Peripheral Arterial DiseasePhase 4NCT02407314
Ticagrelor and Peripheral Arterial Disease
A Phase 4 study testing Percutaneous Peripheral Intervention, Optical Coherence Tomography and Ankle Brachial Index in people with Peripheral Arterial Disease, run by Arkansas Heart Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Percutaneous Peripheral Intervention, Optical Coherence Tomography and Ankle Brachial Index
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 17 Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
About this study
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
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.
Read the 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
- Being tested
- Percutaneous Peripheral Intervention, Optical Coherence Tomography, Ankle Brachial Index, Six minute walk distance, Aspirin
- Keywords
- Peripheral Arterial Disease, Optical Coherence Tomography, Ticagrelor, Aspirin, Claudication, Clopidogrel
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Peripheral InterventionProcedure or surgery
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 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.
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.
Six minute walk distanceOther
Assessment of the walking distance in 6 minutes.
AspirinDrug
Also called Acetylsalicylic acid [ASA]
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 + TicagrelorDrug
Also called acetylsalicylic acid [ASA] + Brillinta
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Percutaneous Peripheral Intervention; Device: Optical Coherence Tomography; Other: Ankle Brachial Index; Other: Six minute walk distance; Drug: 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. Receives: Procedure: Percutaneous Peripheral Intervention; Device: Optical Coherence Tomography; Other: Ankle Brachial Index; Other: Six minute walk distance; Drug: Aspirin + Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Intraluminal clot volume (in mm3)
Intraluminal clot volume will be assessed by Optical Coherence Tomography using a Core Lab.
Measured: 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.
Measured: At baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
Why it stopped: AZ discontinued study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Mehmet Cilingiroglu, MD, Principal investigator, Arkansas Heart HospitalMassoud Leesar, MD, Principal investigator, University of Alabama at BirminghamHinan Ahmed, MD, Principal investigator, University Of Texas Health Science Center in San AntonioMarc D Feldman, MD, Principal investigator, University Of Texas Health Science Center in San AntonioGerardo Rodriguez, MD PhD, Study director, Arkansas Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407314
- Sponsor's protocol ID
- ESR-14-10020
- Status last verified
- Jan 2019
- First submitted
- 18 Mar 2015
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02407314
- Acronym / sponsor ID
- ESR-14-10020
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Optical Coherence Tomography, Ticagrelor, Aspirin, Claudication, Clopidogrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AZ discontinued study
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Arkansas Heart HospitalUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham
- Study start
- Jun 2015
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin only | Sham comparator | Procedure: Percutaneous Peripheral Intervention, Device: Optical Coherence Tomography, Other: Ankle Brachial Index, Other: Six minute walk distance, Drug: AspirinClopidogrel 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. |
| Aspirin + Ticagrelor | Experimental | Procedure: Percutaneous Peripheral Intervention, Device: Optical Coherence Tomography, Other: Ankle Brachial Index, Other: Six minute walk distance, Drug: Aspirin + Ticagrelorticagrelor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Peripheral InterventionPercutaneous 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. | Procedure or surgery | Aspirin + Ticagrelor, Aspirin only |
| Optical Coherence TomographyThis 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. | Device | Aspirin + Ticagrelor, Aspirin only |
| Ankle Brachial IndexThis 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. | Other | Aspirin + Ticagrelor, Aspirin only |
| Six minute walk distanceAssessment of the walking distance in 6 minutes. | Other | Aspirin + Ticagrelor, Aspirin only |
| AspirinAlso: Acetylsalicylic acid [ASA]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. | Drug | Aspirin only |
| Aspirin + TicagrelorAlso: acetylsalicylic acid [ASA] + BrillintaThis 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. | Drug | Aspirin + Ticagrelor |
Primary outcome
Change in the Intraluminal clot volume (in mm3)
Time frame: At baseline and at 6 months
Intraluminal clot volume will be assessed by Optical Coherence Tomography using a Core Lab.
Change in the Intraluminal clot length (mm)
Time frame: At baseline and at 6 months
Intraluminal clotlength will be assessed by Optical Coherence Tomography using a Core Lab.
Results and safety
The study was stopped early (reason given: AZ discontinued study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Cilingiroglu, MD principal investigator
Arkansas Heart Hospital
Massoud Leesar, MD principal investigator
University of Alabama at Birmingham
Hinan Ahmed, MD principal investigator
University Of Texas Health Science Center in San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous Peripheral Intervention, Optical Coherence Tomography and Ankle Brachial Index in people with Peripheral Arterial Disease, run by Arkansas Heart Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: AZ discontinued study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Intraluminal clot volume (in mm3) (time frame: At baseline and at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.