Overview

This trial is active, not recruiting.

Condition peripheral artery disease
Treatments ticagrelor, clopidogrel
Phase phase 3
Sponsor AstraZeneca
Start date December 2012
End date August 2016
Trial size 13500 participants
Trial identifier NCT01732822, 2011-004616-36, D5135C00001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
ticagrelor Brilinta/Brilique
Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
(Active Comparator)
Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
clopidogrel Plavix
Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets

Primary Outcomes

Measure
Time from randomization to first occurrence of any event in the composite of cardiovascular death, myocardial infarction and ischemic stroke
time frame: Up to 40 months

Secondary Outcomes

Measure
Time from randomisation to first occurrence of any event in the composite of CV death, MI, ischemic stroke and ALI
time frame: Up to 40 months
Time from randomization to occurrence of cardiovascular death
time frame: Up to 40 months
Time from randomization to occurrence of myocardial infarction
time frame: Up to 40 months
Time from randomization to occurrence of all-cause mortality
time frame: Up to 40 months
Time from randomization to occurrence of composite of cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic)
time frame: Up to 40 months
Time from randomisation to occurrence of ALI
time frame: Up to 40 months
Time from randomisation to occurrence of lower extremity revascularization
time frame: Up to 40 months
Time from randomisation to occurrence of any revascularisation (coronary, peripheral [limb, mesenteric, renal, carotid and other])
time frame: Up to 40 months

Eligibility Criteria

Male or female participants from 50 years up to 130 years old.

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

Additional Information

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)
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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.