NCT02975583

Vorapaxar and Lower Extremity Bypass Grafts

Withdrawn Phase 4 Last updated 25 January 2018

What this trial tests

Phase 4 trial testing Vorapaxar in Peripheral Artery Disease. Withdrawn.

Timeline

1 October 2017

Primary endpoint
10 January 2018

10 January 2018

Quick facts

Lead sponsor	Vanderbilt University
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Start date	1 October 2017
Primary completion	10 January 2018
Estimated completion	10 January 2018

Drugs / interventions tested

• Vorapaxar (VORAPAXAR) — full drug profile →
• Placebos — full drug profile →

Conditions studied

• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →

Sponsor

Vanderbilt University

Who can join

Adults 35 to 75, any sex, with Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There are no medical therapies indicated for reduction of limb ischemic events. Studies of dual-antiplatelet therapy with aspirin and clopidogrel versus aspirin alone (CASPAR) as well as studies of systemic anticoagulation (WAVE) have shown no benefit for either strategy in the reduction in limb vascular events. Surgical bypass grafting involves harvesting of the vein, warm ischemia with disruption of vaso vasorum, ischemia-reperfusion, and finally heightened hemodynamic stress in the new arterial environment. Vein grafts rapidly remodel in response to the increase in blood flow and pressure in an attempt to normalize them into physiological range. The investigators have previously identified 3 distinct temporal phases of the remodeling process: During the first 30 days following implantation is a critical period of luminal enlargement which appears to be an endothelium-independent process. The second phase occurs between 1 and 3 months and represents a period of stiffening of the vein graft indicating synthesis of fibrous proteins. The third period is referred to as biochemical remodeling wherein the vein recovers clinically measureable endothelial function. It is likely diabetes mellitus impacts each of these phases. TRA2°P-TIMI 50 demonstrated a reduction in acute limb ischemic (ALI) events (42% reduction) and urgent peripheral arterial revascularizations (35% reduction), a finding unique among medical therapies. While the temporal trend in reduction in ALI events occurred early and late after exposure suggestion an antithrombotic mechanism, the reduction in elective revascularization occurred later suggested beneficial effects beyond platelet inhibition. The purpose of this trial is to study the physiological impact of vorapaxar on lower extremity bypass graft maturation and function.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.