Carotid Artery StenosisPhase 4SLICE-CEANCT04539223
A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy
A Phase 4 study testing Evolocumab in people with Carotid Artery Stenosis and Asymptomatic Carotid Artery Stenosis, run by Canadian Medical and Surgical Knowledge Translation Research Group at 3 sites in Canada.
Trial summary
This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Carotid Artery Stenosis, Asymptomatic Carotid Artery Stenosis
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 28 Aug 2020to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years old
- Significant (70-99%) carotid artery stenosis on one side, as measured by duplex ultrasound or angiogram
- Asymptomatic carotid stenosis (no history of ipsilateral stroke or TIA within 180 days)
- Deemed to be fit for carotid endarterectomy
- At least one of the following high-risk features: (a) prior stroke >6months prior to randomization; (b) peripheral artery disease; (c) current smoker; (d) type 2 diabetes; (e) eGFR ≥ 30 mL/min/1.73m2 and <60 ml/min/1.73m2; (f) hsCRP > 2mg/L in the absence of alternative known causes of hsCRP elevations including autoimmune diseases or active infections.
- On a moderate to high intensity statin therapy (defined as atorvastatin 40-80mg daily, rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, or another statin or non-statin therapy is clinically justified
Who cannot join
- Contraindications for MRI (pacemaker; neurostimulator; non-removable metal fragments in the eye; etc.)
- Patients in whom additional lowering of LDL-C with evolocumab is deemed to be clinically inappropriate
- Currently taking simvastatin >40mg/day
- High risk comorbidities such as severe heart failure, severe COPD, severe renal disease, known severe hepatic impairment, unstable coronary syndrome, and/or advanced dementia
- eGFR <30 mL/min/1.73m2
- Current, prior within past year, or known planned use of PCSK9 inhibition treatment
Show all 16Show fewer
- Known intolerance or allergy to evolocumab or other PCSK9 inhibitors
- Known latex allergy
- Women who are pregnant or breastfeeding
- Women of child bearing potential who are unwilling to use proper family planning or birth control methods to avoid pregnancy. Women are considered post-menopausal and not of childbearing potential after 12 months of natural (spontaneous) amenorrhea or have had a surgical procedure such as hysterectomy which makes pregnancy impossible
- Inability to comply with protocol-required study visits or procedures, including administration of study drug
- Severe concomitant disease that is expected to reduce life expectancy to less than 5 years
- Participation in another investigational device or drug study which is likely to affect the primary outcome, within 30 days of planned initiation of study drug
- Additional Inclusion Criteria
- If all eligibility criteria listed above are met, participants with only one high risk feature will undergo a time-of-flight MR angiogram, where one additional inclusion criteria will be assessed to confirm eligibility:
- 1. Evidence of IPH on MRI
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7
Mohammed Al-Omran, Mohammed.Al-Omran@unityhealth.to
Mohammed Al-Omran
- Recruiting
East Toronto Vascular Clinic
Toronto, Ontario, M4L3Y3
Leslie Summers deLuca, PhD, 416-480-6100 ext. 2593, leslie.summersdeluca@sunnybrook.ca
Ahmed Kayssi, MD
- Recruiting
St. Michael's Hospital
Toronto, Ontario
Sanjay Yagnik, 416 864 6060 ext. 2920, Sanjay.Yagnik@unityhealth.to
About this study
Official title: Study of Lipids Inside the Carotid With Evolocumab: A Randomized Trial of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy (SLICE-CEA CardioLink-8 Study)
This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.
- Being tested
- Evolocumab
- Keywords
- CEA, Carotid EndArterectomy, Evolocumab, Carotid Artery
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Autoinjector 1-mL deliverable volume of 140 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Drug (Evolocumab) | Active comparator | Individuals randomized to this arm will administer Evolocumab subcutaneously (SC) every two weeks (Q2W) for 26 weeks. Receives: Drug: Evolocumab |
| No Drug (Standard of Care) | No intervention | Individuals randomized to this arm will not administer a placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lipid rich necrotic core (LRNC) volume
As measured by MRI
Measured: Baseline to end of treatment (average of 6 months)
Secondary outcomes (2)
Change in vessel wall volume
As measured by MRI
Measured: Baseline to end of treatment (average of 6 months)
Change in vessel lumen volume
As measured by MRI
Measured: Baseline to end of treatment (average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start28 Aug 2020
- Primary completionApr 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies 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
- Twenty-six week treatment with or without evolocumab in addition to current medical management.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Medical and Surgical Knowledge Translation Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Mohammed Al-Omran, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539223
- Sponsor's protocol ID
- SLICE-CEA-001
- Acronym
- SLICE-CEA
- Status last verified
- Apr 2022
- First submitted
- 30 Aug 2020
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lipids Inside the Carotid With Evolocumab: A Randomized Trial of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy (SLICE-CEA CardioLink-8 Study)
- ClinicalTrials.gov ID
- NCT04539223
- Acronym / sponsor ID
- SLICE-CEA / SLICE-CEA-001
- Keywords
- CEA, Carotid EndArterectomy, Evolocumab, Carotid Artery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Canadian Medical and Surgical Knowledge Translation Research GroupUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 4 Sep 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.
This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Twenty-six week treatment with or without evolocumab in addition to current medical management.
| Arm | Type | Receives |
|---|---|---|
| Drug (Evolocumab) | Active comparator | Drug: EvolocumabIndividuals randomized to this arm will administer Evolocumab subcutaneously (SC) every two weeks (Q2W) for 26 weeks. |
| No Drug (Standard of Care) | No intervention | –Individuals randomized to this arm will not administer a placebo. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 40 years old
- Significant (70-99%) carotid artery stenosis on one side, as measured by duplex ultrasound or angiogram
- Asymptomatic carotid stenosis (no history of ipsilateral stroke or TIA within 180 days)
- Deemed to be fit for carotid endarterectomy
- At least one of the following high-risk features: (a) prior stroke >6months prior to randomization; (b) peripheral artery disease; (c) current smoker; (d) type 2 diabetes; (e) eGFR ≥ 30 mL/min/1.73m2 and <60 ml/min/1.73m2; (f) hsCRP > 2mg/L in the absence of alternative known causes of hsCRP elevations including autoimmune diseases or active infections.
Key exclusion criteria (16 listed)
- Contraindications for MRI (pacemaker; neurostimulator; non-removable metal fragments in the eye; etc.)
- Patients in whom additional lowering of LDL-C with evolocumab is deemed to be clinically inappropriate
- Currently taking simvastatin >40mg/day
- High risk comorbidities such as severe heart failure, severe COPD, severe renal disease, known severe hepatic impairment, unstable coronary syndrome, and/or advanced dementia
- eGFR <30 mL/min/1.73m2
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 |
|---|---|---|
| EvolocumabAutoinjector 1-mL deliverable volume of 140 mg/mL | Drug | Drug (Evolocumab) |
Primary outcome
Change in lipid rich necrotic core (LRNC) volume
Time frame: Baseline to end of treatment (average of 6 months)
As measured by MRI
2 secondary outcomes
Change in vessel wall volume
Time frame: Baseline to end of treatment (average of 6 months)
Change in vessel lumen volume
Time frame: Baseline to end of treatment (average of 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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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.
Mohammed Al-Omran, MD principal investigator
Unity Health Toronto
3 sites 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 in people with Carotid Artery Stenosis and Asymptomatic Carotid Artery Stenosis, run by Canadian Medical and Surgical Knowledge Translation Research Group at 3 sites in Canada.
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 6 inclusion and 16 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
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 Nicole Cooke ((416) 864-6060 ext. 43932, Nicole.Cooke@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lipid rich necrotic core (LRNC) volume (time frame: Baseline to end of treatment (average of 6 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 2 May 2022.