: Female, Male Female	3 Participants n=12 Participants	3 Participants n=12 Participants	6 Participants n=24 Participants
Sex: Female, Male Male	9 Participants n=12 Participants	9 Participants n=12 Participants	18 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=12 Participants	2 Participants n=12 Participants	2 Participants n=24 Participants
Race (NIH/OMB) White	11 Participants n=12 Participants	10 Participants n=12 Participants	21 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=12 Participants	0 Participants n=12 Participants	1 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=12 Participants	12 Participants n=12 Participants	24 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Hypertension	8 Participants n=12 Participants	10 Participants n=12 Participants	18 Participants n=24 Participants
Hyperlipidemia	8 Participants n=12 Participants	9 Participants n=12 Participants	17 Participants n=24 Participants
Diabetes	5 Participants n=12 Participants	6 Participants n=12 Participants	11 Participants n=24 Participants
Coronary Artery Disease	4 Participants n=12 Participants	4 Participants n=12 Participants	8 Participants n=24 Participants
Cerebrovascular accident	3 Participants n=12 Participants	2 Participants n=12 Participants	5 Participants n=24 Participants
GFR	91 mL/min/1.73 m² n=12 Participants	68 mL/min/1.73 m² n=12 Participants	72 mL/min/1.73 m² n=24 Participants
Smoker Non-smoker	5 Participants n=12 Participants	3 Participants n=12 Participants	8 Participants n=24 Participants
Smoker Former smoker	4 Participants n=12 Participants	7 Participants n=12 Participants	11 Participants n=24 Participants
Smoker Current smoker	3 Participants n=12 Participants	2 Participants n=12 Participants	5 Participants n=24 Participants
Statin	6 Participants n=12 Participants	9 Participants n=12 Participants	15 Participants n=24 Participants
Antidepressant	0 Participants n=12 Participants	3 Participants n=12 Participants	3 Participants n=24 Participants
Rutherford 3	7 Participants n=12 Participants	5 Participants n=12 Participants	12 Participants n=24 Participants
Rutherford 4	3 Participants n=12 Participants	2 Participants n=12 Participants	5 Participants n=24 Participants
Rutherford 5	1 Participants n=12 Participants	4 Participants n=12 Participants	5 Participants n=24 Participants
Rutherford 6	0 Participants n=12 Participants	1 Participants n=12 Participants	1 Participants n=24 Participants
Rutherford Missing	1 Participants n=12 Participants	0 Participants n=12 Participants	1 Participants n=24 Participants
Treatment length <5cm	2 Participants n=12 Participants	3 Participants n=12 Participants	5 Participants n=24 Participants
Treatment length 5-9.9cm	3 Participants n=12 Participants	2 Participants n=12 Participants	5 Participants n=24 Participants
Treatment length 10-15cm	4 Participants n=12 Participants	2 Participants n=12 Participants	6 Participants n=24 Participants
Treatment length >15cm	3 Participants n=12 Participants	5 Participants n=12 Participants	8 Participants n=24 Participants
Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) A	1 Participants n=12 Participants	3 Participants n=12 Participants	4 Participants n=24 Participants
Proximal artery treated P1	2 Participants n=12 Participants	0 Participants n=12 Participants	2 Participants n=24 Participants
Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) B	4 Participants n=12 Participants	4 Participants n=12 Participants	8 Participants n=24 Participants
Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) C	5 Participants n=12 Participants	3 Participants n=12 Participants	8 Participants n=24 Participants
Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) D	2 Participants n=12 Participants	1 Participants n=12 Participants	3 Participants n=24 Participants
Proximal artery treated P2	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Proximal artery treated P3	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) Missing	0 Participants n=12 Participants	1 Participants n=12 Participants	1 Participants n=24 Participants
Vessel calcification None	6 Participants n=12 Participants	5 Participants n=12 Participants	11 Participants n=24 Participants
Vessel calcification Mild	4 Participants n=12 Participants	4 Participants n=12 Participants	8 Participants n=24 Participants
Vessel calcification Moderate	2 Participants n=12 Participants	1 Participants n=12 Participants	3 Participants n=24 Participants
Vessel calcification Severe	0 Participants n=12 Participants	2 Participants n=12 Participants	2 Participants n=24 Participants
Maximal treatment diameter	6 mm n=12 Participants	6 mm n=12 Participants	6 mm n=24 Participants
Proximal artery treated Proximal SFA	3 Participants n=12 Participants	7 Participants n=12 Participants	10 Participants n=24 Participants
Proximal artery treated Middle SFA	2 Participants n=12 Participants	2 Participants n=12 Participants	4 Participants n=24 Participants
Proximal artery treated Distal SFA	5 Participants n=12 Participants	3 Participants n=12 Participants	8 Participants n=24 Participants
Distal artery treated Proximal SFA	0 Participants n=12 Participants	3 Participants n=12 Participants	3 Participants n=24 Participants
Distal artery treated Middle SFA	0 Participants n=12 Participants	2 Participants n=12 Participants	2 Participants n=24 Participants
Distal artery treated Distal SFA	6 Participants n=12 Participants	3 Participants n=12 Participants	9 Participants n=24 Participants
Distal artery treated P1	2 Participants n=12 Participants	2 Participants n=12 Participants	4 Participants n=24 Participants
Distal artery treated P2	2 Participants n=12 Participants	1 Participants n=12 Participants	3 Participants n=24 Participants
Distal artery treated P3	2 Participants n=12 Participants	1 Participants n=12 Participants	3 Participants n=24 Participants
Runoff 1-vessel	4 Participants n=12 Participants	5 Participants n=12 Participants	9 Participants n=24 Participants
Runoff 2-vessel	6 Participants n=12 Participants	4 Participants n=12 Participants	10 Participants n=24 Participants
Runoff 3-vessel	2 Participants n=12 Participants	3 Participants n=12 Participants	5 Participants n=24 Participants
Platelet reactivity units (PRU)	117 units n=12 Participants • PRU was not measured in the control group	—	117 units n=24 Participants • PRU was not measured in the control group
Body mass Index	26 kg/m^2 n=12 Participants	27 kg/m^2 n=12 Participants	27 kg/m^2 n=24 Participants
Dialysis-Dependent	2 Participants n=12 Participants	0 Participants n=12 Participants	2 Participants n=24 Participants
Baseline antiplatelet use Clopidogrel	9 Participants n=12 Participants	11 Participants n=12 Participants	20 Participants n=24 Participants
Baseline antiplatelet use Aspirin	6 Participants n=12 Participants	11 Participants n=12 Participants	17 Participants n=24 Participants
Baseline antiplatelet use Ticagrelor	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: one year from intervention

