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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732822
First Posted: November 26, 2012
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.

Condition Intervention Phase
Peripheral Artery Disease Drug: Ticagrelor Drug: Clopidogrel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)


Secondary Outcome Measures:
  • Composite of CV Death, MI, Ischemic Stroke, and ALI [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

  • CV Death [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

  • MI [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

  • All-cause Mortality [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

  • Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic) [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

  • ALI [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

  • Lower Extremity Revascularization [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

  • Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other]) [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)


Other Outcome Measures:
  • Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding) [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

  • Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding) [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

  • Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding) [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

  • Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding) [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or Thrombolysis in Myocardial Infarction (TIMI) major bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

  • Non-CV Death [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with non-CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, CV death)

  • Changes in Fontaine Stage [ Time Frame: From randomization to PACD, an average of 2.5 years ]

    Progression of the clinical/symptomatic status of the limb by changes in Fontaine stage.

    Stage I - Asymptomatic Stage IIa - Intermittent claudication after more than 200 meters of pain free walking Stage IIb - Intermittent claudication after less than 200 meters of walking Stage III - Rest pain Stage IV - Ischemic ulcers or gangrene


  • Changes in Rutherford Classification [ Time Frame: From randomization to PACD, an average of 2.5 years ]

    Progression of the clinical/symptomatic status of the limb by changes in Rutherford classification.

    Category 0 - Asymptomatic Category 1 - Mild claudication Category 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Category 3 - Severe claudication Category 4 - Rest pain Category 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Category 6 - Severe ischemic ulcers or frank gangrene


  • Change in ABI/TBI From Baseline [ Time Frame: From randomization to PACD, an average of 2.5 years ]

    Change in ankle brachial index (ABI) / toe brachial index (TBI).

    Ankle brachial index (ABI) is the ratio of blood pressures from the ankle and arm and is used for diagnosing peripheral arterial occlusive disease (PAOD):

    Normal: 1 to 1.29 Borderline: 0.91 to 0.99 Mild PAOD: 0.71 to 0.90 Medium severe PAOD: 0.41 to 0.7 Severe PAOD: <0.4

    Toe brachial index (TBI) is the ratio between the toe pressure and the higher brachial pressure, used for diagnosing PAOD when the ABI cannot be used:

    Normal: >0.7 Mild: 0.5-0.7 Moderate: 0.35-0.5 Moderate-Severe: <0.35 and toe pressure 40 mmHg Severe: <0.35 and toe pressure < 30 mmHg


  • Any Amputation Caused by PAD [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with any amputation caused by peripheral arterial disease (PAD). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

  • Major Amputation Caused by PAD [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with major amputation caused by PAD. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

  • CV-related Hospitalization [ Time Frame: From randomization to PACD, an average of 2.5 years ]
    Participants with hospitalization associated with CV death, hospitalization due to MI, ischemic stroke, lower extremity revascularization, major amputation due to PAD, transient ischemic attack (TIA), coronary revascularization or unstable angina. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

  • TIMI Major Bleeding Events [ Time Frame: From the date of first dose and up to and including 7 days following the date of last dose of study drug ]
    Participants with TIMI major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

  • TIMI Major or Minor Bleeding Events [ Time Frame: From the date of first dose and up to and including 7 days following the date of last dose of study drug ]
    Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

  • PLATO Major Bleeding Events [ Time Frame: From the date of first dose and up to and including 7 days following the date of last dose of study drug ]
    Participants with PLATO major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

  • Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event [ Time Frame: From the date of first dose and up to and including 7 days following the date of last dose of study drug ]
    Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)


Enrollment: 13885
Actual Study Start Date: December 4, 2012
Study Completion Date: September 26, 2016
Primary Completion Date: September 26, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor
Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
Drug: Ticagrelor
Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
Other Name: Brilinta/Brilique
Active Comparator: Clopidogrel
Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
Drug: Clopidogrel
Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
Other Name: Plavix

Detailed Description:
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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732822


