Coronary Artery DiseasePhase 4CHOLESSNCT01807078
Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients
A Phase 4 study testing Ezetimibe and Nutraceuticals in people with Coronary Artery Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects. Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ezetimibe and Nutraceuticals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Dec 2017
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angiographically-proven coronary artery disease
- Recent (<12 months) percutaneous coronary intervention
- Class I indication to receive statin treatment
- Previous (<12 months) withdrawn of a statin due to side effects
- Unwilling to receive treatment with an alternative statin
- Able to understand and willing to sign the informed consent form
Who cannot join
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Trial locations and contacts
1 site in 1 country.
Italy1 site
Sapienza University
Rome, Lazio, 00161
Francesco Pelliccia, MD, +39064997 ext. 123, f.pelliccia@mclink.it
Giuseppe Marazzi, MD, +39064997 ext. 123, md4151@mclink.it
About this study
Official title: Randomized Comparison of the CHOlesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant patientS - The CHOLESS Trial
Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.
Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).
It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.
The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Read the detailed description
Background
Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.
Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).
It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.
Purpose
The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Study Population
Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects
Randomization
Patients will be randomized to receive for 6 months either ezetimibe (10 mg/day) or a commercially available nutraceutical combined pill (1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg).
- Conditions
- Coronary Artery Disease
- Being tested
- Ezetimibe, Nutraceuticals
- Keywords
- Coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Also called Zetia
10 mg p.d. of ezetimibe
NutraceuticalsDietary supplement
Also called Choless, Fixlipid
1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe | Active comparator | Patients will receive for 6 months ezetimibe (10 mg/day) Receives: Drug: Ezetimibe |
| Nutraceuticals | Active comparator | Patients will receive for 6 months a commercially available nutraceutical combined pill (1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg Receives: Dietary Supplement: Nutraceuticals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reasons for treatment discontinuation
Reasons for treatment discontinuation
Measured: 6 months
Secondary outcomes (1)
Effects on lipid profile
Effects on cholesterol plasmatic levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807078
- Sponsor's protocol ID
- 222-D-2013
- Acronym
- CHOLESS
- Status last verified
- Mar 2013
- First submitted
- 6 Mar 2013
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of the CHOlesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant patientS - The CHOLESS Trial
- ClinicalTrials.gov ID
- NCT01807078
- Acronym / sponsor ID
- CHOLESS / 222-D-2013
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Mar 2013 (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.
Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.
Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).
It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.
The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Detailed description
Background
Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.
Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).
It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.
Purpose
The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Study Population
Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects
Randomization
Patients will be randomized to receive for 6 months either ezetimibe (10 mg/day) or a commercially available nutraceutical combined pill (1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe | Active comparator | Drug: EzetimibePatients will receive for 6 months ezetimibe (10 mg/day) |
| Nutraceuticals | Active comparator | Dietary Supplement: NutraceuticalsPatients will receive for 6 months a commercially available nutraceutical combined pill (1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Angiographically-proven coronary artery disease
- Recent (<12 months) percutaneous coronary intervention
- Class I indication to receive statin treatment
- Previous (<12 months) withdrawn of a statin due to side effects
- Unwilling to receive treatment with an alternative statin
Key exclusion criteria (1 listed)
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
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 |
|---|---|---|
| EzetimibeAlso: Zetia10 mg p.d. of ezetimibe | Drug | Ezetimibe |
| NutraceuticalsAlso: Choless, Fixlipid1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg | Dietary supplement | Nutraceuticals |
Primary outcome
Reasons for treatment discontinuation
Time frame: 6 months
Reasons for treatment discontinuation
1 secondary outcome
Effects on lipid profile
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ezetimibe and Nutraceuticals in people with Coronary Artery Disease, run by University of Roma La Sapienza at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reasons for treatment discontinuation (time frame: 6 months). 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 8 Mar 2013.