NCT02125682

Brief Summary

Atorvastatin is a statin that significantly decreases LDL level. At 10 mg/day, atorvastatin increases HDL level by 4-5%. At 80 mg/day, atorvastatin does not increase HDL level. However, atorvastatin is more protective at 80 mg/day than at 10 mg/day. This is due to a better reduction in LDL level at 80 mg, but we also think that 80 mg/day of atorvastatin is superior to 10 mg/day in improving the QUALITY of HDL, such as improving HDL particle number and function (better anti-oxydant activity)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

5.4 years

First QC Date

April 27, 2014

Last Update Submit

January 30, 2018

Conditions

Dyslipidemia in Patients With Diabetes Mellitus

Keywords

HDLHyperlipidemiaDiabetesInflammation

Outcome Measures

Primary Outcomes (1)

  • effect on HDL function

    Does atorvastatin 80 mg/day improve HDL function more than 10 mg/day. HDL function will be assessed via several tests

    8 weeks

Study Arms (2)

low dose

ACTIVE COMPARATOR

patients receiving 10 mg of atorvastatin daily

Drug: atovastatin 10 mg/day

High dose

ACTIVE COMPARATOR

Patients receiving 80 mg of atorvastatin daily

Drug: Atorvastatin 80 mg/day

Interventions

atovastatin 10 mg/dayDRUG

patients will receive 10 mg of atorvastatin daily for 8 weeks, then wash out for 6 weeks then cross over to atorvastatin 80 mg daily for 8 weeks

low dose
Atorvastatin 80 mg/dayDRUG

patients will receive 80 mg of atorvastatin daily for 8 weeks, then wash out for 6 weeks then cross over to atorvastatin 10 mg daily for 8 weeks

High dose

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with diabetes mellitus, defined by at least 1 of the following:
  • Fasting glucose \> 125 mg/dL confirmed on 2 occasions HbA1C \> 6.5% Patients receiving any glucose lowering agent (oral or subcutaneous)
  • Lipid profile should have ALL of the following characteristics:
  • Triglycerides \>150 mg/dL HDL \<45 mg/dL LDL \< 190 mg/dL
  • Lp(a) level \< 30 mg/dL

You may not qualify if:

  • Patients with known coronary artery disease defined by at least one of the following:
  • Prior myocardial infarction
  • Prior PCI
  • Prior CABG
  • Known coronary stenosis \> 50% on coronary angiography
  • A non invasive study revealing myocardial ischemia (such as a stress test, a nuclear perfusion study or a stress echo)
  • Poor diabetic control defined by an HbA1c \> 8.5% in the preceding 3 months
  • Patients with known diabetic retinopathy, nephropathy or neuropathy
  • Patients with a creatinin clearance \< 75 ml/min as calculated by the Cockcroft-Gault equation
  • Patients with underlying malignancy or infection or inflammatory disease
  • Patients with SGPT or SGOT or CK \> 2.5 times upper reference value
  • Patients allergic to statins or who experienced prior significant side effects with statins such as elevation of liver enzymes or CK \> 2.5 upper reference value
  • Patients older than 80
  • Females who are premenopausal
  • Patients unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu de France Hospital

Beirut, Beirut, Lebanon

Location

MeSH Terms

Conditions

HyperlipidemiasDiabetes MellitusInflammation

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • M. John Chapman, PhD

    INSERM Pitié Salpetriere, Paris, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiology, Hotel Dieu de France Hospital

Study Record Dates

First Submitted

April 27, 2014

First Posted

April 29, 2014

Study Start

January 1, 2012

Primary Completion

May 14, 2017

Study Completion

May 14, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

LE(1)