Coronary Artery DiseasePhase 4ECLIPSENCT01490229
Ezetimibe Versus Nutraceuticals 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
Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with… Read more about this study
- Who is it for?
- Any age
- 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
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, 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 12 months) withdrawn of a statin due to side effects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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Pisana
Rome, 00100
Giuseppe Marazzi, MD, +39 335 8381320, giuseppe.marazzi@yahoo.com
About this study
Official title: Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention
Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will compare the efficacy and tolerability of ezetimibe versus 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 versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
- Conditions
- Coronary Artery Disease
- Being tested
- Ezetimibe, Nutraceuticals
- Keywords
- nutraceuticals, statin
- 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 ®, Merck, USA
os, 10 mg, once daily, 1 year
NutraceuticalsDrug
Also called Armolipid Plus, Rottapharm Madaus, Italy
os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe | Active comparator | Patients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day) Receives: Drug: Ezetimibe |
| Nutraceuticals | Active comparator | Patients assigned to nutraceuticals will receive for 1 year 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg Receives: Drug: Nutraceuticals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of treatment tolerability
Reasons for treatment discontinuation
Measured: Up to 12 months
Secondary outcomes (1)
Evaluation of drug effects on lipid and metabolic features
Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2016 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 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
- NCT01490229
- Sponsor's protocol ID
- 651/2011/D
- Acronym
- ECLIPSE
- Status last verified
- Mar 2013
- First submitted
- 8 Dec 2011
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention
- ClinicalTrials.gov ID
- NCT01490229
- Acronym / sponsor ID
- ECLIPSE / 651/2011/D
- Conditions
- Coronary Artery Disease
- Keywords
- nutraceuticals, statin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Dec 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.
Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will compare the efficacy and tolerability of ezetimibe versus 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 versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe | Active comparator | Drug: EzetimibePatients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day) |
| Nutraceuticals | Active comparator | Drug: NutraceuticalsPatients assigned to nutraceuticals will receive for 1 year 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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
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: Zetia ®, Merck, USAos, 10 mg, once daily, 1 year | Drug | Ezetimibe |
| NutraceuticalsAlso: Armolipid Plus, Rottapharm Madaus, Italyos, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year | Drug | Nutraceuticals |
Primary outcome
Evaluation of treatment tolerability
Time frame: Up to 12 months
Reasons for treatment discontinuation
1 secondary outcome
Evaluation of drug effects on lipid and metabolic features
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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 7 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?
Contact Francesco Pelliccia, MD (+393483392006, f.pelliccia@mclink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of treatment tolerability (time frame: Up to 12 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 7 Mar 2013.