NCT03277079

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

September 6, 2017

Last Update Submit

September 6, 2017

Conditions

Coronary Artery Disease

Keywords

coronary artery diseaseLDL cholesteroltherapeutic target

Outcome Measures

Primary Outcomes (1)

  • Therapeutic target

    LDL cholesterol \< 70 mg/dl

    Up to 3 months

Study Arms (2)

statin + ezetimibe

ACTIVE COMPARATOR

Low dose statin associated with ezetimibe

Drug: statin + ezetimibeDrug: statin + ezetimibe + Nutraceuticals

statin + ezetimibe + Nutraceuticals

ACTIVE COMPARATOR

Low dose statin associated with ezetimibe and Nutraceuticals

Drug: statin + ezetimibeDrug: statin + ezetimibe + Nutraceuticals

Interventions

statin + ezetimibeDRUG

Combination of two drugs

Also known as: Anticholesterol drug
statin + ezetimibestatin + ezetimibe + Nutraceuticals
statin + ezetimibe + NutraceuticalsDRUG

Combination of two grus plus nutraceuticals

Also known as: Anticholesterol drug
statin + ezetimibestatin + ezetimibe + Nutraceuticals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with angiographically assessed diagnosis of coronary artery disease

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza University

Rome, 00161, Italy

Location

Related Publications (1)

  • 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: 30420184DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Hydroxymethylglutaryl-CoA Reductase InhibitorsEzetimibeDietary Supplements

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic UsesAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Carlo Gaudio, MD

    Sapienza University

    STUDY CHAIR

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

39064997f.pelliccia@mclink.it

Giuseppe Marazzi, MD

CONTACT

39064997marazzig@gmai.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 8, 2017

Study Start

October 1, 2017

Primary Completion

December 31, 2017

Study Completion

March 31, 2018

Last Updated

September 8, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)