Low Dose Statins, Ezetimibe and Nutraceuticals

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: statin + ezetimibe; Drug: statin + ezetimibe + Nutraceuticals

• Registration Number: NCT03277079
• Lead Sponsor: University of Roma La Sapienza

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

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-06
• Last Update Submitted: 2017-09-06
• Study First Posted: 2017-09-08
• Last Update Posted: 2017-09-08
• Study Start: 2017-10-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with angiographically assessed diagnosis of coronary artery disease

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
statin + ezetimibe	statin + ezetimibe	Low dose statin associated with ezetimibe
statin + ezetimibe	statin + ezetimibe + Nutraceuticals	Low dose statin associated with ezetimibe
statin + ezetimibe + Nutraceuticals	statin + ezetimibe	Low dose statin associated with ezetimibe and Nutraceuticals
statin + ezetimibe + Nutraceuticals	statin + ezetimibe + Nutraceuticals	Low dose statin associated with ezetimibe and Nutraceuticals

Primary Outcome Measures

Name	Time	Method
Therapeutic target	Up to 3 months	LDL cholesterol \< 70 mg/dl

Trial Locations

Locations (1)

Sapienza University; 🇮🇹 Rome, Italy