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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01732822
• Date of registration: 20/11/2012
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease EUCLID
• Scientific 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)
• Date of first enrolment: December 4, 2012
• Target sample size: 13885
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01732822
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Czechia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam

Contacts

• Name: Peter Held, MD
• Affiliation: AstraZeneca

• Name: William R Hiatt, MD
• Affiliation: University of Colorado School of Medicine

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Artery Disease

Intervention(s)

Drug: Clopidogrel

Drug: Ticagrelor

Primary Outcome(s)

Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke [Time Frame: From randomization to PACD, an average of 2.5 years]

Secondary Outcome(s)

Lower Extremity Revascularization [Time Frame: From randomization to PACD, an average of 2.5 years]

MI [Time Frame: From randomization to PACD, an average of 2.5 years]

All-cause Mortality [Time Frame: From randomization to PACD, an average of 2.5 years]

Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic) [Time Frame: From randomization to PACD, an average of 2.5 years]

Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other]) [Time Frame: From randomization to PACD, an average of 2.5 years]

Composite of CV Death, MI, Ischemic Stroke, and ALI [Time Frame: From randomization to PACD, an average of 2.5 years]

CV Death [Time Frame: From randomization to PACD, an average of 2.5 years]

ALI [Time Frame: From randomization to PACD, an average of 2.5 years]

Secondary ID(s)

2011-004616-36

D5135C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/10/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01732822