Vascular Medicine Clinical Trials

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The evaluation of the potential benefit and risk of any new behavioral (e.g., exercise, smoking cessation, nutrition), pharmacologic, biologic (angiogenic or cell therapy), or device is always best performed as a hypothesis-driven, prospective, randomized, multicenter clinical trial.

All central advances in cardiovascular medicine have been based on such prospective trials. Such trials can be difficult to design, should undergo peer review, are invariably associated with recruitment challenges, and data quality must be carefully monitored. When complete, they represent the gold standard of evidence development.

The Vascular Medicine Program has created and participated in vascular clinical trials since 1990. The CAPRIE study was the first to include a large cohort of individuals with PAD, and it was these PAD participants that directly led to FDA approval of clopidogrel. There once was a time, after the successful development of numerous effective anti-anginal drugs, that we wished for a comparably effective oral claudication medication. A series of prospective randomized trials demonstrated the impressive efficacy of cilostazol to improve claudication onset and peak walking time. Section staff participated in the trials, the FDA approval process and led the USA national cilostazol health professional educational initiatives. Since then, the pace of investigation has been sustained and it seems likely that PAD-specific treatments will continue to improve.

Selected Clinical Trials

Currently, the section has designed or is participating in the following prospective clinical trials:

PACE

PACE

The Cardiovascular Cell Therapy Research Network (CCTRN) is a network of physicians, scientists, and support staff dedicated to studying stem cell therapy for treating heart and vascular diseases. The goals of the Network are to complete research studies that will potentially lead to more effective treatments for patients with cardiovascular disease, and to share knowledge quickly with the healthcare community.

Dr. Hirsch, with Dr. Emerson Perin (Texas Heart Institute), serves as co-principal investigator for the “Patients with Intermittent Claudication Injected with ALDH Bright Cells (PACE) study. The purpose of this study is to determine the safety and effectiveness of bone marrow-derived stem cell therapy on improving tissue perfusion and/or peak walking time (PWT) in patients with peripheral arterial disease (PAD) and intermittent claudication.

For more information:

Cardiovascular Cell Therapy Research Network

NIH info for Peripheral Artery Disease

Info Video: PACE

PLX-PAD

PLX-PAD

Mesenchymal stromal cells are spindle-shaped cells that can be isolated from bone marrow, adipose tissue and other organs, including the placenta. When harvested from the placenta, these cells have been shown to improved blood flow and increase capillary density in animal models of PAD. The objective of the PLX-PAD study is to further establish the safety and efficacy of calf muscle PLX-PAD injections in subjects with peripheral artery disease and symptomatic claudication.

For more information:

Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)

EUCLID

EUCLID

Data from prior cardiovascular studies, such as PLATO, have compared the efficacy of ticagrelor to clopidogrel for the prevention of fatal and non-fatal cardiovascular (CV) events. Could this benefit be extended to individuals with PAD?

EUCLID is a global multicenter, randomized, double blind clinical trial. Subjects with established PAD are treated with either ticagrelor or clopidogrel monotherapy and followed for ischemic events for 18-36 months. This study will thus define the relative benefit of long-term treatment with ticagrelor vs. clopidogrel on the composite outcome cardiovascular death, myocardial infarction, and ischemic stroke in patients with established PAD.

For more information:

A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease (EUCLID)

VOYAGER

VOYAGER

The potential benefit of antithrombotic medications to improve outcomes in individuals with PAD has been incompletely investigated. The Vascular Outcomes studY of ASA alonG with rivaroxaban in Endovascular or surgical limb Revascularization for peripheral artery disease (VOYAGER PAD) study is an international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures

For more information:

Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities (VOYAGER PAD)

More info about our clinical trials:

If you are a physician or a patient interested in learning more about these trials, you may contact Mark Bakken.

Mark Bakken, RN
Cardiovascular Clinic: 612-365-5000
Direct Voicemail: 612-676-5844
Email: mbakken10@umphysicians.umn.edu

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