Trial Outcomes & Findings for The Effects of Lovaza® in Acute Myocardial Infarction (NCT NCT01155336)

Results Overview

Platelet function will be measured with PFA-100 test which has been shown to correlate with an increased risk for cardiovascular events in several well conducted studies and in a meta-analysis. The PFA-100 measures the number of seconds required for a clot to form in whole blood which is passed through an aperture in a cartridge coated with epinephrine. It is meant to imitate clotting in human arteries.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

12 hours

Results posted on

2017-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	0	4
Overall Study COMPLETED	0	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Lovaza® in Acute Myocardial Infarction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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® n=4 Participants 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 n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	3 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	—	60.25 years STANDARD_DEVIATION 10 • n=7 Participants	60.25 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	—	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	—	4 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

Population: We did not complete the study and no subjects were randomized to corn oil

Platelet function will be measured with PFA-100 test which has been shown to correlate with an increased risk for cardiovascular events in several well conducted studies and in a meta-analysis. The PFA-100 measures the number of seconds required for a clot to form in whole blood which is passed through an aperture in a cartridge coated with epinephrine. It is meant to imitate clotting in human arteries.

Outcome measures

Outcome measures
Measure	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® n=4 Participants 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.
Platelet Function	—	130.25 seconds Interval 101.0 to 190.0

SECONDARY outcome

Timeframe: 1 week

Population: Data was not collected for this outcome measure.

A 20-minute supine 12-lead Holter ECG will allow the quantification of a series of standard ECG parameters as well as provide insight into frequency-domain HRV parameters, QRS duration and morphology, using signal-averaged ECG (SAECG), repolarization morphology, and variability utilizing specialized programs.

Outcome measures

Outcome data not reported

Adverse Events

Corn Oil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lovaza®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Block

University of Rochester

Phone: 585 275-3356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place