Outcome measures

Outcome measures
Measure	Experimental: Screening/Treating for HPR n=12 Participants 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.	Control: Guideline Based Therapy n=12 Participants 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.
Proportion of Participants With Primary Patency	3 Participants	2 Participants

SECONDARY outcome

Timeframe: one year from intervention

Number of patients who underwent amputation on the lower extremity intervened on during study period.

Outcome measures

Outcome measures
Measure	Experimental: Screening/Treating for HPR n=12 Participants 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.	Control: Guideline Based Therapy n=12 Participants 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.
Amputation	0 Participants	2 Participants

SECONDARY outcome

Timeframe: one year from intervention

Any new stroke, myocardial infarction, death during study

Outcome measures

Outcome measures
Measure	Experimental: Screening/Treating for HPR n=12 Participants 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.	Control: Guideline Based Therapy n=12 Participants 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.
Major Adverse Cardiovascular Events	1 Participants	1 Participants

SECONDARY outcome

Timeframe: after study completion, 1 year

Correlation of HPR results between VerifyNow and CYP2C19 pharmacogenetics testing

Outcome measures

Outcome data not reported

Adverse Events

Experimental: Screening/Treating for HPR

Serious events: 6 serious events

Other events: 1 other events

Deaths: 1 deaths

Control: Guideline Based Therapy

Serious events: 7 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Screening/Treating for HPR n=17 participants at risk 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.	Control: Guideline Based Therapy n=14 participants at risk 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.
Blood and lymphatic system disorders Bleeding	11.8% 2/17 • Number of events 2 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.	7.1% 1/14 • Number of events 1 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure requiring hospitalization	11.8% 2/17 • Number of events 2 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.	28.6% 4/14 • Number of events 4 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.
Vascular disorders Acute limb ischemia	5.9% 1/17 • Number of events 1 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.	0.00% 0/14 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.
Infections and infestations Foot infection requiring hospitalization and return to operating room	11.8% 2/17 • Number of events 2 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.	21.4% 3/14 • Number of events 3 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.
Cardiac disorders NSTEMI	5.9% 1/17 • Number of events 1 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.	0.00% 0/14 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.
Nervous system disorders TIA	5.9% 1/17 • Number of events 1 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.	0.00% 0/14 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.

Other adverse events

Other adverse events
Measure	Experimental: Screening/Treating for HPR n=17 participants at risk 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.	Control: Guideline Based Therapy n=14 participants at risk 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.
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • Number of events 1 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.	0.00% 0/14 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.
Gastrointestinal disorders Diarrhea	5.9% 1/17 • Number of events 1 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.	0.00% 0/14 • 1 year Each adverse event is described, several patients had multiple adverse events thus the total of adverse events is larger than the number of patients affected by adverse events.

Additional Information

Marissa Jarosinski, MD

University of Pittsburgh

Phone: 9084005771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place