A study comparing cardiovascular effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease

Phase 1

• Conditions: peripheral artery disease; MedDRA version: 19.0Level: LLTClassification code 10067825Term: Peripheral arterial diseaseSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-004616-36-PL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-05
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13500

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>1. Composite of CV death, MI, Ischemic Stroke and Acute Limb Ischemia (ALI) requiring hospitalisation. <br>2. CV death <br>3. MI <br>4. All-cause mortality<br> 5. Composite of CV death, MI, and all cause stroke (ischaemic or haemorrhagic) <br>6. Acute Limb Ischemia requiring hospitalization <br>7. All lower extremity revascularization <br>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 Outcome Measures

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