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Tyler, Texas, United States, 75708
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Victoria, Texas, United States, 77901
Research Site
Webster, Texas, United States, 77598
United States, Utah
Research Site
Ogden, Utah, United States, 84403
Research Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
Research Site
Charlottesville, Virginia, United States, 22908
Research Site
Falls Church, Virginia, United States, 22042
Research Site
Leesburg, Virginia, United States, 20176
Research Site
Lynchburg, Virginia, United States, 24501
Research Site
Manassas, Virginia, United States, 20109
Research Site
Midlothian, Virginia, United States, 23114
Research Site
Winchester, Virginia, United States, 22601
United States, Washington
Research Site
Puyallup, Washington, United States, 98372
Research Site
Spokane, Washington, United States, 99204
Research Site
Spokane, Washington, United States, 99210
Research Site
Tacoma, Washington, United States, 98405
United States, West Virginia
Research Site
Charleston, West Virginia, United States, 25304
Research Site
South Charleston, West Virginia, United States, 25309
United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 52713
Research Site
Manitowoc, Wisconsin, United States, 54220
Research Site
Milwaukee, Wisconsin, United States, 53215
Research Site
Wausau, Wisconsin, United States, 54401
Argentina
Research Site
Buenos aires, Argentina, 1078
Research Site
Buenos Aires, Argentina, C1425AGC
Research Site
Caba, Argentina, 1428
Research Site
Caba, Argentina, C1119ACN
Research Site
Caba, Argentina, C1179AAB
Research Site
Ciudadela, Argentina, 1702
Research Site
Cordoba, Argentina, 5000
Research Site
Cordoba, Argentina, X5000AAW
Research Site
Cordoba, Argentina, X5008HHW
Research Site
La Plata, Argentina, 1900
Research Site
La Plata, Argentina, B1902COS
Research Site
Mar del Plata, Argentina, B7600GNY
Research Site
Rosario Santa Fe, Argentina, S2000CVD
Research Site
Rosario, Argentina, 2000
Research Site
Rosario, Argentina, S2000CXP
Research Site
Rosario, Argentina, S2000DNM
Research Site
San Nicolás, Argentina, B2900DMH
Research Site
Santa Fe, Argentina, S3000FWO
Brazil
Research Site
Belo Horizonte, Brazil, 30110-100
Research Site
Belo Horizonte, Brazil, 30110070
Research Site
Belo Horizonte, Brazil, 30150-240
Research Site
Belo Horizonte, Brazil, 30190-130
Research Site
Brasilia, Brazil, 70710-905
Research Site
Campinas, Brazil, 13010-001
Research Site
Campinas, Brazil, 13060 904
Research Site
Canoas, Brazil, 92425-900
Research Site
Curitiba, Brazil, 80010-030
Research Site
Curitiba, Brazil, 80730-150
Research Site
Juiz de Fora, Brazil, 36010 570
Research Site
Porto Alegre, Brazil, 90035903
Research Site
Porto Alegre, Brazil, 90610-000
Research Site
Porto Alegre, Brazil, 90620-001
Research Site
Rio de Janeiro, Brazil, 20551-030
Research Site
Salvador, Brazil, 40140-110
Research Site
Salvador, Brazil, 41810-010
Research Site
Santo André, Brazil, 09060-650
Research Site
Sao Bernardo do Campo, Brazil, 09715090
Research Site
Sao Paulo, Brazil, 04039-000
Research Site
Sao Paulo, Brazil, 05017-00
Research Site
São José do Rio Preto, Brazil, 15015210
Research Site
São José do Rio Preto, Brazil, 15090-000
Research Site
Tatui, Brazil, 18270-170
Research Site
Uberlândia, Brazil, 38400-368
Bulgaria
Research Site
Burgas, Bulgaria, 8127
Research Site
Gotse Delchev, Bulgaria, 2900
Research Site
Haskovo, Bulgaria, 6300
Research Site
Pleven, Bulgaria, 5800
Research Site
Plovdiv, Bulgaria, 4000
Research Site
Razlog, Bulgaria, 2760
Research Site
Russe, Bulgaria, 7002
Research Site
Samokov, Bulgaria, 2000
Research Site
Sandanski, Bulgaria, 2800
Research Site
Sevlievo, Bulgaria, 5400
Research Site
Sliven, Bulgaria, 5000
Research Site
Sofia, Bulgaria, 1000
Research Site
Sofia, Bulgaria, 1142
Research Site
Sofia, Bulgaria, 1233
Research Site
Sofia, Bulgaria, 1309
Research Site
Sofia, Bulgaria, 1407
Research Site
Sofia, Bulgaria, 1606
Research Site
Sofia, Bulgaria, 1784
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada, A1A 3R5
Research Site
St. John's, Newfoundland and Labrador, Canada, A1C 5B8
Canada, Nova Scotia
Research Site
Bridgewater, Nova Scotia, Canada, B4V 3N2
Canada, Ontario
Research Site
Brampton, Ontario, Canada, L6Z 4N5
Research Site
Guelph, Ontario, Canada, N1H 1B1
Research Site
London, Ontario, Canada, N6A 5W9
Research Site
North York, Ontario, Canada, M3M 3E5
Research Site
Ottawa, Ontario, Canada, K1K 4L2
Research Site
Ottawa, Ontario, Canada, K1Y 4E9
Research Site
Smiths Falls, Ontario, Canada, K7A 4W8
Research Site
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Research Site
Brossard, Quebec, Canada, J4Z 2K9
Research Site
Gatineau, Quebec, Canada, J8Y 6S8
Research Site
Greenfield Park, Quebec, Canada, J4V 2G8
Research Site
Montreal, Quebec, Canada, H1M 1B1
Research Site
Montreal, Quebec, Canada, H1T 3Y7
Research Site
Montréal, Quebec, Canada, H1T 1C8
Research Site
Saint-Charles-Borromee, Quebec, Canada, J6E 6J2
Research Site
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Canada
Research Site
Chicoutimi, Canada, G7H 5H6
Research Site
Quebec, Canada, G1G 3Y8
Research Site
Quebec, Canada, G1L 3L5
Research Site
Quebec, Canada, G1N 4V3
Research Site
Quebec, Canada, G3K 2P8
Chile
Research Site
Concepcion, Chile, 4070060
Research Site
Santiago, Chile, 7500520
Research Site
Santiago, Chile, 7500710
Research Site
Santiago, Chile, 8207257
Research Site
Santiago, Chile, 8330024
Research Site
Santiago, Chile, 8380456
Research Site
Talcahuano, Chile, 4260000
Research Site
Temuco, Chile, 4781173
Research Site
Temuco, Chile, 4810371
Research Site
Vina del Mar, Chile, 2520997
China
Research Site
Beijing, China, 100029
Research Site
Beijing, China, 100038
Research Site
Beijing, China, 100191
Research Site
Beijing, China, 100853
Research Site
Changsha, China, 410008
Research Site
Changsha, China, 410013
Research Site
Fuzhou, China, 350025
Research Site
Haerbin, China, 150001
Research Site
Hubei, China, 430022
Research Site
Nanjing, China, 2100008
Research Site
Nanjing, China, 210029
Research Site
Qingdao, China, 266003
Research Site
Shanghai, China, 200000
Research Site
Shanghai, China, 200001
Research Site
Shanghai, China, 200032
Research Site
Shanghai, China, 200080
Research Site
Shanghai, China, 200127
Research Site
Shanghai, China, CN-200092
Research Site
Taiyuan, China, 030001
Research Site
Tianjin, China, 300121
Research Site
Tianjin, China, CN-300052
Research Site
Wuhan, China, 430022
Research Site
Wuxi, China, 214023
Research Site
Xi'an, China, 710061
Czechia
Research Site
Brno, Czechia, 602 00
Research Site
Brno, Czechia, 656 91
Research Site
Chomutov, Czechia, 430 02
Research Site
Hodonin, Czechia, 695 01
Research Site
Hradec Kralove, Czechia, 500 05
Research Site
Jindrichuv Hradec, Czechia, 377 01
Research Site
Kladno, Czechia, 272 59
Research Site
Liberec, Czechia, 460 63
Research Site
Olomouc, Czechia, 775 20
Research Site
Ostrava-Dubina, Czechia, 700 30
Research Site
Praha 10, Czechia, 101 00
Research Site
Praha 10, Czechia, 108 00
Research Site
Praha 1, Czechia, 110 00
Research Site
Praha 2, Czechia, 128 08
Research Site
Slany, Czechia, 274 01
France
Research Site
Amiens Cedex 1, France, 80054
Research Site
Bayonne, France, 64100
Research Site
Bordeaux Cedex, France, 33075
Research Site
Brest Cedex 2, France, 29609
Research Site
Caen, France, F-14033
Research Site
Castelnau-Le-Lez, France, F-34170
Research Site
Dijon, France, 21079
Research Site
La Tronche, France, 38700
Research Site
Le Chesnay Cedex, France, 78157
Research Site
Le Coudray Cedex, France, 28630
Research Site
Limoges, France, 87042
Research Site
MONTPELLIER Cedex 5, France, 34295
Research Site
Nantes Cedex 2, France, 44277
Research Site
Paris 14, France, 75674
Research Site
Paris Cedex 13, France, 75651
Research Site
PARIS Cedex 15, France, 75908
Research Site
PESSAC Cedex, France, 33604
Research Site
Rambouillet, France, 78120
Research Site
Saint-priest En Jarez, France, 42270
Research Site
Strasbourg Cedex, France, 67091
Research Site
Thionville, France, 57100
Research Site
Toulouse Cedex 3, France, 31076
Research Site
Toulouse Cedex 9, France, 31059
Research Site
Tours, France, 37044
Research Site
Vandoeuvre-Les-Nancy, France, 54511
Germany
Research Site
Berlin, Germany, 10713
Research Site
Berlin, Germany, 10787
Research Site
Berlin, Germany, 12203
Research Site
Dresden, Germany, 01099
Research Site
Dresden, Germany, 01219
Research Site
Dresden, Germany, 01307
Research Site
Dresden, Germany, 1067
Research Site
Erlangen, Germany, 91054
Research Site
Ettlingen, Germany, 76275
Research Site
Frankfurt am Main, Germany, 60590
Research Site
Hamburg, Germany, 20099
Research Site
Hamburg, Germany, 20246
Research Site
Hamburg, Germany, 22041
Research Site
Hamburg, Germany, 22559
Research Site
Heidelberg, Germany, 69120
Research Site
Kaiserslautern, Germany, 67657
Research Site
Leipzig, Germany, 04103
Research Site
Mainz, Germany, 55131
Research Site
Merseburg, Germany, 06217
Research Site
München, Germany, 80331
Research Site
München, Germany, 80336
Research Site
München, Germany, 80638
Research Site
Riesa, Germany, 01587
Research Site
Tübingen, Germany, 72076
Research Site
Wesel, Germany, 46483
Hungary
Research Site
Budapest, Hungary, 1106
Research Site
Budapest, Hungary, 1115
Research Site
Budapest, Hungary, 1122
Research Site
Budapest, Hungary, 1134
Research Site
Budapest, Hungary, 1212
Research Site
Debrecen, Hungary, 4025
Research Site
Debrecen, Hungary, 4032
Research Site
Eger, Hungary, 3300
Research Site
Gyula, Hungary, 5700
Research Site
Gyöngyös, Hungary, 3201
Research Site
Kaposvár, Hungary, 7400
Research Site
Kecskemét, Hungary, 6000
Research Site
Kistarcsa, Hungary, 2143
Research Site
Miskolc, Hungary, 3526
