NCT02407314

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2017

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

March 18, 2015

Last Update Submit

January 9, 2019

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial DiseaseOptical Coherence TomographyTicagrelorAspirinClaudicationClopidogrel

Outcome Measures

Primary Outcomes (2)

  • Change in the Intraluminal clot volume (in mm3)

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

    At baseline and at 6 months

  • Change in the Intraluminal clot length (mm)

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

    At baseline and at 6 months

Study Arms (2)

Aspirin only

SHAM COMPARATOR

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.

Procedure: Percutaneous Peripheral InterventionDevice: Optical Coherence TomographyOther: Ankle Brachial IndexOther: Six minute walk distanceDrug: Aspirin

Aspirin + Ticagrelor

EXPERIMENTAL

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.

Procedure: Percutaneous Peripheral InterventionDevice: Optical Coherence TomographyOther: Ankle Brachial IndexOther: Six minute walk distanceDrug: Aspirin + Ticagrelor

Interventions

Percutaneous Peripheral InterventionPROCEDURE

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.

Aspirin + TicagrelorAspirin only
Optical Coherence TomographyDEVICE

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.

Aspirin + TicagrelorAspirin only
Ankle Brachial IndexOTHER

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.

Aspirin + TicagrelorAspirin only
Six minute walk distanceOTHER

Assessment of the walking distance in 6 minutes.

Aspirin + TicagrelorAspirin only
AspirinDRUG

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.

Also known as: Acetylsalicylic acid [ASA]
Aspirin only
Aspirin + TicagrelorDRUG

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.

Also known as: acetylsalicylic acid [ASA] + Brillinta
Aspirin + Ticagrelor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Interventions

Tomography, Optical CoherenceAspirinTicagrelor

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative TechniquesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Mehmet Cilingiroglu, MD

    Arkansas Heart Hospital

    PRINCIPAL INVESTIGATOR

  • Massoud Leesar, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Hinan Ahmed, MD

    University Of Texas Health Science Center in San Antonio

    PRINCIPAL INVESTIGATOR

  • Marc D Feldman, MD

    University Of Texas Health Science Center in San Antonio

    PRINCIPAL INVESTIGATOR

  • Gerardo Rodriguez, MD PhD

    Arkansas Heart Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

April 2, 2015

Study Start

June 1, 2015

Primary Completion

January 17, 2017

Study Completion

January 17, 2017

Last Updated

January 11, 2019

Record last verified: 2019-01

Locations

US(1)