Condition category
Circulatory System
Date applied
13/10/2003
Date assigned
13/10/2003
Last edited
08/08/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Solvay Pharmaceuticals GmbH (Germany)

Sponsor details

Hans-Boeckler Alee 20
Hannover
30173
Germany

Sponsor type

Industry

Website

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

  1. 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.

Additional files

Editorial Notes