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

Phase 1

Conditions: Peripheral artery disease
MedDRA version: 14.1Level: LLTClassification code 10067825Term: Peripheral arterial diseaseSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-004616-36-ES

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 11500

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 4600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6900

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 and MI<br>2. CV death<br>3. MI<br>4. All-cause mortality<br>5. Composite of CV death, MI, and all cause stroke<br>6. All revascularisation;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 37 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Composite of cardiovascular death and myocardial infarction after randomization. <br>Cardiovascular death after randomization.<br>Myocardial infarction after randomization. <br>All-cause mortality after randomization.<br>Cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic) after randomization.<br>All revascularisation after randomization;Timepoint(s) of evaluation of this end point: Up to approximately 37 months