Research Site
Mosonmagyaróvár, Hungary, 9200
Research Site
Nyíregyháza, Hungary, 4400
Research Site
Pécs, Hungary, 7624
Research Site
Szeged, Hungary, 6721
Research Site
Szombathely, Hungary, 9700
Research Site
Székesfehérvár, Hungary, 8000
Research Site
Veszprém, Hungary, 8200
Italy
Research Site
Ancona, Italy, 60122
Research Site
Avellino, Italy, 83100
Research Site
Castelfranco Veneto, Italy, 31033
Research Site
Catania, Italy, 95100
Research Site
Catania, Italy, 95124
Research Site
Chieti, Italy, 66013
Research Site
Genova, Italy, 16132
Research Site
Lecce, Italy, 7310
Research Site
Milano, Italy, 20138
Research Site
Milano, Italy, 20162
Research Site
Napoli, Italy, 80100
Research Site
Napoli, Italy, 80131
Research Site
Oristano, Italy, 09170
Research Site
Padova, Italy, 35128
Research Site
Palermo, Italy, 90135
Research Site
Perugia, Italy, 06156
Research Site
Piacenza, Italy, 29100
Research Site
Pisa, Italy, 56124
Research Site
Ragusa, Italy, 97100
Research Site
Reggio Emilia, Italy, 42100
Research Site
Roma, Italy, 00161
Research Site
San Giovanni Rotondo, Italy, 71013
Research Site
Siena, Italy, 53100
Japan
Research Site
Asahi-shi, Japan, 289-2511
Research Site
Beppu-shi, Japan, 874-0011
Research Site
Fukuoka-shi, Japan, 810-0001
Research Site
Hamada-shi, Japan, 697-8511
Research Site
Himeji-shi, Japan, 671-1227
Research Site
Imabari-shi, Japan, 799-1592
Research Site
Itabashi-ku, Japan, 173-8610
Research Site
Kasuga-shi, Japan, 816-0864
Research Site
Kishiwada-shi, Japan, 596-8522
Research Site
Kobe-shi, Japan, 651-0053
Research Site
Koriyama-shi, Japan, 963-8052
Research Site
Kyoto-shi, Japan, 607-8062
Research Site
Matsubara-shi, Japan, 580-0032
Research Site
Matsuyama-shi, Japan, 790-8524
Research Site
Matsuyama-shi, Japan, 791-8026
Research Site
Meguro-ku, Japan, 152-8902
Research Site
Mito-shi, Japan, 310-0011
Research Site
Miura-gun, Japan, 240-0116
Research Site
Ogori-shi, Japan, 838-0141
Research Site
Oita-shi, Japan, 870-0192
Research Site
Sakaide-shi, Japan, 762-0007
Research Site
Sapporo-shi, Japan, 060-0031
Research Site
Sapporo-shi, Japan, 060-0033
Research Site
Sapporo-shi, Japan, 063-0005
Research Site
Sapporo-shi, Japan, 065-0027
Research Site
Shinjuku-ku, Japan, 162-8655
Research Site
Shizuoka-shi, Japan, 420-0853
Research Site
Suwa-shi, Japan, 392-8510
Research Site
Toyonaka-shi, Japan, 560-8565
Research Site
Tsu-shi, Japan, 514-8507
Research Site
Uji-shi, Japan, 611-0041
Research Site
Wakayama-shi, Japan, 640-8158
Research Site
Yamagata-shi, Japan, 990-8545
Research Site
Yatsushiro-shi, Japan, 866-8533
Research Site
Yokohama-shi, Japan, 231-0023
Research Site
Yokohama-shi, Japan, 234-8503
Research Site
Yokohama-shi, Japan, 236-0004
Research Site
Yokosuka-shi, Japan, 238-8567
Korea, Republic of
Research Site
Bucheon-si, Korea, Republic of, 14754
Research Site
Busan, Korea, Republic of, 49241
Research Site
Cheonan-si, Korea, Republic of, 330-715
Research Site
Daegu, Korea, Republic of, 700-712
Research Site
Daejeon, Korea, Republic of, 301-721
Research Site
Incheon, Korea, Republic of, 405-760
Research Site
Seongnam-si, Korea, Republic of, 13620
Research Site
Seoul, Korea, Republic of, 03722
Research Site
Seoul, Korea, Republic of, 05505
Research Site
Seoul, Korea, Republic of, 06591
Research Site
Seoul, Korea, Republic of, 08308
Research Site
Seoul, Korea, Republic of, 130-872
Research Site
Seoul, Korea, Republic of, 135-710
Research Site
Seoul, Korea, Republic of, 156-707
Mexico
Research Site
Aguascalientes, Mexico, 20230
Research Site
Chihuahua, Mexico, 31203
Research Site
Culiacan, Mexico, 80230
Research Site
Guadalajara, Mexico, 44670
Research Site
Guadalajara, Mexico, 44676
Research Site
Mexico, Mexico, 6700
Research Site
Monclova, Mexico, 25750
Research Site
Monterey, Mexico, 64060
Research Site
Monterrey, Mexico, 64060
Research Site
Monterrey, Mexico, 64460
Research Site
México, Mexico, 14000
Research Site
Queretaro, Mexico, 76000
Research Site
San Luis Potosi, Mexico, 78200
Research Site
San Luis Potosí, Mexico, 78240
Research Site
Tijuana, Mexico, 22014
Netherlands
Research Site
Amsterdam, Netherlands, 1066 EC
Research Site
Capelle Aan Den Ijssel, Netherlands, 2906 ZC
Research Site
Eindhoven, Netherlands, 5623 EJ
Research Site
Eindhoven, Netherlands, 5631 BM
Research Site
Groningen, Netherlands, 9713 GZ
Research Site
Heerlen, Netherlands, 6419 PC
Research Site
Leiden, Netherlands, 2333 ZA
Research Site
Nijmegen, Netherlands, 6532 SZ
Research Site
Rotterdam, Netherlands, 3045 PM
Research Site
Utrecht, Netherlands, 3584 CX
Philippines
Research Site
Cebu City, Philippines, 6000
Research Site
Cebu, Philippines, 6000
Research Site
Dasmarinas, Philippines, 4114
Research Site
Iloilo City, Philippines, 5000
Research Site
Lipa City, Philippines, 4217
Research Site
Makati, Philippines, 1229
Research Site
Mandaluyong City, Philippines, 1554
Research Site
Manila, Philippines, 1015
Research Site
Manila, Philippines, 2043
Research Site
Pasig City, Philippines, 1600
Research Site
Quezon City, Philippines, 1100
Research Site
Quezon City, Philippines, 1102
Research Site
Taguig City, Philippines, 1634
Research Site
Tanauan City, Philippines, 4232
Research Site
Vigan, Philippines, 2700
Poland
Research Site
Białystok, Poland, 15-111
Research Site
Bydgoszcz, Poland, 85-094
Research Site
Bydgoszcz, Poland, 85-231
Research Site
Gdynia, Poland, 81-157
Research Site
Gdynia, Poland, 81-402
Research Site
Gdynia, Poland, 81-423
Research Site
Gdynia, Poland, 81-472
Research Site
Grodzisk Mazowiecki, Poland, 05-825
Research Site
Katowice, Poland, 40-954
Research Site
Kraków, Poland, 30-529
Research Site
Kraków, Poland, 31-202
Research Site
Lublin, Poland, 20-044
Research Site
Ostrów Mazowiecka, Poland, 07-300
Research Site
Tarnów, Poland, 33-100
Research Site
Torun, Poland, 87-100
Research Site
Warszawa, Poland, 00-899
Research Site
Warszawa, Poland, 01-211
Research Site
Warszawa, Poland, 01-868
Research Site
Warszawa, Poland, 04-628
Research Site
Wrocław, Poland, 51-124
Research Site
Zamość, Poland, 22-400
Research Site
Łódź, Poland, 90-338
Research Site
Łódź, Poland, 94-238
Research Site
Łęczna, Poland, 21-010
Romania
Research Site
Bacau, Romania, 600114
Research Site
Braila, Romania, 810249
Research Site
Brasov, Romania, 500283
Research Site
Bucharest, Romania, 011461
Research Site
Bucharest, Romania, 011601
Research Site
Bucharest, Romania, 061118
Research Site
Buzau, Romania, 120203
Research Site
Cluj Napoca, Romania, 400001
Research Site
Craiova, Romania, 200147
Research Site
Craiova, Romania, 200642
Research Site
Iasi, Romania, 700304
Research Site
Pitesti, Romania, 110084
Research Site
Sibiu, Romania, 550245
Research Site
Sibiu, Romania, 550371
Research Site
Suceava, Romania, 720284
Research Site
Tg. Mures, Romania, 540124
Research Site
Timisoara, Romania, 300359
Russian Federation
Research Site
Arkhangelsk, Russian Federation, 163001
Research Site
Chelyabinsk, Russian Federation, 454021
Research Site
Ekaterinburg, Russian Federation, 620039
Research Site
Ekaterinburg, Russian Federation, 620149
Research Site
Gatchina, Russian Federation, 188300
Research Site
Kazan, Russian Federation, 420043
Research Site
Kazan, Russian Federation, 420101
Research Site
Moscow, Russian Federation, 117292
Research Site
Moscow, Russian Federation, 117630
Research Site
Moscow, Russian Federation, 127018
Research Site
Moscow, Russian Federation, 129090
Research Site
Nizhnii Novgorod, Russian Federation, 603018
Research Site
Novosibirsk, Russian Federation, 630055
Research Site
Perm, Russian Federation, 614000
Research Site
Perm, Russian Federation, 614107
Research Site
Perm, Russian Federation, 6144090
Research Site
Rostov-on-Don, Russian Federation, 344022
Research Site
Saint Petersburg, Russian Federation, 191015
Research Site
Saint Petersburg, Russian Federation, 195271
Research Site
Saint Petersburg, Russian Federation, 197022
Research Site
Saint Petersburg, Russian Federation, 197374
Research Site
Saint Petersburg, Russian Federation, 197706
Research Site
Saint Petersburg, Russian Federation, 198260
Research Site
Saint Petersburg, Russian Federation
Research Site
Saint-Petersburg, Russian Federation, 192242
Research Site
Saint-Petersburg, Russian Federation, 194354
Research Site
Saratov, Russian Federation, 410028
Research Site
Tomsk, Russian Federation, 234012
Research Site
Tomsk, Russian Federation, 634012
Research Site
Tver, Russian Federation, 170036
Research Site
Vladikavkaz, Russian Federation, 362007
Slovakia
Research Site
Dunajska Streda, Slovakia, 929 01
Research Site
Kosice, Slovakia, 040 01
Research Site
Nitra, Slovakia, 949 01
Research Site
Nove Zamky, Slovakia, 940 72
Research Site
Poprad, Slovakia, 058 49
Research Site
Presov, Slovakia, 080 01
Research Site
Trnava, Slovakia, 917 01
Research Site
Zilina, Slovakia, 010 01
Spain
Research Site
Albacete, Spain, 02006
Research Site
Alcorcón, Spain, 28922
Research Site
Alicante, Spain, 03010
Research Site
Badalona (Barcelona), Spain, 08916
Research Site
Badalona(Barcelona), Spain, 08916
Research Site
Barcelona, Spain, 08023
Research Site
Barcelona, Spain, 08025
Research Site
Boadilla del Monte, Spain, 28660
Research Site
Coruña, Spain, 15006
Research Site
Getafe, Spain, 29905
Research Site
Granada, Spain, 18012
Research Site
Hospitalet de Llobregat(Barcel, Spain, 08907
Research Site
Huelva, Spain, 21005
Research Site
Lérida, Spain, 25198
Research Site
Madrid, Spain, 28007
Research Site
Madrid, Spain, 28028
Research Site
Madrid, Spain, 28040
Research Site
Madrid, Spain, 28046
Research Site
Mallorca, Spain, 07120
Research Site
Manises, Spain, 46940
Research Site
Málaga, Spain, 29010
Research Site
Oviedo, Spain, 33006
Research Site
Sabadell, Spain, 08208
Research Site
Tarragona, Spain, 43005
Research Site
Toledo, Spain, 45004
Research Site
Valencia, Spain, 46014
Research Site
Valencia, Spain, 46026
Sweden
Research Site
Eksjö, Sweden, 575 81
Research Site
Gävle, Sweden, 801 87
Research Site
Göteborg, Sweden, 413 45
Research Site
Karlstad, Sweden, 651 85
Research Site
Malmö, Sweden, 205 02
Research Site
Stockholm, Sweden, 118 83
Research Site
Stockholm, Sweden, 171 76
Research Site
Uppsala, Sweden, 751 85
Research Site
Västerås, Sweden, 721 89
Research Site
Örebro, Sweden, 701 85
Thailand
Research Site
Bangkoknoi, Thailand, 10700
Research Site
Bangkok, Thailand, 10330
Research Site
Bangkok, Thailand, 10400
Research Site
Muang, Thailand, 40002
Research Site
Songkla, Thailand, 90110
Turkey
Research Site
Ankara, Turkey, 06100
Research Site
Ankara, Turkey, 06490
Research Site
Ankara, Turkey, 06800
Research Site
Bursa, Turkey, 16059
Research Site
Bursa, Turkey, 16330
Research Site
Istanbul, Turkey, 34096
Research Site
Istanbul, Turkey, 34303
Research Site
Istanbul, Turkey, 34668
Research Site
Istanbul, Turkey, 34846
Research Site
Izmir, Turkey, 35100
Research Site
Izmir, Turkey, 35360
Research Site
Malatya, Turkey, 44280
Ukraine
Research Site
Ivano-Frankivsk, Ukraine, 76000
Research Site
Ivano-Frankivsk, Ukraine, 76012
Research Site
Kharkiv, Ukraine, 61039
Research Site
Kharkiv, Ukraine, 61103
Research Site
Kharkiv, Ukraine, 61178
Research Site
Kyiv, Ukraine, 01601
Research Site
Kyiv, Ukraine, 02176
Research Site
Kyiv, Ukraine, 03000
Research Site
Odesa, Ukraine, 65025
Research Site
Uzhgorod, Ukraine, 88009
Research Site
Vinnytsia, Ukraine, 21018
Research Site
Zaporizhzhya, Ukraine, 69032
Research Site
Zaporizhzhya, Ukraine, 69104
Research Site
Zaporizhzhya, Ukraine, 69118
Research Site
Zaporizhzhya, Ukraine, 69600
United Kingdom
Research Site
Aberdeen, United Kingdom, AB25 2ZN
Research Site
Birmingham, United Kingdom, B91 2LJ
Research Site
Bournemouth, United Kingdom, BH7 7DW
Research Site
Cambridge, United Kingdom, CB2 0QQ
Research Site
Cheltenham, United Kingdom, GL53 7AN
Research Site
Dundee, United Kingdom, DD1 9SY
Research Site
Hull, United Kingdom, HU3 2JZ
Research Site
Leeds, United Kingdom, LS1 3EX
Research Site
Leicester, United Kingdom, LE1 5WW
Research Site
London, United Kingdom, SW17 0QT
Research Site
Newcastle upon TYNE, United Kingdom, NE7 7DN
Research Site
Worcester, United Kingdom, WR5 1DD
Vietnam
Research Site
Hanoi, Vietnam
Research Site
Hcmc, Vietnam
Research Site
Ho Chi Minh, Vietnam, 700000
Research Site
Ho Chi Minh, Vietnam
Research Site
Hochiminh, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: William R Hiatt, MD University of Colorado School of Medicine
Study Director: Peter Held, MD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01732822     History of Changes
Other Study ID Numbers: D5135C00001
2011-004616-36 ( EudraCT Number )
First Submitted: November 20, 2012
First Posted: November 26, 2012
Results First Submitted: July 13, 2017
Results First Posted: October 30, 2017
Last Update Posted: October 30, 2017
Last Verified: September 2017

Keywords provided by AstraZeneca:
Peripheral artery disease Atherothrombotic events Atherosclerosis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Clopidogrel
Ticlopidine
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors