Peripheral Arterial DiseaseNCT01391377
Effects of Niacin on Good Cholesterol in People With Peripheral Arterial Disease
A study testing Niacin/Laropiprant combination and Sugar pill in people with Peripheral Arterial Disease, run by Bayside Health at 1 site in Australia.
Trial summary
Atherosclerosis is a disorder in the body that is characterized by cholesterol plaque formation in various arteries, causing narrowing of the artery and a limitation in blood flow. Depending on which artery the plaque is in, different clinical conditions occur. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Niacin/Laropiprant combination and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2011to Dec 2014
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >40 years
- ankle-brachial index (ABI) of <0.9 at rest in at least one leg,
- symptom limiting intermittent claudication (unilateral or bilateral) and stable for the previous 6 months,
- superficial femoral artery disease amenable to percutaneous revascularisation,
- serum HDL <1.0 mmol/l
- a stable medication regime for at least 6 months
Who cannot join
- acute myocardial infarction or presentation with angina within 1 month of enrolment,
- serum creatinine >0.2mmol/l,
- significant co-morbidity with expected survival <6 months,
- current niacin or fibrate therapy
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Australia1 site
Baker IDI Heart and diabetes research institute
Melbourne, Victoria, 3004
About this study
Official title: The Effects of Chronic High-density Lipoprotein (HDL) Elevation With Extended Release Niacin on Peripheral Arterial Disease
Atherosclerosis is a disorder in the body that is characterized by cholesterol plaque formation in various arteries, causing narrowing of the artery and a limitation in blood flow. Depending on which artery the plaque is in, different clinical conditions occur. In adults common areas include in the heart arteries, in the neck arteries and in the aorta and lower leg arteries. When it affects the lower limbs it is known as peripheral arterial disease - PAD.
The main symptom of PAD is called "claudication" and is described as pain or discomfort in the legs when walking. The aim of PAD treatment is to improve walking distance and quality of life in those with intermittent claudication, and to decrease long term complications including illness and death.
Read more
An important controlling factor of these cholesterol plaques is a type of cholesterol called HDL (High density lipoprotein).
This study aims to look at the effect that raising HDL for a prolonged period has on blood markers of inflammation and on the cholesterol plaque composition in patients with PAD. This investigation will also have relevance to the effects of HDL elevation on plaque composition and inflammation in other areas of the body including the heart, neck and brain arteries.
Twenty (20) PAD patients with will be recruited into the study. The investigators anticipate recruitment of all 20 patients within 12 months. The 20 PAD patients all must have significant leg pains when walking, and after review by a doctor, be determined to have narrowings in the leg artery that they will plan to operate on. Patients will be randomized to either niacin (Tredaptive, 1g/day) or matching placebo for 8 weeks (prior to operation) After the 8 week period they will then go on to receive the normal interventional treatment as planned. Blood samples will be taken at enrollment and at the 8 week mark prior to surgery. The plaque that is removed at the time of operation will also be sent to the lab for analysis.
The investigators hope to show with this study that by raising the levels of HDL with extended release niacin, there are positive effects on the amount of cholesterol in the plaque, and on the markers in the blood of inflammation and thrombosis.
The hypothesis is that elevation of HDL with Niacin will have anti-atherosclerotic actions including: Lower plaque lipid content, Reduced plaque macrophage infiltration, Reduced monocyte activation, Reduced neutrophil adhesion, Inhibition of inflammation and Inhibition of thrombotic markers.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Niacin/Laropiprant combination, Sugar pill
- Keywords
- HDL, High density Lipoprotein, Peripheral arterial disease, Tredaptive, Niacin, Laropiprant, Plaque, Atherosclerosis, Lipid content
- Medical subject headings
- Peripheral Arterial Disease, Plaque, Amyloid, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin/Laropiprant combinationDrug
Also called Tredaptive
Niacin 1g / Laropiprant 20mg for 4 weeks followed by Niacin 2g / Laropiprant 20mg for 4 weeks
Sugar pillDrug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Niacin / Laropiprant | Active comparator | Not described Receives: Drug: Niacin/Laropiprant combination |
| Sugar Pill (Placebo) | Placebo comparator | Not described Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque composition
After femoral arthrectomy the excised plaque will analysed for histological studies, for lipid content, immunohistochemistry, macrophage content and size and VCAM-1 staining.
Measured: 8 weeks after recruitment.
Secondary outcomes (7)
Plasma Monocyte Activation
Cd11b expression on peripheral blood monocytes will be measured as a marker of monocyte activation.
Measured: 8 weeks after recruitment
Plasma Neutrophil Adhesion to Immobilized Fibrinogen
Measured: 8 weeks after recruitment
Platelet Aggregation Assays
Measured: 8 weeks after recruitment
Plasma Thrombotic Markers
Measured: 8 weeks after recruitment
Size distribution and composition of HDL
Measured: 8 weeks after recruitment
Ex vivo cholesterol efflux
Measured: 8 weeks after recruitment
Plasma lipid parameters and inflammatory markers
Lipid levels including total cholesterol, HDL, LDL and TGs, will be measured as well as ApoA1 protien and Plasma soluble ICAM-1 and soluble VCAM-1. TNF-A levels will also be measured and CRP.
