Critical Limb IschemiaPhase 4Evol-CLINCT04306471
Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI)
A Phase 4 study testing Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months. in people with Critical Limb Ischemia, run by Leonardo Clavijo at 1 site in United States.
Trial summary
Critical limb ischemia (CLI), is the most severe form of peripheral arterial disease (PAD), and clinically is characterized by pain at rest or non-healing ulcers of the lower extremities. Also, is associated with increased risk of cardiovascular death, myocardial infarction (MI), stroke and amputation. Feringa et al. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 4 Feb 2022
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age ≥40 to ≤85 years of age at the time of consent.
- Diagnosis CLI, Rutherford class IV to VI at the time of diagnosis, toe pressure ≤30 mmHg in non-diabetics or ≤40 mmHg in diabetics, angiography, duplex ultrasound or history of lower extremity surgical or endovascular revascularization for CLI.
- Stable on maximal tolerated dose of a statin, defined as the highest dose of statin (preferably atorvastatin or rosuvastatin) tolerated by the patient without side effects for at least one month.
Who cannot join
- Less than 1 month from last revascularization procedure including surgery or endovascular procedures.
- Subjects with active infection.
- Diabetes therapy with canagliflozin
- Subjects who in the opinion of the Principal Investigator will likely require additional. amputation or revascularization procedures during the duration of the study.
- Subjects with anticipated need of cardiac or surgical revascularization procedures.
- Subjects with chronic inflammatory conditions or requiring chronic systemic corticosteroids.
Show all 19Show fewer
- New York Heart Association (NYHA) class III or IV heart failure, or known left ventricular ejection fraction <30%.
- Uncontrolled arrhythmia.
- Uncontrolled hypertension with systolic BP>180 mmHg or diastolic >100 mmHg.
- Untreated thyroid disease.
- Severe chronic renal disease with estimated glomerular filtration rate (eGFR) <20 mL/min.
- Liver disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal.
- Status post-organ transplant.
- Pregnant and breastfeeding women.
- Fertile age female not on appropriate birth control.
- Clinically significant disease that, in the opinion of the Principal Investigator, is likely to require surgery or immunotherapy that may interfere with the completion of the study.
- Active cancer or life expectancy of less than two years.
- Chronic anticoagulation or hypercoagulability disorder.
- Atrial fibrillation with a CHADS-VASc Score ≥2 or any clinical condition which, in the opinion of the Principal Investigator increases the risk of cerebrovascular events.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90033
Jorge Caro, MPH, 323-382-7646, Jorge.Caro@med.usc.edu
Melissa Ramos, RN, 323-442-7983, Melissa.Ramos@med.usc.edu
About this study
Official title: Effect of Evolocumab in Patients With Critical Limb Ischemia
Critical limb ischemia (CLI), is the most severe form of peripheral arterial disease (PAD), and clinically is characterized by pain at rest or non-healing ulcers of the lower extremities. Also, is associated with increased risk of cardiovascular death, myocardial infarction (MI), stroke and amputation.
Feringa et al. demonstrated in a study of 1,374 patients with PAD that all cause and cardiac related mortality rates were lower in patients at higher statin dose and lower levels of low-density lipoprotein cholesterol (LDL).
Read more
Patients with CLI statin therapy and lower LDL levels improve amputation-free survival and patency after revascularization procedures.
In the FOURIER trial, LDL cholesterol reduction with the PCSK9 inhibitor evolocumab in patients with symptomatic PAD with or without prior myocardial infarction or stroke was associated with improved major adverse cardiac events (MACE) and major adverse limb events (MALE) at 2-years.
The effect of evolocumab in patients with CLI , after a recent arterial revascularization and active wounds is not known, also it is not known whether the cholesterol lowering effect of evolocumab in this group of patients is equivalent to that of non-CLI PAD patients and what the effect is on arterial perfusion, wound healing and other biological markers of vascular physiology.
This study aims to investigate the effect of evolocumab in patients with CLI on maximally tolerated lipid lowering therapy with a statin for one year after an index CLI event, requiring revascularization.
Read the detailed description
This is a double-blinded, prospective, randomized, pilot, study in thirty-two subjects with clinical CLI on background treatment with a statin. Subjects will be assessed based on their medical history and physical examination. Eligible subjects must meet all inclusion criteria and none of the exclusion criteria. There will be a treatment group and a placebo group, each with equal number of participants (n=16 patients in each group). After consent and enrollment, subjects will have a venous blood sample drawn to perform a lipid profile, serum vascular growth factors such as: vascular endothelial growth factor (VEGF), soluble VEGF receptor-1 (sVEGFR-1), soluble VEGF receptor-2 (sVEGFR-2), fibroblast growth factor (FGF), von Willebrand factor (vWF), tissue plasminogen activator (TPA) and plasminogen activator inhibitor -1 (PAI-1) and endothelial progenitor cells (EPCs). The investigators will then perform lower extremity arterial perfusion assessment of the affected and unaffected limb as rest ankle-brachial index (ABI), toe-brachial index (TBI), bilateral transcutaneous partial pressure of oxygen (TcPO2), spatial frequency domain imaging (SFDI), femoral studies (FMT, compliance, distensibility and stiffness), brachial endothelial function testing (FMD after hyperemia and maximal vasodilation). The study participant subjects will receive monthly subcutaneous injections of evolocumab 420 mg or placebo injections.
The LDL cholesterol will be measured at the baseline and a blinded measurement will also be performed at 3 and 12 months.
In patients with active wounds, healing will be evaluated at baseline and every month for six months by photographic analysis using planimetry and 2D/3D topographic analysis.
The study participants patients will be seen at 3, 6, and 9 months for follow up.
After 12 months +/- 2 weeks, all tests will be repeated.
- Conditions
- Critical Limb Ischemia
- Being tested
- Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months., Placebo 1 milliliter (mL) Injector Pen x 3 monthly for 12 months
- Keywords
- CLI, Gangrene, Ischemia, Amputation
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Gangrene, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months.Drug
Also called Repatha
The study subjects randomized to the treatment study arm will receive monthly subcutaneous injections of evolocumab 420 mg in the abdomen, thigh or upper arm. The study drug (evolocumab) prefilled injector pens are to be provided by Amgen.
Placebo 1 milliliter (mL) Injector Pen x 3 monthly for 12 monthsOther
Also called Control
The study subjects randomized to the control study arm will receive monthly subcutaneous injections of placebo 1 mL x 3 in the abdomen, thigh or upper arm. The study placebo prefilled injector pens are to be provided by Amgen.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | 16 Patients with Critical Limb Ischemia on maximum statin therapy will receive in addition the study intervention involving a monthly subcutaneous injection of evolocumab 420 mg for 12 months Receives: Drug: Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months. |
| Control arm | Placebo comparator | 16 Patients with Critical Limb Ischemia on maximum statin therapy will receive in addition a Placebo subcutaneous injection for 12 months. Receives: Other: Placebo 1 milliliter (mL) Injector Pen x 3 monthly for 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolocumab effect on LDL cholesterol changes in patients with Critical Limb Ischemia
To evaluate LDL cholesterol values in mg/dL in patients with Critical Limb Ischemia at baseline and after receiving three month therapy of Evolocumab compared to placebo.
The LDL cholesterol value changes will be measured as least-squares mean percentage
Measured: 3 months
Secondary outcomes (7)
Evolocumab effect on Lower extremity arterial perfusion changes on ankle-brachial indices (ABI).
To evaluate lower extremity arterial perfusion of the affected and unaffected limb in patients with CLI at baseline and after a 12 month therapy with evolocumab, measured by rate changes in ankle-brachial indices (ABI).
The ABI will be determined by the dorsalis pedis and posterior tibialis arteries highest systolic pressure value (in mmHg) of each foot divided by the brachial artery highest systolic pressure (in mmHg) of both arms.
Measured: 12 months
Evolocumab effect on Lower extremity arterial perfusion pressure changes on toe-brachial indices (TBI).
To evaluate lower extremity arterial perfusion of the affected and unaffected limb in patients with CLI at baseline and after a 12 month therapy with evolocumab, measured by rate changes in toe-brachial indices (TBI).
The TBI will be determined by the great toe pressure (in mmHg) of each foot divided by the brachial artery highest systolic pressure (in mmHg) of both arms.
Measured: 12 months
Evolocumab effect on Lower extremity microvascular perfusion changes.
To evaluate lower extremity microvascular perfusion of the affected and unaffected limb in patients with CLI at baseline and after a 12 month therapy with evolocumab compared with placebo, measured by tcpo2 mmHg changes in transcutaneous oxygen tension in the skin.
Transcutaneous oxygen will be performed by placing electrodes on the skin at different levels of each leg, foot and chest for reference.
Measured: 12 months
Evolocumab effect on foot perfusion changes.
To evaluate transcutaneous oxy-hemoglobin and deoxy-hemoglobin foot perfusion of the affected and unaffected foot in patients with CLI at baseline and after 6 month therapy with evolocumab compared with placebo, assessed by spatial frequency domain imaging (SFDI) mapping changes measured in percentage %.
Transcutaneous oxy-hemoglobin and deoxy-hemoglobin will be performed by obtaining SFDI images on the skin at different levels of each foot.
Measured: 6 months
Evolocumab effect on Femoral arterial distensibility changes.
To evaluate common femoral artery distensibility of the affected and unaffected limb in patients with CLI at baseline and after 12 month therapy with evolocumab compared with placebo, measured by the relative change in lumen area during systole for a given pressure change ( 10-3 x kPa-1).
Femoral distensibility will be performed by correlating systemic blood pressure and continuously recording by linear ultrasound using a LOGIQ eR7 ultrasound and a 12-L-RS linear array transducer and images analyzed by the QUIPU automated cardiovascular suite, carotid studio imaging software.
Measured: 12 months
Evolocumab effect on Femoral artery Medial Thickness (FMT) changes.
To evaluate common femoral artery medial thickness changes of the affected and unaffected limb in patients with CLI at baseline and after 12 month therapy with evolocumab compared with placebo.
The common femoral artery medial thickness will be measured in millimeters (mm) and performed by correlating systemic blood pressure and continuously recording by linear ultrasound using a LOGIQ eR7 ultrasound and a 12-L-RS linear array transducer and images analyzed by the QUIPU automated cardiovascular suite, carotid studio imaging software.
Measured: 12 months
Evolocumab effect on endothelial function by Flow Mediated Dilation (FMD) changes.
To evaluate brachial artery flow mediated dilation (brachial artery diameter in response to shear stress) of both arms in patients with CLI, at baseline and after 12 month therapy with evolocumab compared with placebo.
The FMD will be measured as the percentage (%) change in brachial artery diameter from baseline in response to the increase flow achieved after the inflation of a pneumatic cuff to supra-systolic pressure for 5 minutes The ultrasound brachial images will be acquired using a LOGIQ eR7 ultrasound and a 12-L-RS linear array transducer. Images will be analyzed by the QUIPU automated cardiovascular suite, FMD studio imaging software.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start24 Feb 2020
- Primary completion4 Feb 2021 (estimated)
- Study completion4 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Model description
- This is a double-blinded, prospective, randomized, pilot, study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leonardo Clavijo
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, Leonardo Clavijo, University of Southern California
- Investigators
- Leonardo Clavijo, MD, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306471
- Sponsor's protocol ID
- 20187090
- Other IDs
- HS-18-01010
- Acronym
- Evol-CLI
- Status last verified
- Mar 2020
- First submitted
- 21 Feb 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Evolocumab in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT04306471
- Acronym / sponsor ID
- Evol-CLI / 20187090
- Conditions
- Critical Limb Ischemia
- Keywords
- CLI, Gangrene, Ischemia, Amputation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Leonardo ClavijoUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 4 Feb 2021 (estimated)
- Study completion
- 4 Feb 2022 (estimated)
- First posted
- 13 Mar 2020 (actual)
- 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.
Critical limb ischemia (CLI), is the most severe form of peripheral arterial disease (PAD), and clinically is characterized by pain at rest or non-healing ulcers of the lower extremities. Also, is associated with increased risk of cardiovascular death, myocardial infarction (MI), stroke and amputation.
Feringa et al. demonstrated in a study of 1,374 patients with PAD that all cause and cardiac related mortality rates were lower in patients at higher statin dose and lower levels of low-density lipoprotein cholesterol (LDL).
Patients with CLI statin therapy and lower LDL levels improve amputation-free survival and patency after revascularization procedures.
In the FOURIER trial, LDL cholesterol reduction with the PCSK9 inhibitor evolocumab in patients with symptomatic PAD with or without prior myocardial infarction or stroke was associated with improved major adverse cardiac events (MACE) and major adverse limb events (MALE) at 2-years.
The effect of evolocumab in patients with CLI , after a recent arterial revascularization and active wounds is not known, also it is not known whether the cholesterol lowering effect of evolocumab in this group of patients is equivalent to that of non-CLI PAD patients and what the effect is on arterial perfusion, wound healing and other biological markers of vascular physiology.
This study aims to investigate the effect of evolocumab in patients with CLI on maximally tolerated lipid lowering therapy with a statin for one year after an index CLI event, requiring revascularization.
Detailed description
This is a double-blinded, prospective, randomized, pilot, study in thirty-two subjects with clinical CLI on background treatment with a statin. Subjects will be assessed based on their medical history and physical examination. Eligible subjects must meet all inclusion criteria and none of the exclusion criteria. There will be a treatment group and a placebo group, each with equal number of participants (n=16 patients in each group). After consent and enrollment, subjects will have a venous blood sample drawn to perform a lipid profile, serum vascular growth factors such as: vascular endothelial growth factor (VEGF), soluble VEGF receptor-1 (sVEGFR-1), soluble VEGF receptor-2 (sVEGFR-2), fibroblast growth factor (FGF), von Willebrand factor (vWF), tissue plasminogen activator (TPA) and plasminogen activator inhibitor -1 (PAI-1) and endothelial progenitor cells (EPCs). The investigators will then perform lower extremity arterial perfusion assessment of the affected and unaffected limb as rest ankle-brachial index (ABI), toe-brachial index (TBI), bilateral transcutaneous partial pressure of oxygen (TcPO2), spatial frequency domain imaging (SFDI), femoral studies (FMT, compliance, distensibility and stiffness), brachial endothelial function testing (FMD after hyperemia and maximal vasodilation). The study participant subjects will receive monthly subcutaneous injections of evolocumab 420 mg or placebo injections.
The LDL cholesterol will be measured at the baseline and a blinded measurement will also be performed at 3 and 12 months.
In patients with active wounds, healing will be evaluated at baseline and every month for six months by photographic analysis using planimetry and 2D/3D topographic analysis.
The study participants patients will be seen at 3, 6, and 9 months for follow up.
After 12 months +/- 2 weeks, all tests will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double-blinded, prospective, randomized, pilot, study
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months.16 Patients with Critical Limb Ischemia on maximum statin therapy will receive in addition the study intervention involving a monthly subcutaneous injection of evolocumab 420 mg for 12 months |
| Control arm | Placebo comparator | Other: Placebo 1 milliliter (mL) Injector Pen x 3 monthly for 12 months16 Patients with Critical Limb Ischemia on maximum statin therapy will receive in addition a Placebo subcutaneous injection for 12 months. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent.
- Age ≥40 to ≤85 years of age at the time of consent.
- Diagnosis CLI, Rutherford class IV to VI at the time of diagnosis, toe pressure ≤30 mmHg in non-diabetics or ≤40 mmHg in diabetics, angiography, duplex ultrasound or history of lower extremity surgical or endovascular revascularization for CLI.
- Stable on maximal tolerated dose of a statin, defined as the highest dose of statin (preferably atorvastatin or rosuvastatin) tolerated by the patient without side effects for at least one month.
Key exclusion criteria (19 listed)
- Less than 1 month from last revascularization procedure including surgery or endovascular procedures.
- Subjects with active infection.
- Diabetes therapy with canagliflozin
- Subjects who in the opinion of the Principal Investigator will likely require additional. amputation or revascularization procedures during the duration of the study.
- Subjects with anticipated need of cardiac or surgical revascularization procedures.
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 |
|---|---|---|
| Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months.Also: RepathaThe study subjects randomized to the treatment study arm will receive monthly subcutaneous injections of evolocumab 420 mg in the abdomen, thigh or upper arm. The study drug (evolocumab) prefilled injector pens are to be provided by Amgen. | Drug | Treatment arm |
| Placebo 1 milliliter (mL) Injector Pen x 3 monthly for 12 monthsAlso: ControlThe study subjects randomized to the control study arm will receive monthly subcutaneous injections of placebo 1 mL x 3 in the abdomen, thigh or upper arm. The study placebo prefilled injector pens are to be provided by Amgen. | Other | Control arm |
Primary outcome
Evolocumab effect on LDL cholesterol changes in patients with Critical Limb Ischemia
Time frame: 3 months
To evaluate LDL cholesterol values in mg/dL in patients with Critical Limb Ischemia at baseline and after receiving three month therapy of Evolocumab compared to placebo. The LDL cholesterol value changes will be measured as least-squares mean percentage
7 secondary outcomes
Evolocumab effect on Lower extremity arterial perfusion changes on ankle-brachial indices (ABI).
Time frame: 12 months
Evolocumab effect on Lower extremity arterial perfusion pressure changes on toe-brachial indices (TBI).
Time frame: 12 months
Evolocumab effect on Lower extremity microvascular perfusion changes.
Time frame: 12 months
Evolocumab effect on foot perfusion changes.
Time frame: 6 months
Evolocumab effect on Femoral arterial distensibility changes.
Time frame: 12 months
Evolocumab effect on Femoral artery Medial Thickness (FMT) changes.
Time frame: 12 months
Evolocumab effect on endothelial function by Flow Mediated Dilation (FMD) changes.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Leonardo Clavijo, MD, PhD principal investigator
University of Southern California
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 Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months. in people with Critical Limb Ischemia, run by Leonardo Clavijo 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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Caro, MPH (323-382-7646, Jorge.Caro@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolocumab effect on LDL cholesterol changes in patients with Critical Limb Ischemia (time frame: 3 months). 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 13 Mar 2020.