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

Completed

Phase 3 Results

Trial Description

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

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)

Conditions

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
    ARM 1: Kind: Experimental
    Label: Clopidogrel
  • Ticagrelor Drug
    Intervention Desc: Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
    ARM 1: Kind: Experimental
    Label: Ticagrelor

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Time from randomization to first occurrence of any event in the composite of cardiovascular death, myocardial infarction and ischemic stroke Up to 37 months No
Secondary Time from randomization to first occurrence of any event in the composite of cardiovascular death and myocardial infarction Up to 37 months No
Secondary Time from randomization to occurrence of cardiovascular death Up to 37 months No
Secondary Time from randomization to occurrence of myocardial infarction Up to 37 months No
Secondary Time from randomization to occurrence of all-cause mortality Up to 37 months No
Secondary Time from randomization to occurrence of composite of cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic) Up to 37 months No
Secondary Time from randomization to occurrence of any revascularisation Up to 37 months No
Secondary Time from randomisation to first occurrence of any event in the composite of CV death, MI, ischemic stroke and ALI Up to 40 months No
Secondary Time from randomisation to occurrence of ALI Up to 40 months No
Secondary Time from randomisation to occurrence of lower extremity revascularization Up to 40 months No
Secondary Time from randomisation to occurrence of any revascularisation (coronary, peripheral [limb, mesenteric, renal, carotid and other]) Up to 40 months No
Primary Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke From randomization to PACD, an average of 2.5 years
Secondary Composite of CV Death, MI, Ischemic Stroke, and ALI From randomization to PACD, an average of 2.5 years
Secondary CV Death From randomization to PACD, an average of 2.5 years
Secondary MI From randomization to PACD, an average of 2.5 years
Secondary All-cause Mortality From randomization to PACD, an average of 2.5 years
Secondary Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic) From randomization to PACD, an average of 2.5 years
Secondary ALI From randomization to PACD, an average of 2.5 years
Secondary Lower Extremity Revascularization From randomization to PACD, an average of 2.5 years
Secondary Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other]) From randomization to PACD, an average of 2.5 years

Sponsors