INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 7, 2017

Primary Completion Date

October 10, 2018

Study Completion Date

October 10, 2018

Conditions
AtherosclerosisCardiovascular Diseases
Interventions
OTHER

Written Informed Consent

To be completed prior to conducting any study related procedures

OTHER

Inclusion/Exclusion check

Eligibility check

OTHER

Full Clinical Chemistry and Haematology Bloods

Participant required to fast for at least 6-8 hoursprior to visit. (Clear, non-caffeinated fluids are allowed)

OTHER

Serum sample for systemic markers and lipid sub-fractions

Serum samples may be stored for later analysis.

OTHER

Pregnancy Test

If applicable for women of child bearing potential

OTHER

12 Lead ECG

participant resting supine

OTHER

Blood Pressure and Heart Rate

Measured in the seated position after 5 minutes rest

OTHER

Arterial Stiffness

Measure of functional and structural changes which accompanies cardiovascular disease

OTHER

Central Haemodynamics

Measure of functional and structural changes which accompanies cardiovascular disease

OTHER

Carotid Intima Media Thickness

Measurements will be repeated three times, and the average of the median values will be recorded

OTHER

Forearm blood flow studies

Assess and determine vascular function, which can interrogate endothelium dependent and independent mechanisms of nitric oxide bioavailability

OTHER

Concomitant medication check

Review of medication taken by the participant

OTHER

Medication compliance check (Pill count)

Ensure prescribed statin has been taken

OTHER

Physical examination

Check overall health

OTHER

Medical history

Review of volunteers medial history

OTHER

AE/SAE review & reporting

Monitor safety from the point of consent

DRUG

Dosing

To be performed at the end of the visit following completion all other study visits

Trial Locations (1)

CB2 0QQ

Addenbrooke's Hospital, Cambridge

All Listed Sponsors
collaborator

University of Cambridge

OTHER

lead

Cambridge University Hospitals NHS Foundation Trust

OTHER

NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers | Biotech Hunter | Biotech Hunter