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Completed

NCT Number: NCT01732822

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

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

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

50 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

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

Other names: Brilinta/Brilique

clopidogrel

Drug

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

Other names: Plavix

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: EUCLID

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2012
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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