AtherosclerosisNCT03273972
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
A study testing Written Informed Consent, Inclusion/Exclusion check and Full Clinical Chemistry and Haematology Bloods in people with Atherosclerosis and Cardiovascular Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 primary prevention in healthy volunteers by lowering LDL cholesterol using PCSK9 therapies. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases
- What is being tested?
- Written Informed Consent, Inclusion/Exclusion check and Full Clinical Chemistry and Haematology Bloods
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2017to 10 Oct 2018
- Phase
- Interventional
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: INvestigating the Lowest Threshold of Vascular bENefits From LDL Cholesterol Lowering With a PCSK9 mAb InhibiTor (Alirocumab) in healthY Volunteers
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 primary prevention in healthy volunteers by lowering LDL cholesterol using PCSK9 therapies. This research is being carried out because it is unclear what the lowest threshold of LDL cholesterol should be to attain significant reductions in CV risk in healthy individuals. It is also unknown whether there is a true limit of LDL cholesterol below which there is no further improvement in endothelial function in healthy people, and, whether this is associated with a reduction in markers of both systemic and vascular inflammation. This study will hope to provide evidence that the so-called pleiotropic effects of statins are actually mediated by a mechanism of LDL-cholesterol lowering per se and not necessarily a special therapeutic effect of statins.
Defining this may help identify individuals from the general population who may benefit from more aggressive lipid-lowering treatment than standard statin treatment in terms of CV morbidity and mortality.
Read more
This study will be conducted in healthy volunteers only, where participants will be randomized to either the Alirocumab arm (which is a therapy designed to lower cholesterol) or comparator arm. Both Alirocumab and comparator arms will be combined with Atorvastatin (another therapy designed to lower cholesterol) at the second dosing visit.
In total, thirty healthy individuals will be recruited to this single centre, randomized, single blind, parallel group, mechanistic physiological study which will be conducted at Cambridge University Hospitals NHS Foundation Trust/University of Cambridge. This study will be open to recruitment for one year and the total study duration for each participant will be approximately 10 weeks. There will be 4 study visits in total with a telephone follow up at the end of the study. Of these visits, two will be dosing visits and the total duration of treatment is approx. 4 weeks.
A series of non-invasive haemodynamic assessments and minimally invasive procedures including blood tests and forearm blood flow measurements will be conducted prior, during and post dosing to determine if there is an improvement of endothelia vascular function (as measured by nitric oxide bioavailability) and reduced systemic inflammation. This study is funded by JP Moulton Charitable Foundation.
- Conditions
- Atherosclerosis, Cardiovascular Diseases
- Being tested
- Written Informed Consent, Inclusion/Exclusion check, Full Clinical Chemistry and Haematology Bloods, Serum sample for systemic markers and lipid sub-fractions, Pregnancy Test
- Keywords
- Healthy Volunteers, Low Density Lipoprotein Cholesterol (LDL), PCSK9, Alirocumab, Forearm Blood Flow, Arterial Stiffness, Carotid Intima Media Thickness, Inflammation, Endothelial function
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Informed ConsentOther
To be completed prior to conducting any study related procedures
Inclusion/Exclusion checkOther
Eligibility check
Full Clinical Chemistry and Haematology BloodsOther
Participant required to fast for at least 6-8 hoursprior to visit. (Clear, non-caffeinated fluids are allowed)
Serum sample for systemic markers and lipid sub-fractionsOther
Serum samples may be stored for later analysis.
Pregnancy TestOther
If applicable for women of child bearing potential
12 Lead ECGOther
participant resting supine
Blood Pressure and Heart RateOther
Measured in the seated position after 5 minutes rest
Arterial StiffnessOther
Measure of functional and structural changes which accompanies cardiovascular disease
Central HaemodynamicsOther
Measure of functional and structural changes which accompanies cardiovascular disease
Carotid Intima Media ThicknessOther
Measurements will be repeated three times, and the average of the median values will be recorded
Forearm blood flow studiesOther
Assess and determine vascular function, which can interrogate endothelium dependent and independent mechanisms of nitric oxide bioavailability
Concomitant medication checkOther
Review of medication taken by the participant
Medication compliance check (Pill count)Other
Ensure prescribed statin has been taken
Physical examinationOther
Check overall health
Medical historyOther
Review of volunteers medial history
AE/SAE review & reportingOther
Monitor safety from the point of consent
DosingDrug
To be performed at the end of the visit following completion all other study visits
| Study group | Role | What they receive |
|---|---|---|
| Alirocumab Treatment Arm | Experimental | V2: Day 1 - Alirocumab 150mg (subcutaneous injection) V3: Day 15 +/- 3 days - Alirocumab 150mg (subcutaneous injection) plus Atorvastatin 20mg (oral) approx. 14 days prescription. Receives: Other: Written Informed Consent; Other: Inclusion/Exclusion check; Other: Full Clinical Chemistry and Haematology Bloods; Other: Serum sample for systemic markers and lipid sub-fractions; Other: Pregnancy Test; Other: 12 Lead ECG; Other: Blood Pressure and Heart Rate; Other: Arterial Stiffness; Other: Central Haemodynamics; Other: Carotid Intima Media Thickness; Other: Forearm blood flow studies; Other: Concomitant medication check; Other: Medication compliance check (Pill count); Other: Physical examination; Other: Medical history; Other: AE/SAE review & reporting; Drug: Dosing |
| Comparator Treatment Arm | Other | V2: Day 1 - Placebo (subcutaneous injection) V3: Day 15 +/- 3 days - Placebo (subcutaneous injection) plus Atorvastatin 20mg (oral) approx. 14 days prescription. Receives: Other: Written Informed Consent; Other: Inclusion/Exclusion check; Other: Full Clinical Chemistry and Haematology Bloods; Other: Serum sample for systemic markers and lipid sub-fractions; Other: Pregnancy Test; Other: 12 Lead ECG; Other: Blood Pressure and Heart Rate; Other: Arterial Stiffness; Other: Central Haemodynamics; Other: Carotid Intima Media Thickness; Other: Forearm blood flow studies; Other: Concomitant medication check; Other: Medication compliance check (Pill count); Other: Physical examination; Other: Medical history; Other: AE/SAE review & reporting; Drug: Dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm Blood Flow (FBF) - In response to intra-arterial Acetylcholine infusion, comparing Alirocumab to placebo.
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
Measured: 4 weeks
Secondary outcomes (14)
Forearm Blood Flow in response to intra-arterial Acetylcholine infusion, comparing Alirocumab to statin.
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
Measured: 4 weeks
Forearm blood flow in response to intra-arterial Acetylcholine infusion, comparing Alirocumab with statin to statin alone.
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
Measured: 4 weeks
Forearm blood flow in response to intra-arterial Sodium Nitroprusside, comparing Alirocumab to placebo.
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
Measured: 4 weeks
Forearm blood flow in response to intra-arterial Sodium Nitroprusside, comparing Alirocumab to statin.
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
Measured: 4 weeks
Forearm blood flow in response to intra-arterial Sodium Nitroprusside, comparing Alirocumab with statin to statin alone.
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
Measured: 4 weeks
Forearm blood flow in response to intra-arterial L-NMMA infusion, comparing Alirocumab to placebo.
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
Measured: 4 weeks
Forearm blood flow in response to intra-arterial L-NMMA infusion, comparing Alirocumab to statin.
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
Measured: 4 weeks
Forearm blood flow in response to intra-arterial L-NMMA infusion, comparing Alirocumab with statin to statin alone.
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
Measured: 4 weeks
Total and LDL-cholesterol
Correlation of change in responses to Acetylcholine between groups.
Measured: 4 weeks
Augmentation Index (an indicator of arterial stiffness)
Change in Augmentation Index between visits and different treatment regimes.
Measured: 4 weeks
Pulse Wave Velocity
Change in aortic Pulse Wave Velocity between visits and different treatment regimes.
Measured: 4 weeks
Carotid IMT
Change in Carotid IMT between visits and different treatment regimes.
Measured: 4 weeks
Systemic inflammation
Change in lipid profile, hsCRP and other markers of systemic inflammation between visits and different treatment regimes.
Measured: 4 weeks
Physical examination, vital signs, ECG, laboratory tests and adverse event assessment to determine Safety and tolerability parameters
Including physical examination, blood pressure, heart rate, 12-lead electrocardiograms (ECGs), clinical laboratory tests side effects and adverse event reporting.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start7 Sep 2017
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation to be performed to a 1:1 ratio. Alirocumab treatment arm: * V2: Alirocumab (150mg) * V3: Alirocumab (150mg) \& Atorvastatin (20mg) Comparator treatment arm * V2: Placebo * V3: Placebo \& Atorvastatin (20mg)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Joseph Cheriyan, MBChB, FRCP, MA, Principal investigator, Cambridge University Hospitals NHS Foundation TrustMichalis Kostapanos, MD, PhD, FRSPH, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273972
- Sponsor's protocol ID
- INTENSITY-LOW
- Status last verified
- Jul 2023
- First submitted
- 14 Aug 2017
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the minimum required participant identifiable information (name and contact details) will be provided to the research team for the purpose of arranging study visits and completing the informed consent process. All delegated research personnel that is responsible to conduct the data/statistical analysis will only analyse data that is anonymised of any patient identifiable data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INvestigating the Lowest Threshold of Vascular bENefits From LDL Cholesterol Lowering With a PCSK9 mAb InhibiTor (Alirocumab) in healthY Volunteers
- ClinicalTrials.gov ID
- NCT03273972
- Acronym / sponsor ID
- INTENSITY-LOW
- Conditions
- Atherosclerosis, Cardiovascular Diseases
- Keywords
- Healthy Volunteers, Low Density Lipoprotein Cholesterol (LDL), PCSK9, Alirocumab, Forearm Blood Flow, Arterial Stiffness, Carotid Intima Media Thickness, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 6 Sep 2017 (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.
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 primary prevention in healthy volunteers by lowering LDL cholesterol using PCSK9 therapies. This research is being carried out because it is unclear what the lowest threshold of LDL cholesterol should be to attain significant reductions in CV risk in healthy individuals. It is also unknown whether there is a true limit of LDL cholesterol below which there is no further improvement in endothelial function in healthy people, and, whether this is associated with a reduction in markers of both systemic and vascular inflammation. This study will hope to provide evidence that the so-called pleiotropic effects of statins are actually mediated by a mechanism of LDL-cholesterol lowering per se and not necessarily a special therapeutic effect of statins.
Defining this may help identify individuals from the general population who may benefit from more aggressive lipid-lowering treatment than standard statin treatment in terms of CV morbidity and mortality.
This study will be conducted in healthy volunteers only, where participants will be randomized to either the Alirocumab arm (which is a therapy designed to lower cholesterol) or comparator arm. Both Alirocumab and comparator arms will be combined with Atorvastatin (another therapy designed to lower cholesterol) at the second dosing visit.
In total, thirty healthy individuals will be recruited to this single centre, randomized, single blind, parallel group, mechanistic physiological study which will be conducted at Cambridge University Hospitals NHS Foundation Trust/University of Cambridge. This study will be open to recruitment for one year and the total study duration for each participant will be approximately 10 weeks. There will be 4 study visits in total with a telephone follow up at the end of the study. Of these visits, two will be dosing visits and the total duration of treatment is approx. 4 weeks.
A series of non-invasive haemodynamic assessments and minimally invasive procedures including blood tests and forearm blood flow measurements will be conducted prior, during and post dosing to determine if there is an improvement of endothelia vascular function (as measured by nitric oxide bioavailability) and reduced systemic inflammation. This study is funded by JP Moulton Charitable Foundation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomisation to be performed to a 1:1 ratio. Alirocumab treatment arm: * V2: Alirocumab (150mg) * V3: Alirocumab (150mg) \& Atorvastatin (20mg) Comparator treatment arm * V2: Placebo * V3: Placebo \& Atorvastatin (20mg)
| Arm | Type | Receives |
|---|---|---|
| Alirocumab Treatment Arm | Experimental | Other: Written Informed Consent, Other: Inclusion/Exclusion check, Other: Full Clinical Chemistry and Haematology Bloods, Other: Serum sample for systemic markers and lipid sub-fractions, Other: Pregnancy Test, Other: 12 Lead ECG, Other: Blood Pressure and Heart Rate, Other: Arterial Stiffness, Other: Central Haemodynamics, Other: Carotid Intima Media Thickness, Other: Forearm blood flow studies, Other: Concomitant medication check, Other: Medication compliance check (Pill count), Other: Physical examination, Other: Medical history, Other: AE/SAE review & reporting, Drug: DosingV2: Day 1 - Alirocumab 150mg (subcutaneous injection) V3: Day 15 +/- 3 days - Alirocumab 150mg (subcutaneous injection) plus Atorvastatin 20mg (oral) approx. 14 days prescription. |
| Comparator Treatment Arm | Other | Other: Written Informed Consent, Other: Inclusion/Exclusion check, Other: Full Clinical Chemistry and Haematology Bloods, Other: Serum sample for systemic markers and lipid sub-fractions, Other: Pregnancy Test, Other: 12 Lead ECG, Other: Blood Pressure and Heart Rate, Other: Arterial Stiffness, Other: Central Haemodynamics, Other: Carotid Intima Media Thickness, Other: Forearm blood flow studies, Other: Concomitant medication check, Other: Medication compliance check (Pill count), Other: Physical examination, Other: Medical history, Other: AE/SAE review & reporting, Drug: DosingV2: Day 1 - Placebo (subcutaneous injection) V3: Day 15 +/- 3 days - Placebo (subcutaneous injection) plus Atorvastatin 20mg (oral) approx. 14 days prescription. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Written Informed ConsentTo be completed prior to conducting any study related procedures | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Inclusion/Exclusion checkEligibility check | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Full Clinical Chemistry and Haematology BloodsParticipant required to fast for at least 6-8 hoursprior to visit. (Clear, non-caffeinated fluids are allowed) | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Serum sample for systemic markers and lipid sub-fractionsSerum samples may be stored for later analysis. | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Pregnancy TestIf applicable for women of child bearing potential | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| 12 Lead ECGparticipant resting supine | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Blood Pressure and Heart RateMeasured in the seated position after 5 minutes rest | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Arterial StiffnessMeasure of functional and structural changes which accompanies cardiovascular disease | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Central HaemodynamicsMeasure of functional and structural changes which accompanies cardiovascular disease | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Carotid Intima Media ThicknessMeasurements will be repeated three times, and the average of the median values will be recorded | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Forearm blood flow studiesAssess and determine vascular function, which can interrogate endothelium dependent and independent mechanisms of nitric oxide bioavailability | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Concomitant medication checkReview of medication taken by the participant | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Medication compliance check (Pill count)Ensure prescribed statin has been taken | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Physical examinationCheck overall health | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| Medical historyReview of volunteers medial history | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| AE/SAE review & reportingMonitor safety from the point of consent | Other | Alirocumab Treatment Arm, Comparator Treatment Arm |
| DosingTo be performed at the end of the visit following completion all other study visits | Drug | Alirocumab Treatment Arm, Comparator Treatment Arm |
Primary outcome
Forearm Blood Flow (FBF) - In response to intra-arterial Acetylcholine infusion, comparing Alirocumab to placebo.
Time frame: 4 weeks
Change in FBF ratio, as measured by absolute \& percent change in venous occlusion plethysmography
14 secondary outcomes
Forearm Blood Flow in response to intra-arterial Acetylcholine infusion, comparing Alirocumab to statin.
Time frame: 4 weeks
Forearm blood flow in response to intra-arterial Acetylcholine infusion, comparing Alirocumab with statin to statin alone.
Time frame: 4 weeks
Forearm blood flow in response to intra-arterial Sodium Nitroprusside, comparing Alirocumab to placebo.
Time frame: 4 weeks
Forearm blood flow in response to intra-arterial Sodium Nitroprusside, comparing Alirocumab to statin.
Time frame: 4 weeks
Forearm blood flow in response to intra-arterial Sodium Nitroprusside, comparing Alirocumab with statin to statin alone.
Time frame: 4 weeks
Forearm blood flow in response to intra-arterial L-NMMA infusion, comparing Alirocumab to placebo.
Time frame: 4 weeks
Forearm blood flow in response to intra-arterial L-NMMA infusion, comparing Alirocumab to statin.
Time frame: 4 weeks
Forearm blood flow in response to intra-arterial L-NMMA infusion, comparing Alirocumab with statin to statin alone.
Time frame: 4 weeks
Total and LDL-cholesterol
Time frame: 4 weeks
Augmentation Index (an indicator of arterial stiffness)
Time frame: 4 weeks
Pulse Wave Velocity
Time frame: 4 weeks
Carotid IMT
Time frame: 4 weeks
Systemic inflammation
Time frame: 4 weeks
Physical examination, vital signs, ECG, laboratory tests and adverse event assessment to determine Safety and tolerability parameters
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No. Only the minimum required participant identifiable information (name and contact details) will be provided to the research team for the purpose of arranging study visits and completing the informed consent process. All delegated research personnel that is responsible to conduct the data/statistical analysis will only analyse data that is anonymised of any patient identifiable data.
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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.
Joseph Cheriyan, MBChB, FRCP, MA principal investigator
Cambridge University Hospitals NHS Foundation Trust
Michalis Kostapanos, MD, PhD, FRSPH principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Informed Consent, Inclusion/Exclusion check and Full Clinical Chemistry and Haematology Bloods in people with Atherosclerosis and Cardiovascular Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 17 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: finished, as of the sponsor's last update on 27 Jul 2023. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forearm Blood Flow (FBF) - In response to intra-arterial Acetylcholine infusion, comparing Alirocumab to placebo. (time frame: 4 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 27 Jul 2023.