Conditions: Peripheral Artery Disease (PAD)
Keywords: Myocardial Infarction Peripheral Arterial disease Mycardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Altherosclerosis Arteriosclerosis Arterial Occlusive Diseases Peripheral Vascular Diseases Ticagrelor Ticlopidine Platelet Aggregation inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinegic P2Y Receptor Antagonists Purinegic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Actions Physiological Effects of Drugs Fibrinolytic Agents Crardiovascular Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

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.

Arms:
arm 1: 26 Weeks of ticagrelor 90mg twice a day plus aspirin placebo once daily arm 2: 26 Weeks of aspirin 100mg once daily plus ticagrelor placebo twice a day

Interventions: intervention 1: Ticagrelor intervention 2: Comparator
Intervention descriptions: intervention 1: Antiplatelet therapy approved for ACS. Antagonist of P2Y12 and inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation. intervention 2: Aspirin monotherapy anti-platelet treatment for PAD patients following EVR procedures

Protocol document: