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The Effects of Lovaza® in Acute Myocardial Infarction (OmegaMI)

This study has been terminated.
(Only 5 individuals were able to be recruited.)
Sponsor:
Collaborators:
GlaxoSmithKline
Albany College of Pharmacy and Health Sciences
Information provided by (Responsible Party):
Robert Block, University of Rochester
ClinicalTrials.gov Identifier:
NCT01155336
First received: June 25, 2010
Last updated: March 8, 2013
Last verified: March 2013
Results First Received: February 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Myocardial Infarction
Interventions: Drug: Lovaza®
Drug: The placebo contained 1 gram of corn oil in each capsule.

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Corn Oil

The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.

The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill

Lovaza®

Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.

Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement.


Participant Flow:   Overall Study
    Corn Oil     Lovaza®  
STARTED     0 [1]   4 [1]
COMPLETED     0 [1]   4 [1]
NOT COMPLETED     0     0  
[1] We did not complete the study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Corn Oil

The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.

The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill

Lovaza®

Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.

Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement.

Total Total of all reporting groups

Baseline Measures
    Corn Oil     Lovaza®     Total  
Number of Participants  
[units: participants]
  0     4     4  
Age  
[units: participants]
     
<=18 years         0     0  
Between 18 and 65 years         3     3  
>=65 years         1     1  
Age  
[units: years]
Mean ± Standard Deviation
      60.25  ± 10     60.25  ± 10  
Gender  
[units: participants]
     
Female         1     1  
Male         3     3  
Region of Enrollment  
[units: participants]
     
United States         4     4  



  Outcome Measures

1.  Primary:   Platelet Function   [ Time Frame: 12 hours ]

2.  Secondary:   Cardiac Electrophysiology   [ Time Frame: 1 week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
no adverse events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Robert Block
Organization: University of Rochester
phone: 585 275-3356
e-mail: robert_block@urmc.rochester.edu


No publications provided


Responsible Party: Robert Block, University of Rochester
ClinicalTrials.gov Identifier: NCT01155336     History of Changes
Other Study ID Numbers: LVZ114193
Study First Received: June 25, 2010
Results First Received: February 5, 2013
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board