Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR - TI-PAD EVR

Exclusion Criteria

• 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• 2. Revascularisation planned only to treat proximal (inflow) disease in the iliac and/or common femoral arteries.
• 3. Previous randomisation in the present study.
• 4. Participation in another clinical study with an investigational product within the last 3 months or any new clinical trial during the course of this study.
• 5. Gangrene or ischemic ulcer of either lower extremity.
• 6. PAD of a non-atherosclerotic nature.
• 7. Clinical necessity to use dual antiplatelet therapy within 7 days prior to randomisation, or single anti-platelet therapy (ticlopidine, prasugrel, vorapaxar, ticagrelor or dipyridamole) other than clopidogrel or aspirin. Clopidogrel or aspirin can be taken up to and including the time that the loading dose is being given.
• 8. Clinical necessity to use the following restricted concomitant medications within 4 weeks prior to randomisation. Patients taking any of these medications at the Screening Visit may be considered for randomisation after a 4 week washout period from the medication.
• a. Pentoxifylline or cilostazol for relief of claudication symptoms
• b. Chronic oral or parenteral anticoagulant therapy (greater than 7 days)
• c. Strong inhibitors of CYP3A enzymes (Section 5.6.9.1)
• d. Strong inducers of CYP3A enzymes (Section 5.6.9.2)
• e. Simvastatin or lovastatin at daily doses over 40 mg
• 9. Any disease process (e.g. angina, cardiac abnormality, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), respiratory disease, obesity, stroke, severe neuropathy of the foot, symptomatic musculoskeletal disease of the lower extremity), other than PAD, that would interfere with exercise performance during the ETT or prevent the patient from reaching their claudication-limited PWT as the primary endpoint of the study.
• 10. Coronary, aortic surgery, angioplasty, lumbar sympathectomy or lower extremity surgery that impacts the ability to walk on a treadmill within the past 3 months prior to EVR. Revascularization of the non-index lower extremity within the past 4 weeks prior to EVR.
• 11. Any major lower limb amputation due to PAD anticipated within the next 3 months or prior major amputation due to PAD (minor toe amputations allowed if it does not interfere with ambulation).
• 12. Myocardial infarction or stroke in the previous 3 months.
• 13. Any concomitant disease process with a life expectancy of less than 1 year or which is sufficiently severe as to compromise the validity of test performance.
• 14. Dementia likely to jeopardise understanding of information pertinent to study conduct or compliance to study procedures.
• 15. Concern for the inability of the patient to comply with study procedures and/or followup (e.g., alcohol or drug abuse).
• 16. Resting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥95 mmHg at the Screening Visit, in spite of antihypertensive treatments allowed by the protocol.
• 17. A known bleeding diathesis, haemostatic or coagulation disorder, or systemic bleeding, whether resolved or ongoing.
• 18. Known severe liver disease (e.g., ascites and or clinical signs of coagulopathy).
• 19. Renal failure requiring dialysis.
• 20. History of previous intracranial bleed at any time, gastrointestinal bleed within the past 6 months, or major surgery within 30 days (if the surgical wound is judged to be associated with an increased risk of bleeding).
• 21. History of thrombocytopenia or neutropenia.
• 22. Hypersensitivity to ticagrelor, aspirin or lactose.
• 23. Initiation of antidiabetic, antihypertensive, lipid-lowering and beta-blocking drugs within 1 month prior to the Screening Visit.
• 24. Pregnancy, lactation, fertility without protection against pregnancy (for women of childbearing potential; a urine or serum pregnancy test will be performed at the Screening Visit).