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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Optical Coherence Tomography
Ticagrelor
Aspirin
Claudication
Clopidogrel
Lead sponsor: Arkansas Heart Hospital
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: University of Alabama at Birmingham
First posted: 2015-04-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the Intraluminal clot volume (in mm3)
timeFrame: At baseline and at 6 months
measure: Change in the Intraluminal clot length (mm)
timeFrame: At baseline and at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
Study officials:
affiliation: Arkansas Heart Hospital
name: Mehmet Cilingiroglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Massoud Leesar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Of Texas Health Science Center in San Antonio
name: Hinan Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Of Texas Health Science Center in San Antonio
name: Marc D Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arkansas Heart Hospital
name: Gerardo Rodriguez, MD PhD
role: STUDY_DIRECTOR
References: