Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
- Conditions
- Peripheral Artery Disease (PAD)
- Interventions
- Drug: Comparator
- Registration Number
- NCT02227368
- Lead Sponsor
- AstraZeneca
- Brief Summary
To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have undergone endovascular revascularization for moderate to severe claudication or ischemic rest pain.
- Detailed Description
A Phase II Multicentre, Randomised, Double-Blind, Controlled, Parallel-Group Study to Evaluate the Walking Time Effect of Long-Term Ticagrelor in Comparison to Long-Term Aspirin Administration in Ambulatory Patients with Peripheral Artery Disease Undergoing Endovascular Revascularization - The Ticagrelor in Peripheral Artery Disease Endovascular Revascularization Study TI-PAD I EVR.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ticagrelor Ticagrelor 26 Weeks of ticagrelor 90mg twice a day plus aspirin placebo once daily Aspirin Comparator 26 Weeks of aspirin 100mg once daily plus ticagrelor placebo twice a day
- Primary Outcome Measures
Name Time Method Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET) 26 Weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET) 26 Weeks
Trial Locations
- Locations (1)
Research Site
🇺🇸San Antonio, Texas, United States