Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients
CHOLESS
Randomized Comparison of the CHOlesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant patientS - The CHOLESS Trial
1 other identifier
interventional
200
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started Jan 2014
Typical duration for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2013
CompletedFirst Posted
Study publicly available on registry
March 8, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 8, 2013
March 1, 2013
1.9 years
March 6, 2013
March 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reasons for treatment discontinuation
Reasons for treatment discontinuation
6 months
Secondary Outcomes (1)
Effects on lipid profile
6 months
Study Arms (2)
Ezetimibe
ACTIVE COMPARATORPatients will receive for 6 months ezetimibe (10 mg/day)
Nutraceuticals
ACTIVE COMPARATORPatients 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
Interventions
1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sapienza University
Rome, Lazio, 00161, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 6, 2013
First Posted
March 8, 2013
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2017
Last Updated
March 8, 2013
Record last verified: 2013-03