Clinical Trial Results:
EFFEKTEN AF EZETIMIBE SOM TILLÆG TIL OPTIMAL STATINBEHANDLING PÅ PLAQUE-KOMPOSITIONEN HOS PATIENTER MED AKUT MYOKARDIEINFARKT - VURDERET MED OPTICAL COHERENCE TOMOGRAPHY OG INTRAVASKULÆR ULTRALYD (OCTIVUS)
Summary
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EudraCT number |
2010-022604-45 |
Trial protocol |
DK |
Global end of trial date |
20 Jun 2014
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Results information
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Results version number |
v2(current) |
This version publication date |
25 Jun 2021
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First version publication date |
05 Jun 2015
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Other versions |
v1 (removed from public view) |
Version creation reason |
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Summary report(s) |
OCTIVUS Thesis |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
46908990
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01385631 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
Sdr. Boulevard 29, Odense C, Denmark, 5000
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Public contact |
Same as organisation, Dr. Henrik Steen Hansen
Odense University Hospital, Department of Cardiology, 45 21955161, Henrik.Steen.Hansen@rsyd.dk
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Scientific contact |
Same as organisation, Dr. Henrik Steen Hansen
Odense University Hospital, Department of Cardiology, 45 21955161, Henrik.Steen.Hansen@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Mar 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Jun 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine whether Ezetimibe 10 mg per day in addition to Atorvastin 80 mg per day results in further plaque regression and to assess changes in plaque composition.
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Protection of trial subjects |
Patients were followed with clinical evaluation and safety blood samples after 1, 3, and 6 months to assess possible adverse events and compliance.
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Background therapy |
Atorvastatin 80 mg per day | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Jun 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 87
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Worldwide total number of subjects |
87
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EEA total number of subjects |
87
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
64
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From 65 to 84 years |
23
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85 years and over |
0
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Recruitment
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Recruitment details |
Eligible for recruitment were patients with first time ST segment myocardial infarction (STEMI) not previously treated with cholesterol lowering drugs. Patients were required to be >18 and <81 years and able to provide written consent. For further details see the attached thesis (pdf). | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Main inclusion criteria was first time STEMI, and main exclusion criterias were ongoing lipid lowering therapy, age >80, concommittant disease and use of another drug eluting stent than the one designated by the study protocol (Resolute Integrity, St. Jude Medical). | ||||||||||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
87 | ||||||||||||||||||||||||
Number of subjects completed |
87 | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Assessor | ||||||||||||||||||||||||
Blinding implementation details |
Assignment to treatment arms was randomized by the hospital pharmacy and study medication was derived as blinded capsules. Patient data were achieved with randomized study-ID numbers associated with the patient-ID in a key-file not accessible to the investigator. The analyst was blinded for patient ID and baseline-follow-up sequence during assessment.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention arm | ||||||||||||||||||||||||
Arm description |
Patients assigned to the intervention arm were treated with atorvastatin 80 mg AND ezetimibe 10 mg. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
ezetimibe
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg per day
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Investigational medicinal product name |
Aorvastatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
80 mg per day
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Arm title
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Placebo | ||||||||||||||||||||||||
Arm description |
Patients treated with atorvastin 80 mg AND placebo | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
N/A
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Investigational medicinal product name |
Atorvastatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
80 mg per day
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End points reporting groups
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Reporting group title |
Intervention arm
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Reporting group description |
Patients assigned to the intervention arm were treated with atorvastatin 80 mg AND ezetimibe 10 mg. | ||
Reporting group title |
Placebo
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Reporting group description |
Patients treated with atorvastin 80 mg AND placebo |
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End point title |
Change in necrotic core | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 months
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Notes [1] - Change in most disesed 10 mm segment [2] - Change in 10 mm most diseased segment |
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Statistical analysis title |
Change from baseline | ||||||||||||
Comparison groups |
Intervention arm v Placebo
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Number of subjects included in analysis |
77
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
12 months
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
Annual safety report | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
N/A
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Reporting groups
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Reporting group title |
SAE and AE
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |