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

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-12
• Last Update Posted: 22 May 2017

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