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) - EUCLID

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004616-36-SK

Enrollment

13500

Registered

2012-09-19

Start date

2013-02-04

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peripheral artery disease MedDRA version: 18.1 Level: LLT Classification code 10067825 Term: Peripheral arterial disease System Organ Class: 100000004866

Interventions

Trade Name: BRILIQUE Product Name: Ticagrelor 90mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ticagrelor CAS Number: 274693-27-5 Current Sponsor code: AZD6140 Oth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and Female patients 50 years old or older 2. Symptomatic peripheral artery disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8100

Exclusion criteria

Exclusion criteria: 1. Patients needing dual anti-platlet drug treatment before start of study 2. Planned revascularisation or amputation 3. Patients with known bleeding disorders 4. Patients with a history of intracranial bleed 5. Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to compare the effect of long-term treatment with ticagrelor vs. clopidogrel on the event rate of the composite of CV death, MI and ischemic stroke in patients with established PAD. ;Secondary Objective: To compare the effect of long-term treatment with ticagrelor vs. clopidogrel in patients with established PAD 1. Composite of CV death, MI, Ischemic Stroke and Acute Limb Ischemia (ALI) requiring hospitalisation. 2. CV death 3. MI 4. All-cause mortality 5. Composite of CV death, MI, and all cause stroke (ischaemic or haemorrhagic) 6. Acute Limb Ischemia requiring hospitalization 7. All lower extremity revascularization 8. All revascularisation procedures;Primary end point(s): Any event after randomization from the composite of cardiovascular death, myocardial infarction and ischemic stroke;Timepoint(s) of evaluation of this end point: Up to approximately 40 months	—

Measure

Time frame

Main Objective: The primary objective of the study is to compare the effect of long-term treatment with ticagrelor vs. clopidogrel on the event rate of the composite of CV death, MI and ischemic stroke in patients with established PAD. ;Secondary Objective: To compare the effect of long-term treatment with ticagrelor vs. clopidogrel in patients with established PAD 1. Composite of CV death, MI, Ischemic Stroke and Acute Limb Ischemia (ALI) requiring hospitalisation. 2. CV death 3. MI 4. All-cause mortality 5. Composite of CV death, MI, and all cause stroke (ischaemic or haemorrhagic) 6. Acute Limb Ischemia requiring hospitalization 7. All lower extremity revascularization 8. All revascularisation procedures;Primary end point(s): Any event after randomization from the composite of cardiovascular death, myocardial infarction and ischemic stroke;Timepoint(s) of evaluation of this end point: Up to approximately 40 months

—

Secondary

Measure	Time frame
Secondary end point(s): Composite of cardiovascular death, myocardial infarction, ischaemic stroke and acute limb ischemia after randomization Cardiovascular death after randomization Myocardial infarction after randomization All-cause mortality after randomization Composite of cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic) after randomization Acute Limb Ischemia (ALI) requiring hospitalization after randomization All lower extremity revascularisation after randomization All revascularisation procedures after randomization.;Timepoint(s) of evaluation of this end point: Up to approximately 40 months	—

Measure

Time frame

Secondary end point(s): Composite of cardiovascular death, myocardial infarction, ischaemic stroke and acute limb ischemia after randomization Cardiovascular death after randomization Myocardial infarction after randomization All-cause mortality after randomization Composite of cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic) after randomization Acute Limb Ischemia (ALI) requiring hospitalization after randomization All lower extremity revascularisation after randomization All revascularisation procedures after randomization.;Timepoint(s) of evaluation of this end point: Up to approximately 40 months

—

Countries

Argentina, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, 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

Contacts

Public ContactInformation Centre

AstraZeneca

information.center@astrazeneca.com0018002369933

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026