Measured: 8 weeks after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: Tredaptive has been suspended worldwide
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- Bronwyn Kingwell, Bsc, PhD, Principal investigator, Baker IDI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391377
- Sponsor's protocol ID
- 126-11
- Status last verified
- Feb 2013
- First submitted
- 5 Apr 2011
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chronic High-density Lipoprotein (HDL) Elevation With Extended Release Niacin on Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01391377
- Acronym / sponsor ID
- 126-11
- Conditions
- Peripheral Arterial Disease
- Keywords
- HDL, High density Lipoprotein, Peripheral arterial disease, Tredaptive, Niacin, Laropiprant, Plaque, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Tredaptive has been suspended worldwide
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 Jul 2011 (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.
Atherosclerosis is a disorder in the body that is characterized by cholesterol plaque formation in various arteries, causing narrowing of the artery and a limitation in blood flow. Depending on which artery the plaque is in, different clinical conditions occur. In adults common areas include in the heart arteries, in the neck arteries and in the aorta and lower leg arteries. When it affects the lower limbs it is known as peripheral arterial disease - PAD.
The main symptom of PAD is called "claudication" and is described as pain or discomfort in the legs when walking. The aim of PAD treatment is to improve walking distance and quality of life in those with intermittent claudication, and to decrease long term complications including illness and death.
An important controlling factor of these cholesterol plaques is a type of cholesterol called HDL (High density lipoprotein).
This study aims to look at the effect that raising HDL for a prolonged period has on blood markers of inflammation and on the cholesterol plaque composition in patients with PAD. This investigation will also have relevance to the effects of HDL elevation on plaque composition and inflammation in other areas of the body including the heart, neck and brain arteries.
Twenty (20) PAD patients with will be recruited into the study. The investigators anticipate recruitment of all 20 patients within 12 months. The 20 PAD patients all must have significant leg pains when walking, and after review by a doctor, be determined to have narrowings in the leg artery that they will plan to operate on. Patients will be randomized to either niacin (Tredaptive, 1g/day) or matching placebo for 8 weeks (prior to operation) After the 8 week period they will then go on to receive the normal interventional treatment as planned. Blood samples will be taken at enrollment and at the 8 week mark prior to surgery. The plaque that is removed at the time of operation will also be sent to the lab for analysis.
The investigators hope to show with this study that by raising the levels of HDL with extended release niacin, there are positive effects on the amount of cholesterol in the plaque, and on the markers in the blood of inflammation and thrombosis.
The hypothesis is that elevation of HDL with Niacin will have anti-atherosclerotic actions including: Lower plaque lipid content, Reduced plaque macrophage infiltration, Reduced monocyte activation, Reduced neutrophil adhesion, Inhibition of inflammation and Inhibition of thrombotic markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Niacin / Laropiprant | Active comparator | Drug: Niacin/Laropiprant combination |
| Sugar Pill (Placebo) | Placebo comparator | Drug: Sugar pill |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age >40 years
- ankle-brachial index (ABI) of <0.9 at rest in at least one leg,
- symptom limiting intermittent claudication (unilateral or bilateral) and stable for the previous 6 months,
- superficial femoral artery disease amenable to percutaneous revascularisation,
- serum HDL <1.0 mmol/l
Key exclusion criteria (5 listed)
- acute myocardial infarction or presentation with angina within 1 month of enrolment,
- serum creatinine >0.2mmol/l,
- significant co-morbidity with expected survival <6 months,
- current niacin or fibrate therapy
- unable to give informed consent
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 |
|---|---|---|
| Niacin/Laropiprant combinationAlso: TredaptiveNiacin 1g / Laropiprant 20mg for 4 weeks followed by Niacin 2g / Laropiprant 20mg for 4 weeks | Drug | Niacin / Laropiprant |
| Sugar pillAlso: PlaceboPlacebo | Drug | Sugar Pill (Placebo) |
Primary outcome
Plaque composition
Time frame: 8 weeks after recruitment.
After femoral arthrectomy the excised plaque will analysed for histological studies, for lipid content, immunohistochemistry, macrophage content and size and VCAM-1 staining.
7 secondary outcomes
Plasma Monocyte Activation
Time frame: 8 weeks after recruitment
Plasma Neutrophil Adhesion to Immobilized Fibrinogen
Time frame: 8 weeks after recruitment
Platelet Aggregation Assays
Time frame: 8 weeks after recruitment
Plasma Thrombotic Markers
Time frame: 8 weeks after recruitment
Size distribution and composition of HDL
Time frame: 8 weeks after recruitment
Ex vivo cholesterol efflux
Time frame: 8 weeks after recruitment
Plasma lipid parameters and inflammatory markers
Time frame: 8 weeks after recruitment
Results and safety
The study was stopped early (reason given: Tredaptive has been suspended worldwide). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Bronwyn Kingwell, Bsc, PhD principal investigator
Baker IDI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niacin/Laropiprant combination and Sugar pill in people with Peripheral Arterial Disease, run by Bayside Health at 1 site in Australia.
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 5 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: stopped early, as of the sponsor's last update on 27 Feb 2013. 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 Australia. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Tredaptive has been suspended worldwide). Results are not available in the source record.
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?
Plaque composition (time frame: 8 weeks after recruitment.). 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 Feb 2013.