Acute Coronary SyndromePhase 4NCT02015988
Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome
A Phase 4 study testing Fenofibrate and Simvastatin in people with Acute Coronary Syndrome and Diabetes Mellitus, Type 2, run by Koval' O., MD at 1 site in Ukraine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Diabetes Mellitus, Type 2, Hypertriglyceridemia
- What is being tested?
- Fenofibrate and Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUkraine
- Study dates
- Jan 2014to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"
Dnipropetrovsk
About this study
Official title: Effectiveness and Tolerability of Early Initiation of Combined Lipid -Lowering Therapy Included Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus, Hypertriglyceridemia and Acute Coronary Syndrome
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.
- Being tested
- Fenofibrate, Simvastatin
- Keywords
- Acute coronary syndrome, Diabetes Mellitus, Type 2, Hypertriglyceridemia, Simvastatin, Fenofibrate
- Medical subject headings
- Acute Coronary Syndrome, Diabetes Mellitus, Type 2, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Also called Tricor
SimvastatinDrug
Also called Zocor-forte
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin and Fenofibrate | Experimental | Simvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year) Receives: Drug: Fenofibrate; Drug: Simvastatin |
| Simvastatin | Active comparator | Simvastatin 40 mg once daily orally for 52 weeks (1 year) Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in triglycerides (TG) at week 12
Measured: Baseline, Week 12
Secondary outcomes (12)
Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 12
Measured: Week 12
Percentage changes from baseline in apoB/apoA1 ratio at week 12
Measured: Baseline, Week 12
Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12
Measured: Baseline, Week 12
Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12
Measured: Baseline, Week 12
Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12
Measured: Baseline, Week 12
Percentage changes from baseline in uric acid at week 12
Measured: Baseline, Week 12
Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 52
Measured: Week 52
Percentage changes from baseline in apoB/apoA1 ratio at week 52
Measured: Baseline, Week 52
Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52
Measured: Baseline, Week 52
Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52
Measured: Baseline, Week 52
Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52
Measured: Baseline, Week 52
Percentage changes from baseline in uric acid at week 52
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koval' O., MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Koval' O., MD, Dnipropetrovsk State Medical Academy
- Investigators
- Olena A Koval', MD, PhD, Principal investigator, State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015988
- Sponsor's protocol ID
- A14-284
- Status last verified
- Aug 2016
- First submitted
- 14 Dec 2013
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of Early Initiation of Combined Lipid -Lowering Therapy Included Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus, Hypertriglyceridemia and Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02015988
- Acronym / sponsor ID
- A14-284
- Keywords
- Acute coronary syndrome, Diabetes Mellitus, Type 2, Hypertriglyceridemia, Simvastatin, Fenofibrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Koval' O., MDUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin and Fenofibrate | Experimental | Drug: Fenofibrate, Drug: SimvastatinSimvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year) |
| Simvastatin | Active comparator | Drug: SimvastatinSimvastatin 40 mg once daily orally for 52 weeks (1 year) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenofibrateAlso: Tricor | Drug | Simvastatin and Fenofibrate |
| SimvastatinAlso: Zocor-forte | Drug | Simvastatin, Simvastatin and Fenofibrate |
Primary outcome
Percentage change from baseline in triglycerides (TG) at week 12
Time frame: Baseline, Week 12
12 secondary outcomes
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
Percentage changes from baseline in apoB/apoA1 ratio at week 12
Time frame: Baseline, Week 12
Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12
Time frame: Baseline, Week 12
Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12
Time frame: Baseline, Week 12
Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12
Time frame: Baseline, Week 12
Percentage changes from baseline in uric acid at week 12
Time frame: Baseline, Week 12
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
Percentage changes from baseline in apoB/apoA1 ratio at week 52
Time frame: Baseline, Week 52
Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52
Time frame: Baseline, Week 52
Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52
Time frame: Baseline, Week 52
Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52
Time frame: Baseline, Week 52
Percentage changes from baseline in uric acid at week 52
Time frame: Baseline, Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olena A Koval', MD, PhD principal investigator
State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenofibrate and Simvastatin in people with Acute Coronary Syndrome and Diabetes Mellitus, Type 2, run by Koval' O., MD at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in triglycerides (TG) at week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.