Contact information
Type
Scientific
Primary contact
Dr Cornel Pater
ORCID ID
Contact details
An der Trift 18
Hannover
30559
Germany
+49 (0)511 857 2074
cornel.pater@solvay.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
S1853001
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effect of Omacor on time-domain heart rate variability (HRV) parameters in comparison to placebo in patients with recent uncomplicated transmural myocardial infarction.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
A randomised, parallel group, double-blind, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Myocardial infarction
Intervention
Based on the inclusion criteria, a first 24-hour Holter recording will be performed. Two to five days later, screened patients still eligible for the study will undergo a second 24-hour Holter recording. After the second Holter recording, all patients will be randomly allocated to treatment with Omacor 1 g once daily (o.d.) or placebo o.d.
Patients will be followed-up in double-blind fashion for a six-month period after randomisation. Visits, including 24-hour Holter recording and assessment of adverse events, will take place at one-month intervals ± five days after randomisation, i.e., six times in all.
Intervention type
Drug
Phase
Not Specified
Drug names
Omacor
Primary outcome measures
Superiority of Omacor to improve HRV from baseline to endpoint.
Secondary outcome measures
1. Improvement in time domain HRV indices
2. Safety
Overall trial start date
01/01/2004
Overall trial end date
01/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males and females aged 40 years or older
2. Recent sustained acute myocardial infarction (AMI)
3. Women of childbearing age are subject to pregnancy testing and must agree to maintain adequate hormonal contraception
4. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Clinically or hemodynamically unstable condition
2. Further invasive investigation, a percutaneous transluminal coronary angioplasty (PTCA) or a coronary atrery bypass graft (CABG) are required
3. Sustained antiarrhythmic therapy (other than a beta-blocking agent administered in the context of secondary prevention of MI)
4. Severe concomitant illness (related to any body organ or system) that is likely to affect outcome assessment
5. Compliance problems
6. Participating in another trial within the past 30 days
7. Pregnant or lactating
8. Known hypersensitivity to the ingredients in Omacor or intolerability to olive oil
9. Diabetes mellitus type I and II
Recruitment start date
01/01/2004
Recruitment end date
01/01/2005
Locations
Countries of recruitment
Lithuania, Poland
Trial participating centre
An der Trift 18
Hannover
30559
Germany
Funders
Funder type
Industry
Funder name
Solvay Pharmaceuticals GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Protocol in: http://www.ncbi.nlm.nih.gov/pubmed/14613518
Publication citations
-
Protocol
Pater C, Compagnone D, Luszick J, Verboom CN, Effect of Omacor on HRV parameters in patients with recent uncomplicated myocardial infarction - A randomized, parallel group, double-blind, placebo-controlled trial: study design [ISRCTN75358739]., Curr Control Trials Cardiovasc Med, 2003, 4, 1, 2, doi: 10.1186/1468-6708-4-2.