Status:
COMPLETED
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Cambridge
Conditions:
Atherosclerosis
Cardiovascular Diseases
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The INTENSITY-LOW study aims to answer if there are any limits to LDL reduction in relation to benefitting vascular health from a mechanistic viewpoint, and therefore potentially limitations to primar...
Eligibility Criteria
Inclusion
- Apparently healthy male or female individuals
- Age 18-45 years old inclusive at screening
- Body weight ≥ 45kg and BMI 18 -29.9 kg/m2
- Fasting LDL-C \< 4.1 mmol/l, TG \<1.7 mmol/l and HDL-C ≥ 1.0 mmol for men and ≥1.3 mmol for women
- Palpable brachial arterial pulse, as per study team assessment
- Not currently eligible for statin therapy according to current treatment criteria
Exclusion
- History of established CV disease (Coronary Heart Disease, Cerebrovascular Disease, Peripheral Vascular Disease or Abdominal Aortic Aneurysm)
- Lipid lowering treatment at screening or within 6 weeks before screening
- Pregnancy at any study visit
- Ongoing anticoagulation therapy with warfarin or any of the DOAC/NOAC's
- History of hypersensitivity to any of the study drugs/any known sensitivity to alirocumab or monoclonal antibodies
- History of alcohol or drug abuse or dependence within 6 months of the study at screening
- Current or previous history of regular smoking (defined as 1 pack-year) within the last 10 years.
- History of hypertension or sustained BP ≥140/90 mmHg on repeated measurements at screening
- History of type 1 or 2 diabetes or HbA1c ≥ 48 mmol/mol (6.5%) at screening
- Chronic kidney disease defined as eGFR \<60ml/min/1.73m2 at screening
- Biological first-degree relatives who have experienced stroke, TIA, myocardial infarction or peripheral vascular disease (incident event at an age younger than: 55 for male and 65 for female relatives)
- History of autoimmune inflammatory conditions
- Lack of ability to provide informed consent
- TSH \>5.0 mu/l at screening
- Clinically significant liver disease on the basis of screening bloods or history
- History of myositis/rhabdomyolysis
- Any concomitant condition that, at the discretion of the investigator, may affect the participants' ability to complete the study or the study results
Key Trial Info
Start Date :
September 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03273972
Start Date
September 7 2017
End Date
October 10 2018
Last Update
July 27 2023
Active Locations (1)
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1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