Peripheral Arterial DiseaseNCT03247972
Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease, run by Inova Health Care Services at 1 site in United States.
Trial summary
This investigation will be conducted in subjects >18 years of age with PAD. Platelet activation and aggregation, and biomarkers associated with platelet activation, oxidative stress, and inflammation will be assessed prior to initiation of study-HD statin therapy (baseline), after 8 weeks of high-dose statins and 24… 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?
- Evolocumab
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2017to 1 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Sixty patients with symptomatic PAD, as evidenced by: * either intermittent claudication with ABI <0.90, or * peripheral arterial revascularization procedure, or * amputation due to atherosclerotic disease.
Who may be able to join
None listed.
Who cannot join
- Prior use of any PCSK9 inhibition treatment Participation in any investigational study within the last 60 days.
- Severe renal dysfunction, defined as an eGFR <20 mL/min/1.73 m2 at screening
- Active liver disease or hepatic dysfunction, defined as AST or ALT >3 x ULN as determined by central laboratory analysis at screening
- Recipient of any major organ transplant (e.g., lung, liver, heart, bone marrow, renal)
- Known major active infection or major hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction in the judgment of the investigator
- Malignancy (except non-melanoma skin cancers, cervical in situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 10 years
Show all 13Show fewer
- Subject has received drugs via a systemic route that have known major interactions with background statin therapy within 1 month before randomization or is likely to require such treatment during the study period (e.g. cyclosporine, clarithromycin, HIV protease inhibitors, gemfibrozil)
- Female subject who is unwilling to use at least 2 effective birth control methods for at least 1 month before screening and 15 weeks after the end of treatment with investigational products, unless the subject is sterilized or postmenopausal.
- Subject is pregnant or breast feeding, or planning to become pregnant or to breastfeed during receipt of investigational products and within 15 weeks after the end of study treatment
- Known previous hypersensitivity reaction/s to the investigational products' active components and excipients.
- Subjects treated with any antithrombotic agents except aspirin.
- Subject likely to not be available to complete all protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge
- History or evidence of any other clinically significant disorder, condition, or disease other than those outlined above that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
This investigation will be conducted in subjects >18 years of age with PAD. Platelet activation and aggregation, and biomarkers associated with platelet activation, oxidative stress, and inflammation will be assessed prior to initiation of study-HD statin therapy (baseline), after 8 weeks of high-dose statins and 24 hours and 8 weeks after high dose statin + evolocumab therapy
Read the detailed description
Monoclonal antibodies against PCSK9 are innovative agents that provide very potent LDL reduction when administered on top of statins. PCSK9 antibodies prevent LDL receptor degradation and enhance circulatory LDL cholesterol clearance. High LDL is a major risk factor for PAD and therefore lipid-lowering therapy constitutes another important therapeutic intervention for patients with PAD. Evolocumab is a common PCSK-9 inhibitor that has been shown to reduce plasma LDL. In this study sixty subjects will be treated with high dose statins for 8 weeks followed by 8 weeks of high dose statin + evolocumab (420mg/4 wk) therapy to determine the effect of Repatha on markers of cholesterol, thrombosis, and inflammation.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Evolocumab
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Sixty subjects will be treated with high dose statins for 8 weeks followed by 8 weeks of high dose statin + evolocumab (420mg/4 wk) therapy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with peripheral artery disease receiving evolocumab + high dose statins | Adult patients with a history of Peripheral Artery Disease (PAD) defined as one or more of the following:
* Documented history of PAD
* Previous limb or foot amputation for arterial vascular disease (i.e., excludes trauma),
* Carotid artery disease (defined as >50% stenosis or prior revascularization ) Receives: Drug: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between ADP-induced % Maximum Platelet Aggregation Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Mean difference between 5uM ADP-induced % maximum platelet aggregation between V2 [after run-in period / 8 weeks of HD statin therapy] and V5 [end of study/ 8 weeks o]f continued HD statin therapy + evolocumab]
Measured: Change from week 8 (V2) to week 16 (V5)
Secondary outcomes (4)
Difference Between Collagen-induced Platelet Aggregation Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Mean difference between 4ug Collagen-induced platelet aggregation (%) between V2 [after run-in period / 8 weeks of HD statin therapy] and V5 [end of study/ 8 weeks of continued HD statin therapy + evolocumab]
Measured: Change from week 8 (v2) to week 16 (v5)
Difference Between SFFLRN-induced Platelet Aggregation Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Mean difference between SFFLRN-induced maximum platelet aggregation (%) between V2 [after run-in period / 8 weeks of HD statin therapy] and V5 [end of study/ 8 weeks of continued HD statin therapy + evolocumab]
Measured: Change from week 8 (v2) to week 16 (v5)
Difference Between Activated % P-selectin Positive Platelets Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Mean difference in activated % P-selectin positive platelets between V2 [after run-in period / 8 weeks of HD statin therapy] and V5 [end of study/ 8 weeks o]f continued HD statin therapy + evolocumab]
Measured: Change from week 8 (v2) to week 16 (v5)
Difference in TEG MAKH Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Mean difference TEG MAKH (platelet-fibrin clot strength) between V2 [after run-in period / 8 weeks of HD statin therapy] and V5 [end of study/ 8 weeks of continued HD statin therapy + evolocumab] Thromboelastography (TEG) is a viscoelastic hemostatic assay that measures the global viscoelastic properties of whole blood clot formation under low shear stress. TEG shows the interaction of platelets with the coagulation cascade (aggregation, clot strengthening, and fibrin cross-linking). MAKH is a measure of maximum platelet-fibrin clot strength. The normal range for MAKH is 53-68mm.
Measured: Change from week 8 (v2) to week 16 (v5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start11 Aug 2017
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Why it stopped: Research group transferred to another hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247972
- Sponsor's protocol ID
- 16-2584
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2017
- Last updated
- 16 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03247972
- Acronym / sponsor ID
- 16-2584
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Research group transferred to another hospital
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 16 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation will be conducted in subjects >18 years of age with PAD. Platelet activation and aggregation, and biomarkers associated with platelet activation, oxidative stress, and inflammation will be assessed prior to initiation of study-HD statin therapy (baseline), after 8 weeks of high-dose statins and 24 hours and 8 weeks after high dose statin + evolocumab therapy
Detailed description
Monoclonal antibodies against PCSK9 are innovative agents that provide very potent LDL reduction when administered on top of statins. PCSK9 antibodies prevent LDL receptor degradation and enhance circulatory LDL cholesterol clearance. High LDL is a major risk factor for PAD and therefore lipid-lowering therapy constitutes another important therapeutic intervention for patients with PAD. Evolocumab is a common PCSK-9 inhibitor that has been shown to reduce plasma LDL. In this study sixty subjects will be treated with high dose statins for 8 weeks followed by 8 weeks of high dose statin + evolocumab (420mg/4 wk) therapy to determine the effect of Repatha on markers of cholesterol, thrombosis, and inflammation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with peripheral artery disease receiving evolocumab + high dose statins | – | Drug: EvolocumabAdult patients with a history of Peripheral Artery Disease (PAD) defined as one or more of the following: * Documented history of PAD * Previous limb or foot amputation for arterial vascular disease (i.e., excludes trauma), * Carotid artery disease (defined as >50% stenosis or prior revascularization ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty patients with symptomatic PAD, as evidenced by: * either intermittent claudication with ABI <0.90, or * peripheral arterial revascularization procedure, or * amputation due to atherosclerotic disease.
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Prior use of any PCSK9 inhibition treatment Participation in any investigational study within the last 60 days.
- Severe renal dysfunction, defined as an eGFR <20 mL/min/1.73 m2 at screening
- Active liver disease or hepatic dysfunction, defined as AST or ALT >3 x ULN as determined by central laboratory analysis at screening
- Recipient of any major organ transplant (e.g., lung, liver, heart, bone marrow, renal)
- Known major active infection or major hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction in the judgment of the investigator
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 |
|---|---|---|
| EvolocumabSixty subjects will be treated with high dose statins for 8 weeks followed by 8 weeks of high dose statin + evolocumab (420mg/4 wk) therapy. | Drug | Patients with peripheral artery disease receiving evolocumab + high dose statins |
Primary outcome
Difference Between ADP-induced % Maximum Platelet Aggregation Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Time frame: Change from week 8 (V2) to week 16 (V5)
Mean difference between 5uM ADP-induced % maximum platelet aggregation between V2 [after run-in period / 8 weeks of HD statin therapy] and V5 [end of study/ 8 weeks o]f continued HD statin therapy + evolocumab]
4 secondary outcomes
Difference Between Collagen-induced Platelet Aggregation Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Time frame: Change from week 8 (v2) to week 16 (v5)
Difference Between SFFLRN-induced Platelet Aggregation Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Time frame: Change from week 8 (v2) to week 16 (v5)
Difference Between Activated % P-selectin Positive Platelets Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Time frame: Change from week 8 (v2) to week 16 (v5)
Difference in TEG MAKH Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab)
Time frame: Change from week 8 (v2) to week 16 (v5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Inova Health Care Services 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 0 inclusion and 13 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 16 Feb 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference Between ADP-induced % Maximum Platelet Aggregation Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab) (time frame: Change from week 8 (V2) to week 16 (V5)). 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 16 Feb 2024.