Lipid Lowering, Vascular InflammationPhase 4NCT02941016
Vascular Inflammation and Cholesterol Lowering Therapy
A Phase 4 study testing Evolocumab or Alirocumab in people with Lipid Lowering, Vascular Inflammation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study aim to detect change in vascular inflammation following intense lipid lowering therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipid Lowering, Vascular Inflammation
- What is being tested?
- Evolocumab or Alirocumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to 1 Oct 2020
- 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
- treatment with PCSK-9 inhibitors
Who cannot join
- Infection Pregnancy Severe claustrophobia Weight >140 kg
Trial locations and contacts
1 site in 1 country.
About this study
This study aim to detect change in vascular inflammation following intense lipid lowering therapy
- Conditions
- Lipid Lowering, Vascular Inflammation
- Being tested
- Evolocumab or Alirocumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolocumab or AlirocumabDrug
All patients are treated with PCSK-9 inhibitors (Evolocumab or Alirocumab) to lower cholesterol
| Study group | Role | What they receive |
|---|---|---|
| Lipid lowering | Experimental | Not described Receives: Drug: Evolocumab or Alirocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular inflammation
Change in standard uptake value (SUV) of flourdeoxyglucose (FDG) before and after initiation of lipid lowering therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2020 (estimated)
- Study completion1 Oct 2020
Why it stopped: Logistic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Lowering, Vascular InflammationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus S. Ripa, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Rasmus S Ripa, MD, DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941016
- Sponsor's protocol ID
- 0002
- Status last verified
- Oct 2020
- First submitted
- 18 Oct 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Inflammation and Cholesterol Lowering Therapy
- ClinicalTrials.gov ID
- NCT02941016
- Acronym / sponsor ID
- 0002
- Conditions
- Lipid Lowering, Vascular Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistic reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 21 Oct 2016 (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 study aim to detect change in vascular inflammation following intense lipid lowering therapy
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipid lowering | Experimental | Drug: Evolocumab or Alirocumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- treatment with PCSK-9 inhibitors
Key exclusion criteria (1 listed)
- Infection Pregnancy Severe claustrophobia Weight >140 kg
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 or AlirocumabAll patients are treated with PCSK-9 inhibitors (Evolocumab or Alirocumab) to lower cholesterol | Drug | Lipid lowering |
Primary outcome
Change in vascular inflammation
Time frame: 12 weeks
Change in standard uptake value (SUV) of flourdeoxyglucose (FDG) before and after initiation of lipid lowering therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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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.
Rasmus S Ripa, MD, DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
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 or Alirocumab in people with Lipid Lowering, Vascular Inflammation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Oct 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 Denmark. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 vascular inflammation (time frame: 12 weeks). 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 14 Oct 2020.