- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02407314
Ticagrelor and Peripheral Arterial Disease
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Arkansas Heart Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: 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.
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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.
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.
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.
Assessment of the walking distance in 6 minutes.
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.
Other Names:
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Experimental: 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.
|
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.
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.
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.
Assessment of the walking distance in 6 minutes.
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Intraluminal clot volume (in mm3)
Time Frame: At baseline and at 6 months
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Intraluminal clot volume will be assessed by Optical Coherence Tomography using a Core Lab.
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At baseline and at 6 months
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Change in the Intraluminal clot length (mm)
Time Frame: At baseline and at 6 months
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Intraluminal clotlength will be assessed by Optical Coherence Tomography using a Core Lab.
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At baseline and at 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Ticagrelor
Other Study ID Numbers
- ESR-14-10020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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