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Status unknownNCT02015988Updated Aug 4, 2016

Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome

A Phase 4 interventional study of Fenofibrate and Simvastatin in Acute Coronary Syndrome, Diabetes Mellitus, Type 2 and Hypertriglyceridemia, sponsored by Koval' O., MD. Status unknown at 1 site in Ukraine. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-04.

Sponsored by Koval' O., MD · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To test the hypothesis that early (within 5-21 days after index event) administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG with diabetes.

Read the detailed description

The primary objective of this parallel group study is to demonstrate that the combined therapy of simvastatin and fenofibrate is superior compared to monotherapy with simvastatin based on the comparisons of change of TG levels after 12 weeks of treatment compared to baseline.

Secondary objectives are to compare both treatment alternatives the combination therapy of simvastatin and fenofibrate to simvastatin monotherapy with respect to achievement the European Society of Cardiology 2011 (ESC 2011) non-HDL-C target (less than 2,6 mmol/l), change of apolipoprotein B/apolipoprotein A1 (apoB/apoA1) ratio, High-Density Lipoprotein-Cholesterol (HDL-C), Low-Density Lipoprotein-Cholesterol (LDL-C) and Uric Acid (UA) after 12 weeks and 52 weeks (1 year) of treatment compared to baseline.

02

Conditions studied

  • Acute Coronary Syndrome
  • Diabetes Mellitus, Type 2
  • Hypertriglyceridemia

Keywords

  • Acute coronary syndrome
  • Diabetes Mellitus, Type 2
  • Hypertriglyceridemia
  • Simvastatin
  • Fenofibrate
03

In context

Acute Coronary Syndrome

1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 880 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

This is the only study on the registry with Koval' O., MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type 2 Diabetes Mellitus
  • Fasting triglycerides ≥ 1,7 mmol/l
  • Acute coronary syndrome at least before 5 and maximum 21 days before the inclusion
  • If previously treated with statin therapy, the dose should be equivalent to 40 mg of simvastatin at inclusion
  • In case of previous statin therapy, last LDL-C measurement before event should be ≤ 2,6 mmol/l
  • Written informed consent obtained

Exclusion criteria

Exclusion Criteria:

  • Heart failure IV class (NYHA)
  • Acute decompensated heart failure
  • Life expectancy no more than 1 year
  • Chronic kidney disease (CKD) with Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
  • Severe chronic liver diseases with Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 3 Upper Limit of Normal (ULN)
  • Known gallbladder disease, including cholecystolithiasis
  • Creatinphosphokinase (CPK) > 5 ULN at baseline
  • Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia
  • Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen,
  • Known allergy to peanut or arachis oil or soya lecithin or related products
  • Hypersensitivity to simvastatin or fenofibrate or to any of the excipients of the investigational drugs
  • Concomitant administration of potent cytochrome P450 isoenzyme 3A4 inhibitors (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone)
  • Pregnancy and lactation
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Simvastatin and Fenofibrate

    Simvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year)

    Drug: Fenofibrate · Drug: Simvastatin

  • Active comparator
    Simvastatin

    Simvastatin 40 mg once daily orally for 52 weeks (1 year)

    Drug: Simvastatin

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage change from baseline in triglycerides (TG) at week 12

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 12

    Time frame: Week 12

  2. Percentage changes from baseline in apoB/apoA1 ratio at week 12

    Time frame: Baseline, Week 12

  3. Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12

    Time frame: Baseline, Week 12

  4. Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12

    Time frame: Baseline, Week 12

  5. Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12

    Time frame: Baseline, Week 12

  6. Percentage changes from baseline in uric acid at week 12

    Time frame: Baseline, Week 12

  7. Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 52

    Time frame: Week 52

  8. Percentage changes from baseline in apoB/apoA1 ratio at week 52

    Time frame: Baseline, Week 52

  9. Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52

    Time frame: Baseline, Week 52

  10. Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52

    Time frame: Baseline, Week 52

  11. Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52

    Time frame: Baseline, Week 52

  12. Percentage changes from baseline in uric acid at week 52

    Time frame: Baseline, Week 52

Other outcomes

  1. Number of adverse events (AE) caused discontinuations of investigational products

    Time frame: Up to 52 week

07

Study locations

1 site
  • State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"
    Dnipropetrovsk, Ukraine
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02015988
Lead sponsor
Koval' O., MD
Responsible party
Koval' O., MD (PhD, Professor, Dnipropetrovsk State Medical Academy) — Sponsor-investigator
First posted
Dec 19, 2013
Start date
Jan 2014
Primary completion
Sep 2016 (estimated)
Completion
May 2017 (estimated)
Last update
Aug 4, 2016

Study contacts

Olena A Koval', MD, PhD
principal investigator · State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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