Low Dose Statins, Ezetimibe and Nutraceuticals (TACO)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
statin + ezetimibe
statin + ezetimibe + Nutraceuticals
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, LDL cholesterol, therapeutic target
Eligibility Criteria
Inclusion Criteria:
Patients with angiographically assessed diagnosis of coronary artery disease
Exclusion Criteria:
None
Sites / Locations
- Sapienza University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
statin + ezetimibe
statin + ezetimibe + Nutraceuticals
Arm Description
Low dose statin associated with ezetimibe
Low dose statin associated with ezetimibe and Nutraceuticals
Outcomes
Primary Outcome Measures
Therapeutic target
LDL cholesterol < 70 mg/dl
Secondary Outcome Measures
Full Information
NCT ID
NCT03277079
First Posted
September 6, 2017
Last Updated
September 6, 2017
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT03277079
Brief Title
Low Dose Statins, Ezetimibe and Nutraceuticals
Acronym
TACO
Official Title
Low Dose Statins, Ezetimibe and Nutraceuticals in Coronary Artery Disease Patients Intolerant to High Intensity Statin Treatment (TArget ChOlesterol)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
March 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It remains unknown if the association between moderate to low intensity statin therapy and ezetimibe and nutraceuticals might have a therapeutic role in high-intensity statin intolerant patients
Detailed Description
The aim of this study will be to evaluate whether the association between statin and exetimibe vs statin + ezetimibe + nutraceuticals can lead to higher percentage of LDL target achievement
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, LDL cholesterol, therapeutic target
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
statin + ezetimibe
Arm Type
Active Comparator
Arm Description
Low dose statin associated with ezetimibe
Arm Title
statin + ezetimibe + Nutraceuticals
Arm Type
Active Comparator
Arm Description
Low dose statin associated with ezetimibe and Nutraceuticals
Intervention Type
Drug
Intervention Name(s)
statin + ezetimibe
Other Intervention Name(s)
Anticholesterol drug
Intervention Description
Combination of two drugs
Intervention Type
Drug
Intervention Name(s)
statin + ezetimibe + Nutraceuticals
Other Intervention Name(s)
Anticholesterol drug
Intervention Description
Combination of two grus plus nutraceuticals
Primary Outcome Measure Information:
Title
Therapeutic target
Description
LDL cholesterol < 70 mg/dl
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with angiographically assessed diagnosis of coronary artery disease
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Pelliccia, MD
Phone
39064997
Ext
123
Email
f.pelliccia@mclink.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Marazzi, MD
Phone
39064997
Ext
456
Email
marazzig@gmai.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Gaudio, MD
Organizational Affiliation
Sapienza University
Official's Role
Study Chair
Facility Information:
Facility Name
Sapienza University
City
Rome
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30420184
Citation
Marazzi G, Campolongo G, Pelliccia F, Calabro Md P, Cacciotti L, Vitale C, Massaro R, Volterrani M, Rosano G. Usefulness of Low-Dose Statin Plus Ezetimibe and/or Nutraceuticals in Patients With Coronary Artery Disease Intolerant to High-Dose Statin Treatment. Am J Cardiol. 2019 Jan 15;123(2):233-238. doi: 10.1016/j.amjcard.2018.09.041. Epub 2018 Oct 19.
Results Reference
derived
Learn more about this trial
Low Dose Statins, Ezetimibe and Nutraceuticals
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