Phase 3
N=13,885
A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease
Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01732822 ↗Enrolled (actual)
13,885
Serious AEs
25.3%
Results posted
Oct 2017
Primary outcome: Primary: Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke — 751; 740 Participants — p=0.650
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ticagrelor (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke |
751; 740 | 0.650 |
| SECONDARY Composite of CV Death, MI, Ischemic Stroke, and ALI |
839; 833 | 0.738 |
| SECONDARY CV Death |
363; 343 | 0.400 |
| SECONDARY MI |
349; 334 | 0.482 |
| SECONDARY All-cause Mortality |
628; 635 | 0.913 |
| SECONDARY Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic) |
766; 759 | 0.724 |
| SECONDARY ALI |
117; 115 | 0.846 |
| SECONDARY Lower Extremity Revascularization |
846; 892 | 0.298 |
| SECONDARY Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other]) |
1211; 1250 | 0.462 |
Summary
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01732822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.