Low Dose Statins, Ezetimibe and Nutraceuticals

NCT ID: NCT03277079

Last Updated: 2017-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-03-31

Brief Summary

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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

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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

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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statin + ezetimibe

Low dose statin associated with ezetimibe

Group Type ACTIVE_COMPARATOR

statin + ezetimibe

Intervention Type DRUG

Combination of two drugs

statin + ezetimibe + Nutraceuticals

Intervention Type DRUG

Combination of two grus plus nutraceuticals

statin + ezetimibe + Nutraceuticals

Low dose statin associated with ezetimibe and Nutraceuticals

Group Type ACTIVE_COMPARATOR

statin + ezetimibe

Intervention Type DRUG

Combination of two drugs

statin + ezetimibe + Nutraceuticals

Intervention Type DRUG

Combination of two grus plus nutraceuticals

Interventions

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statin + ezetimibe

Combination of two drugs

Intervention Type DRUG

statin + ezetimibe + Nutraceuticals

Combination of two grus plus nutraceuticals

Intervention Type DRUG

Other Intervention Names

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Anticholesterol drug Anticholesterol drug

Eligibility Criteria

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Inclusion Criteria

Patients with angiographically assessed diagnosis of coronary artery disease

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Pelliccia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Gaudio, MD

Role: STUDY_CHAIR

Sapienza University

Locations

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Sapienza University

Rome, , Italy

Site Status

Countries

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Italy

Central Contacts

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Francesco Pelliccia, MD

Role: CONTACT

39064997 ext. 123

Giuseppe Marazzi, MD

Role: CONTACT

39064997 ext. 456

References

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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.

Reference Type DERIVED
PMID: 30420184 (View on PubMed)

Other Identifiers

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123/D/2017

Identifier Type: -

Identifier Source: org_study_id

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