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SMT+APT+Vorapaxar for Peripheral Arterial Disease (XLPADTRACE Trial)

Phase 4
Waitlist Available
Research Sponsored by North Texas Veterans Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This is a Phase 4, randomized clinical trial to evaluate whether addition of Vorapaxar 2.08 mg daily vs. placebo daily on background antiplatelet therapy, prescribed for 6 months to patients with established peripheral artery disease (PAD) and Intermittent Claudication (IC) treated with standard medical therapy (SMT) would lead to an improvement in the peak walking time (PWT).

Eligible Conditions
  • Peripheral Arterial Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change from baseline to 6 months in the claudication onset time (COT) on GTT between participants enrolled in the test and control arms of the study.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SMT+APT+VorapaxarActive Control2 Interventions
Standard Medical Therapy (SMT): Presence of any two of the listed classes of agents \[angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), statin therapy and beta-blocker drugs\] + ability to perform at least 15 min of home walking a day, at least 3 times/week, at ≥20 steps/min Background Antiplatelet Therapy (APT) :At least one aspirin dose within 5 days prior to randomization at 325 mg dose in aspirin naïve patients (0-5 days of prior aspirin use) or at least one aspirin dose within 5 days prior to randomization at 81 mg dose in patients on chronic (\>5 days of prior use) aspirin therapy. Vorapaxar: Vorapaxar 2.08mg/day
Group II: SMT+APT+PlaceboPlacebo Group2 Interventions
Standard Medical Therapy (SMT): Presence of any two of the listed classes of agents \[angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), statin therapy and beta-blocker drugs\] + ability to perform at least 15 min of home walking a day, at least 3 times/week, at ≥20 steps/min Background Antiplatelet Therapy (APT) :At least one aspirin dose within 5 days prior to randomization at 325 mg dose in aspirin naïve patients (0-5 days of prior aspirin use) or at least one aspirin dose within 5 days prior to randomization at 81 mg dose in patients on chronic (\>5 days of prior use) aspirin therapy.

Find a Location

Who is running the clinical trial?

North Texas Veterans Healthcare SystemLead Sponsor
37 Previous Clinical Trials
4,005,029 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
119 Patients Enrolled for Peripheral Arterial Disease
~22 spots leftby Sep 2025
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