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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
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 6, 2017
Last Updated
September 6, 2017
Sponsor
University of Roma La Sapienza
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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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