Vascular Inflammation and Cholesterol Lowering Therapy | NCT02941016

Studies
Vascular Inflammation and Cholesterol Lowering Therapy

NCT02941016

Sponsor

Rigshospitalet, Denmark

Status

Withdrawn

Last Update Posted

Oct 14, 2020Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Lipid Lowering, Vascular Inflammation

Interventions

Evolocumab or Alirocumab

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Logistic reasons

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2020Estimated

Completion Date

Oct 1, 2020Actual

First Submitted Date

Oct 18, 2016

First Submission Date that Met QC Criteria

Oct 20, 2016

First Posted Date

Oct 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2020

Last Update Posted Date

Oct 14, 2020Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lipid lowering	Experimental		Drug: Evolocumab or Alirocumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab or Alirocumab	Drug	All patients are treated with PCSK-9 inhibitors (Evolocumab or Alirocumab) to lower cholesterol	Lipid lowering

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in vascular inflammation	Change in standard uptake value (SUV) of flourdeoxyglucose (FDG) before and after initiation of lipid lowering therapy	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

treatment with PCSK-9 inhibitors

Exclusion Criteria:

Infection Pregnancy Severe claustrophobia Weight >140 kg

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rasmus S Ripa, MD, DMSc	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen			Denmark

Intervention Browse Module

MeSH Terms

ID	Term
C577155	evolocumab
C571059	alirocumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided