Clinical trial NCT02407314: Ticagrelor and Peripheral Arterial Disease
Official title: Impact of Ticagrelor and Aspirin Versus Clopidogrel and Aspirin in Patients With Claudication and Peripheral Arterial Disease (PAD): Thrombus Burden Assessed by Optical Coherence Tomography
Conditions: Peripheral Arterial Disease
Summary: This is an interventional study assessing the effectiveness of Ticagrelor on the reduction of thrombus burden using optical coherence tomography in patients undergoing peripheral artery stenting.
Interventions:
description: Percutaneous peripheral intervention is a common procedure performed by cardiologists to revascularize peripheral arterial lesions in patients (stent placement). This procedure is considered standard of care and is not experimental.
name: Percutaneous Peripheral Intervention
type: Procedure
description: This is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media. The device used is a cardiac catheter with OCT sensors on the tip of it. It will be used to assess the artery vessels after Percutaneous Peripheral Intervention.
name: Optical Coherence Tomography
type: Device
description: This a clinical assessment and consists of the calculation of the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.
name: Ankle Brachial Index
type: Other
description: Assessment of the walking distance in 6 minutes.
name: Six minute walk distance
type: Other
description: Aspirin, also known as acetylsalicylic acid [ASA], is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. Aspirin also has an antiplatelet effect by inhibiting the production of thromboxane, which under normal circumstances binds platelet molecules together to create a patch over damaged walls of blood vessels.
name: Aspirin
other_name: Acetylsalicylic acid [ASA]
type: Drug
description: This is a combination of drugs (Aspirin + Ticagrelor). Ticagrelor is a platelet aggregation inhibitor due to its properties as an antagonist of the P2Y12 receptor. Ticagrelor is a nucleoside analogue: the cyclopentane ring is similar to the sugar ribose, and the nitrogen rich aromatic ring system resembles the nucleobase purine, giving the molecule an overall similarity to adenosine.
name: Aspirin + Ticagrelor
other_name: acetylsalicylic acid [ASA] + Brillinta
type: Drug
Study arms:
design_group_description: Clopidogrel 75 mg + aspirin 81 mg for the first month followed by aspirin 81 mg alone for months 2-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT) ankle brachial index (ABI) and six minute walk distance.
design_group_title: Aspirin only
design_group_type: Sham Comparator
design_group_description: ticagrelor 90 mg bid + aspirin 81 mg for months 1-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT)ankle brachial index (ABI) and six minute walk distance.
design_group_title: Aspirin + Ticagrelor
design_group_type: Experimental
Sponsor: Medcath of Little Rock LLC
Collaborators: The University of Alabama at Birmingham
University of Texas Health Science Center At San Antonio
Drug name mappings:
name: 替格瑞洛
lang: CN
name: Ticagrelor
lang: EN
name: チカグレロル
lang: JP
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP