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Trial record 1 of 1 for:    Examining Use of tiCagreLor In paD
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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
November 20, 2012
November 26, 2012
July 13, 2017
October 30, 2017
October 30, 2017
December 4, 2012
September 26, 2016   (Final data collection date for primary outcome measure)
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)
Time from randomization to first occurrence of any event in the composite of cardiovascular death, myocardial infarction and ischemic stroke [ Time Frame: Up to 37 months ]
Complete list of historical versions of study NCT01732822 on ClinicalTrials.gov Archive Site
  • 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)
  • Time from randomization to first occurrence of any event in the composite of cardiovascular death and myocardial infarction [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of cardiovascular death [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of myocardial infarction [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of all-cause mortality [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of composite of cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic) [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of any revascularisation [ Time Frame: Up to 37 months ]
  • 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)
Not Provided
 
A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease
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)
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.
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)
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Peripheral Artery Disease
  • Drug: Ticagrelor
    Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
    Other Name: Brilinta/Brilique
  • Drug: Clopidogrel
    Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
    Other Name: Plavix
  • Experimental: Ticagrelor
    Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
    Intervention: Drug: Ticagrelor
  • Active Comparator: Clopidogrel
    Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
    Intervention: Drug: Clopidogrel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13885
September 26, 2016
September 26, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Czechia,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
Czech Republic,   South Africa
 
NCT01732822
D5135C00001
2011-004616-36 ( EudraCT Number )
Yes
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Chair: William R Hiatt, MD University of Colorado School of Medicine
Study Director: Peter Held, MD AstraZeneca
AstraZeneca
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP