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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03277079
Other study ID # 123/D/2017
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received September 6, 2017
Last updated September 6, 2017
Start date October 1, 2017
Est. completion date March 31, 2018

Study information

Verified date September 2017
Source University of Roma La Sapienza
Contact Francesco Pelliccia, MD
Phone 39064997
Email f.pelliccia@mclink.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients with angiographically assessed diagnosis of coronary artery disease

Exclusion Criteria:

Study Design


Intervention

Drug:
statin + ezetimibe
Combination of two drugs
statin + ezetimibe + Nutraceuticals
Combination of two grus plus nutraceuticals

Locations

Country Name City State
Italy Sapienza University Rome

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic target LDL cholesterol < 70 mg/dl Up to 3 months
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