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Ticagrelor and Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Percutaneous Peripheral Intervention

Optical Coherence Tomography

Ankle Brachial Index

Six minute walk distance

Aspirin

Aspirin + Ticagrelor

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Optical Coherence Tomography, Ticagrelor, Aspirin, Claudication, Clopidogrel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arkansas Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Aspirin only

Aspirin + Ticagrelor

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in the Intraluminal clot volume (in mm3)

Intraluminal clot volume will be assessed by Optical Coherence Tomography using a Core Lab.

Change in the Intraluminal clot length (mm)

Intraluminal clotlength will be assessed by Optical Coherence Tomography using a Core Lab.

Secondary Outcome Measures

Full Information

NCT ID

NCT02407314

First Posted

March 18, 2015

Last Updated

January 9, 2019

Sponsor

Arkansas Heart Hospital

Collaborators

The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT02407314

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Terminated

Why Stopped

AZ discontinued study

Study Start Date

June 2015 (undefined)

Primary Completion Date

January 17, 2017 (Actual)

Study Completion Date

January 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arkansas Heart Hospital

Collaborators

The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease, Optical Coherence Tomography, Ticagrelor, Aspirin, Claudication, Clopidogrel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aspirin only

Arm Type

Sham Comparator

Arm Description

Arm Title

Aspirin + Ticagrelor

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Percutaneous Peripheral Intervention

Intervention 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.

Intervention Type

Device

Intervention Name(s)

Optical Coherence Tomography

Intervention 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.

Intervention Type

Other

Intervention Name(s)

Ankle Brachial Index

Intervention 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.

Intervention Type

Other

Intervention Name(s)

Six minute walk distance

Intervention Description

Assessment of the walking distance in 6 minutes.

Intervention Type

Drug

Intervention Name(s)

Aspirin

Other Intervention Name(s)

Acetylsalicylic acid [ASA]

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Aspirin + Ticagrelor

Other Intervention Name(s)

acetylsalicylic acid [ASA] + Brillinta

Intervention 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.

Primary Outcome Measure Information:

Title

Change in the Intraluminal clot volume (in mm3)

Description

Intraluminal clot volume will be assessed by Optical Coherence Tomography using a Core Lab.

Time Frame

At baseline and at 6 months

Title

Change in the Intraluminal clot length (mm)

Description

Intraluminal clotlength will be assessed by Optical Coherence Tomography using a Core Lab.

Time Frame

At baseline and at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: