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

NCT ID: NCT01732822

Last Updated: 2017-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

13885 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-04

Study Completion Date

2016-09-26

Brief Summary

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The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.

Detailed Description

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A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)

Conditions

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Peripheral Artery Disease

Keywords

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Peripheral artery disease Atherothrombotic events Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ticagrelor

Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets

Clopidogrel

Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets

Interventions

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Ticagrelor

Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets

Intervention Type DRUG

Clopidogrel

Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets

Intervention Type DRUG

Other Intervention Names

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Brilinta/Brilique Plavix

Eligibility Criteria

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Inclusion Criteria

* Male and Female patients 50 years old or older Symptomatic peripheral artery disease

Exclusion Criteria

* Patients needing dual anti-platlet drug treatment before start of study Planned revascularisation or amputation
* Patients with known bleeding disorders
* Patients with a history of intracranial bleed
* Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
Minimum Eligible Age

50 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William R Hiatt, MD

Role: STUDY_CHAIR

University of Colorado School of Medicine

Peter Held, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Manitowoc, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Wausau, Wisconsin, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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CABA, , Argentina

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CABA, , Argentina

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CABA, , Argentina

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Ciudadela, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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La Plata, , Argentina

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La Plata, , Argentina

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Mar del Plata, , Argentina

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Rosario, , Argentina

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Rosario, , Argentina

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Rosario, , Argentina

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Alexander City, Alabama, United States

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Rosario Santa Fe, , Argentina

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Auburn, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Mobile, Alabama, United States

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Mobile, Alabama, United States

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Cottonwood, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Fort Smith, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Berkeley, California, United States

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Beverly Hills, California, United States

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Chula Vista, California, United States

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El Cajon, California, United States

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Fresno, California, United States

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La Jolla, California, United States

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La Mesa, California, United States

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Laguna Hills, California, United States

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Long Beach, California, United States

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Mission Viejo, California, United States

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Moreno Valley, California, United States

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Northridge, California, United States

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Oceanside, California, United States

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Orange, California, United States

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Palo Alto, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Stockton, California, United States

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Torrance, California, United States

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Torrance, California, United States

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Loveland, Colorado, United States

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Bridgeport, Connecticut, United States

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Guilford, Connecticut, United States

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Norwalk, Connecticut, United States

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Stamford, Connecticut, United States

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Trumbull, Connecticut, United States

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Newark, Delaware, United States

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Newark, Delaware, United States

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Wilmington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Atlantis, Florida, United States

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Bradenton, Florida, United States

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Brandon, Florida, United States

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Brooksville, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Daytona Beach, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Hudson, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Orange Park, Florida, United States

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Palm Harbor, Florida, United States

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Pensacola, Florida, United States

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Plantation, Florida, United States

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Safety Harbor, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Stuart, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Trinity, Florida, United States

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Vero Beach, Florida, United States

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Wellington, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Cumming, Georgia, United States

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Lithonia, Georgia, United States

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Macon, Georgia, United States

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Martinez, Georgia, United States

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Savannah, Georgia, United States

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Tucker, Georgia, United States

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Idaho Falls, Idaho, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Hinsdale, Illinois, United States

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Rock Island, Illinois, United States

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Rockford, Illinois, United States

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Elkhart, Indiana, United States

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Fort Wayne, Indiana, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Merrillville, Indiana, United States

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Muncie, Indiana, United States

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Munster, Indiana, United States

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Valparaiso, Indiana, United States

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Iowa City, Iowa, United States

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West Des Moines, Iowa, United States

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Edgewood, Kentucky, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Alexandria, Louisiana, United States

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Baton Rouge, Louisiana, United States

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Bossier City, Louisiana, United States

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Shreveport, Louisiana, United States

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Auburn, Maine, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Greenbelt, Maryland, United States

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Fall River, Massachusetts, United States

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Haverhill, Massachusetts, United States

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Worcester, Massachusetts, United States

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Flint, Michigan, United States

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Flint, Michigan, United States

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Grand Rapids, Michigan, United States

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Kalamazoo, Michigan, United States

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Lansing, Michigan, United States

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Mount Clemens, Michigan, United States

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Muskegon, Michigan, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Biloxi, Mississippi, United States

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Jackson, Mississippi, United States

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Tupelo, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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North Las Vegas, Nevada, United States

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Belleville, New Jersey, United States

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Bridgewater, New Jersey, United States

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Camden, New Jersey, United States

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East Orange, New Jersey, United States

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Eatontown, New Jersey, United States

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Elmer, New Jersey, United States

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Flemington, New Jersey, United States

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Freehold, New Jersey, United States

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Hackensack, New Jersey, United States

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Haddon Heights, New Jersey, United States

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Linden, New Jersey, United States

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New Brunswick, New Jersey, United States

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Newark, New Jersey, United States

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Newark, New Jersey, United States

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Ocean City, New Jersey, United States

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Sewell, New Jersey, United States

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Summit, New Jersey, United States

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Voorhees Township, New Jersey, United States

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West Orange, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Hawthorne, New York, United States

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Johnson City, New York, United States

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Liverpool, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Saratoga Springs, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Troy, New York, United States

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Williamsville, New York, United States

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Yonkers, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Concord, North Carolina, United States

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Greensboro, North Carolina, United States

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High Point, North Carolina, United States

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Lenoir, North Carolina, United States

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Mooresville, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Fargo, North Dakota, United States

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Minot, North Dakota, United States

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Canton, Ohio, United States

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Centerville, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Springfield, Ohio, United States

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Toledo, Ohio, United States

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Youngstown, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Hillsboro, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Dunmore, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Newport, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Wormleysburg, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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York, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Easley, South Carolina, United States

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Greenville, South Carolina, United States

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Greenwood, South Carolina, United States

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Rapid City, South Dakota, United States

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Bristol, Tennessee, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Friendswood, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Hurst, Texas, United States

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Killeen, Texas, United States

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Lubbock, Texas, United States

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McAllen, Texas, United States

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McAllen, Texas, United States

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McKinney, Texas, United States

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North Richland Hills, Texas, United States

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Odessa, Texas, United States

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Round Rock, Texas, United States

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Tyler, Texas, United States

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Tyler, Texas, United States

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Victoria, Texas, United States

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Webster, Texas, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Falls Church, Virginia, United States

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Leesburg, Virginia, United States

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Lynchburg, Virginia, United States

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Manassas, Virginia, United States

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Midlothian, Virginia, United States

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Winchester, Virginia, United States

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Puyallup, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Charleston, West Virginia, United States

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South Charleston, West Virginia, United States

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Madison, Wisconsin, United States

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San Nicolás, , Argentina

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Santa Fe, , Argentina

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Belo Horizonte, , Brazil

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Belo Horizonte, , Brazil

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Belo Horizonte, , Brazil

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Belo Horizonte, , Brazil

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Brasília, , Brazil

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Campinas, , Brazil

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Campinas, , Brazil

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Canoas, , Brazil

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Curitiba, , Brazil

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Curitiba, , Brazil

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Juiz de Fora, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Rio de Janeiro, , Brazil

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Salvador, , Brazil

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Salvador, , Brazil

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Santo André, , Brazil

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São Bernardo do Campo, , Brazil

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São José do Rio Preto, , Brazil

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São José do Rio Preto, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Tatuí, , Brazil

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Uberlândia, , Brazil

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Burgas, , Bulgaria

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Gotse Delchev, , Bulgaria

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Haskovo, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Razlog, , Bulgaria

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Rousse, , Bulgaria

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Samokov, , Bulgaria

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Sandanski, , Bulgaria

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Sevlievo, , Bulgaria

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Sliven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Bridgewater, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Guelph, Ontario, Canada

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London, Ontario, Canada

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North York, Ontario, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Toronto, Ontario, Canada

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Brossard, Quebec, Canada

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Gatineau, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Chicoutimi, , Canada

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Concepción, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Talcahuano, , Chile

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Temuco, , Chile

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Temuco, , Chile

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Viña del Mar, , Chile

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Changsha, , China

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Changsha, , China

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Fuzhou, , China

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Haerbin, , China

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Hubei, , China

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Nanjing, , China

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Nanjing, , China

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Qingdao, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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References

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Hopley CW, Kavanagh S, Patel MR, Ostrom C, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Hiatt WR. Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial. Vasc Med. 2019 Oct;24(5):422-430. doi: 10.1177/1358863X19864172. Epub 2019 Jul 24.

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Hess CN, Huang Z, Patel MR, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Held P, Jones WS, Katona B, Mahaffey KW, Norgren L, Rockhold FW, Hiatt WR. Acute Limb Ischemia in Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):556-565. doi: 10.1161/CIRCULATIONAHA.119.039773. Epub 2019 Jun 26.

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Olivier CB, Mulder H, Hiatt WR, Jones WS, Fowkes FGR, Rockhold FW, Berger JS, Baumgartner I, Held P, Katona BG, Norgren L, Blomster J, Patel MR, Mahaffey KW. Incidence, Characteristics, and Outcomes of Myocardial Infarction in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. JAMA Cardiol. 2019 Jan 1;4(1):7-15. doi: 10.1001/jamacardio.2018.4171.

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Baumgartner I, Norgren L, Fowkes FGR, Mulder H, Patel MR, Berger JS, Jones WS, Rockhold FW, Katona BG, Mahaffey K, Hiatt WR; Executive Committee and Investigators of the EUCLID Trial. Cardiovascular Outcomes After Lower Extremity Endovascular or Surgical Revascularization: The EUCLID Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1563-1572. doi: 10.1016/j.jacc.2018.07.046.

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Norgren L, Patel MR, Hiatt WR, Wojdyla DM, Fowkes FGR, Baumgartner I, Mahaffey KW, Berger JS, Jones WS, Katona BG, Held P, Blomster JI, Rockhold FW, Bjorck M; EUCLID Steering Committee and Investigators. Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial. Eur J Vasc Endovasc Surg. 2018 Jan;55(1):109-117. doi: 10.1016/j.ejvs.2017.11.006. Epub 2017 Dec 20.

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Hiatt WR, Fowkes FG, Heizer G, Berger JS, Baumgartner I, Held P, Katona BG, Mahaffey KW, Norgren L, Jones WS, Blomster J, Millegard M, Reist C, Patel MR; EUCLID Trial Steering Committee and Investigators. Ticagrelor versus Clopidogrel in Symptomatic Peripheral Artery Disease. N Engl J Med. 2017 Jan 5;376(1):32-40. doi: 10.1056/NEJMoa1611688. Epub 2016 Nov 13.

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Jones WS, Baumgartner I, Hiatt WR, Heizer G, Conte MS, White CJ, Berger JS, Held P, Katona BG, Mahaffey KW, Norgren L, Blomster J, Millegard M, Reist C, Patel MR, Fowkes FG; International Steering Committee and Investigators of the EUCLID Trial. Ticagrelor Compared With Clopidogrel in Patients With Prior Lower Extremity Revascularization for Peripheral Artery Disease. Circulation. 2017 Jan 17;135(3):241-250. doi: 10.1161/CIRCULATIONAHA.116.025880. Epub 2016 Nov 13.

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Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.

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PMID: 27160944 (View on PubMed)

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-004616-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D5135C00001

Identifier Type: -

Identifier Source: org_study_id