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)
Phase 3
Completed
- Conditions
- cardiovasculair overlijden, hartaanval en beroertemyocardial attackPAD (Peripheral artery disease)10003216
- Registration Number
- NL-OMON41255
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 225
Inclusion Criteria
1. Male and Female patients 50 years old or older
2. Symptomatic peripheral artery disease;For other inclusion criteria see protocol page 31.
Exclusion Criteria
1. Patients needing dual anti-platelet 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;For other exclusion criteria see protocol page 31-33.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time from randomisation to first occurrence of any event in the composite of CV<br /><br>death, MI, and ischaemic stroke.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Composite of CV death and MI, Ischaemic Stroke and Acute Limb Ischemia (ALI)<br /><br>requiring hospitalization.<br /><br>2. CV death.<br /><br>3. MI.<br /><br>4. all cause mortality.<br /><br>5. Composite of CV death and MI, all-cause Stroke (ischaemic or haemorrhagic)<br /><br>6. Acute Limb Ischemia (ALI) requiring hospitalization<br /><br>7. All lower Revascularization<br /><br>8. All revascularization procedures. </p><br>