## Protocol Section
### Identification Module
**NCT ID:** NCT03277079

**Acronym:** TACO

**Brief Title:** Low Dose Statins, Ezetimibe and Nutraceuticals

**Official Title:** Low Dose Statins, Ezetimibe and Nutraceuticals in Coronary Artery Disease Patients Intolerant to High Intensity Statin Treatment (TArget ChOlesterol)

#### Organization Study ID Info
**ID:** 123/D/2017
#### Organization
**Class:** OTHER
**Full Name:** University of Roma La Sapienza
### Status Module
#### Completion Date
**Date:** 2018-03-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2017-09-08

**Type:** ACTUAL

**Last Update Submit Date:** 2017-09-06

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-10-01

**Type:** ESTIMATED

**Status Verified Date:** 2017-09

#### Study First Post Date
**Date:** 2017-09-08
**Type:** ACTUAL
**Study First Submit Date:** 2017-09-06
**Study First Submit QC Date:** 2017-09-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Roma La Sapienza

#### Responsible Party

**Investigator Affiliation:** University of Roma La Sapienza

**Investigator Full Name:** Francesco Pelliccia

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Coronary Artery Disease

**Keywords:**

- coronary artery disease

- LDL cholesterol

- therapeutic target

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Low dose statin associated with ezetimibe

**Intervention Names:**

- Drug: statin + ezetimibe

- Drug: statin + ezetimibe + Nutraceuticals

**Label:** statin + ezetimibe

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Low dose statin associated with ezetimibe and Nutraceuticals

**Intervention Names:**

- Drug: statin + ezetimibe

- Drug: statin + ezetimibe + Nutraceuticals

**Label:** statin + ezetimibe + Nutraceuticals

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- statin + ezetimibe

- statin + ezetimibe + Nutraceuticals

**Description:** Combination of two drugs

**Name:** statin + ezetimibe

**Other Names:**

- Anticholesterol drug

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- statin + ezetimibe

- statin + ezetimibe + Nutraceuticals

**Description:** Combination of two grus plus nutraceuticals

**Name:** statin + ezetimibe + Nutraceuticals

**Other Names:**

- Anticholesterol drug

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** LDL cholesterol \< 70 mg/dl

**Measure:** Therapeutic target

**Time Frame:** Up to 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Patients with angiographically assessed diagnosis of coronary artery disease

Exclusion Criteria:

None

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** f.pelliccia@mclink.it

**Name:** Francesco Pelliccia, MD

**Phone:** 39064997

**Phone Ext:** 123

**Role:** CONTACT

**Contact 2:**

**Email:** marazzig@gmai.com

**Name:** Giuseppe Marazzi, MD

**Phone:** 39064997

**Phone Ext:** 456

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rome

**Country:** Italy

**Facility:** Sapienza University

**Zip:** 00161

#### Overall Officials

**Official 1:**

**Affiliation:** Sapienza University

**Name:** Carlo Gaudio, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 30420184

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003327

- Term: Coronary Disease

### Intervention Browse Module - Ancestors

- ID: D000000924

- Term: Anticholesteremic Agents

- ID: D000000960

- Term: Hypolipidemic Agents

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000057847

- Term: Lipid Regulating Agents

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M409

- Name: Ezetimibe

- Relevance: HIGH

- As Found: Amount

- ID: M21155

- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- Relevance: HIGH

- As Found: Genotype

- ID: M4243

- Name: Anticholesteremic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4278

- Name: Hypolipidemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M28883

- Name: Lipid Regulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069438

- Term: Ezetimibe

- ID: D000019161

- Term: Hydroxymethylglutaryl-CoA Reductase Inhibitors

### Misc Info Module

- Version Holder: 2024-05-24
