Ticagrelor and Peripheral Arterial Disease

NCT ID: NCT02407314

Last Updated: 2019-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-01-17

Brief 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.

Detailed Description

Prospective, randomized study, comparing ticagrelor + aspirin vs. aspirin monotherapy following the 4-week post-procedural combination of Ticagrelor or Plavix with low dose aspirin. The investigators will enroll a minimum of 40 patients. Patients will be enrolled if they have either claudication and/or critical limb ischemia, and angiographically identified superficial femoral artery (SFA) disease requiring intervention, with either total occlusion or a significant SFA stenosis with the presence of Optical Coherence Tomography (OCT) defined clot following stent placement.

Participants will be evaluated at baseline, 1 month, 4 months, 6 and 7 months following SFA intervention. At baseline demographic data will be collected, and anthropomorphic and physiological variables (body mass index, waist circumference, blood pressure). Baseline and 6-month ankle brachial index (ABI) will be performed. A 6-min walk test will be performed at baseline and 6-month follow-up. At 6 month time point patients in both treatment groups will return for a peripheral angiogram and repeat OCT imaging of the SFA segments of interest. Subject will have a final follow up clinic visit at 7 months.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspirin only

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.

Group Type: SHAM_COMPARATOR

Percutaneous Peripheral Intervention

Intervention Type: PROCEDURE

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.

Optical Coherence Tomography

Intervention Type: DEVICE

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.

Ankle Brachial Index

Intervention Type: OTHER

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.

Six minute walk distance

Intervention Type: OTHER

Assessment of the walking distance in 6 minutes.

Aspirin

Intervention Type: DRUG

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.

Aspirin + Ticagrelor

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.

Group Type: EXPERIMENTAL

Percutaneous Peripheral Intervention

Intervention Type: PROCEDURE

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.

Optical Coherence Tomography

Intervention Type: DEVICE

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.

Ankle Brachial Index

Intervention Type: OTHER

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.

Six minute walk distance

Intervention Type: OTHER

Assessment of the walking distance in 6 minutes.

Aspirin + Ticagrelor

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Six minute walk distance

Assessment of the walking distance in 6 minutes.

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Acetylsalicylic acid [ASA]; acetylsalicylic acid [ASA] + Brillinta

Eligibility Criteria

Inclusion Criteria

• Patients with lower extremity claudication and PAD due to significant SFA stenosis (>60%) or total occlusions (Rutherford 2-6) that affects the quality of life despite medical therapy.
• The presence of OCT identified clot in the Superficial Femoral Artery (SFA) following stent placement.
• Evidence of significant SFA disease involving the most symptomatic limb established by noninvasive vascular testing (ankle-brachial index [ABI] <0.9, toe brachial Index [TBI] of <0.6. If ABI>1.4, SFA systolic acceleration time >140 milliseconds); computed tomographic angiography, or magnetic resonance angiography confirming at least a 60% stenosis of the SFA.
• At least one non-treated Below The Knee (BTK) vessel patent
• Male and female outpatients 18 years of age.
• The only following devices may be used for the revascularization procedures: conventional balloons and bare metal stents (block randomization).
• Subject has been advised of the beneficial effects of smoking cessation and regular exercise but must not be in the process of changing their smoking status at the time of screening. Patients may resume or increase exercising as an effect of post procedurally improved lower limb perfusion.
• Peak Walking Time (PWT) limited only by claudication.
• Willingness to participate, documented by written informed consent.

Exclusion Criteria

• Patients requiring dual anti-platelet drug treatment before start of study
• Planned amputation
• Use of atherectomy devices
• Hypersensitivity to acetylsalicylic acid, or ticagrelor. For ticagrelor, hypersensitivity reactions in the past include angioedema
• Patients with known bleeding disorders
• Patients with known active pathological bleeding
• Patients needing chronic oral anticoagulant maintenance therapy
• Patients with a history of intracranial hemorrhage at any time, GI bleed in the past 6 months, or major surgery within the past 30 days
• Ischemic stroke during the past 3 months
• Patients considered to be at risk of bradycardic events unless treated with a permanent pacemaker
• Target is a restenotic lesion or in-stent restenosis
• Any scheduled revascularization procedure requiring dual-anti-platelet therapy for more than one month
• Severe hypertension that may put the patient at risk, systolic greater than or equal to 180 and/or diastolic greater than or equal to 100
• Severe liver disease
• History of congestive heart failure with an Left Ventricular Ejection Fraction (LVEF) of less than 30%
• Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)
• Infra-popliteal disease involving the last remaining vessel (single run-off)
• Prior lower extremity revascularization within the past 30 days prior to enrollment
• Atherectomy of PAD
• EXCIPIENTS to ticagrelor hypersensitivity
• Known pregnancy, breast-feeding, or intend to become pregnant during the study period (all female patients 55 years and younger, without past history of hysterectomy must have a pregnancy test prior to peripheral intervention at baseline and at 6 months)
• Creatinine clearance < 30 mL/min

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Arkansas Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehmet Cilingiroglu, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Heart Hospital

Massoud Leesar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Hinan Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

University Of Texas Health Science Center in San Antonio

Marc D Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

University Of Texas Health Science Center in San Antonio

Gerardo Rodriguez, MD PhD

Role: STUDY_DIRECTOR

Arkansas Heart Hospital

Locations

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

ESR-14-10020

Identifier Type: -

Identifier Source: org_study_id