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

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ClinicalTrials.gov Identifier: NCT01732822
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Drug: Ticagrelor Drug: Clopidogrel Phase 3

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)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13885 participants
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)
Actual Study Start Date : December 4, 2012
Actual Primary Completion Date : September 26, 2016
Actual Study Completion Date : September 26, 2016

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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:
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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


  7. 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


  8. 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


  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 130 Years   (Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: William R Hiatt, MD University of Colorado School of Medicine
Study Director: Peter Held, MD AstraZeneca
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01732822    
Other Study ID Numbers: D5135C00001
2011-004616-36 ( EudraCT Number )
First Posted: November 26, 2012    Key Record Dates
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:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Clopidogrel
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