Ticagrelor and 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.

Conditions

• Peripheral Arterial Disease

Interventions

PROCEDURE

Percutaneous Peripheral Intervention

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.

DEVICE

Optical Coherence Tomography

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.

OTHER

Ankle Brachial Index

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.

OTHER

Six minute walk distance

Assessment of the walking distance in 6 minutes.

DRUG

Aspirin

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.

DRUG

Aspirin + Ticagrelor

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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Arkansas Heart Hospital

  lead OTHER

Principal Investigators

• Mehmet Cilingiroglu, MD · Arkansas Heart Hospital

• Massoud Leesar, MD · University of Alabama at Birmingham

• Hinan Ahmed, MD · University Of Texas Health Science Center in San Antonio

• Marc D Feldman, MD · University Of Texas Health Science Center in San Antonio

• Gerardo Rodriguez, MD PhD · Arkansas Heart Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2017-01-17

Completion

2017-01-17

Countries

• United States

Study Locations