Trial Outcomes & Findings for The Effects of Omega-3 Fatty Acids on Aspirin Resistance (NCT NCT00771914)

NCT ID: NCT00771914

Last Updated: 2012-11-06

Results Overview

The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2012-11-06

Participant Flow

Participant milestones

Measure	Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza	Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo First 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza, then 4 grams of Lovaza, then 81mg of Aspirin	Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81 mg of Aspirin	Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
Overall Study STARTED	7	6	6	8
Overall Study COMPLETED	7	6	6	6
Overall Study NOT COMPLETED	0	0	0	2

Reasons for withdrawal

Measure	Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza	Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo First 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza, then 4 grams of Lovaza, then 81mg of Aspirin	Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81 mg of Aspirin	Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
Overall Study Physician Decision	0	0	0	1
Overall Study Lost to Follow-up	0	0	0	1

Baseline Characteristics

The Effects of Omega-3 Fatty Acids on Aspirin Resistance

Baseline characteristics by cohort

Measure	Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza n=7 Participants First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza	Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo n=6 Participants First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo	Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin n=6 Participants First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin	Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin n=8 Participants First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	27 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	29.7 years STANDARD_DEVIATION 9.7 • n=5 Participants	32.9 years STANDARD_DEVIATION 11.6 • n=7 Participants	25.9 years STANDARD_DEVIATION 3.4 • n=5 Participants	29.3 years STANDARD_DEVIATION 10.2 • n=4 Participants	29.3 years STANDARD_DEVIATION 9.1 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	8 participants n=4 Participants	27 participants n=21 Participants

PRIMARY outcome

Timeframe: 4 hours

Population: Each participant acted as own control since each received the intervention (placebo, aspirin, lovaza, and both aspirin and lovaza) and had these effects compared to baseline (four hour effect of each intervention).

The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.

Outcome measures

Measure	Placebo n=25 Participants All participants received Placebo intervention regardless of sequence.	Aspirin n=25 Participants All participants received Aspirin intervention regardless of sequence.	Lovaza n=25 Participants All participants received Lovaza intervention regardless of sequence.	Both Aspirin and Lovaza n=25 Participants All participants received Aspirin and Lovaza intervention regardless of sequence.
the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment	0.0 seconds Standard Deviation 30	10.9 seconds Standard Deviation 50.23	-6.5 seconds Standard Deviation 63.6	30.5 seconds Standard Deviation 60.3

Adverse Events

Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza n=7 participants at risk First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza	Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo n=6 participants at risk First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo	Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin n=6 participants at risk First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin	Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin n=6 participants at risk First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
Surgical and medical procedures Headache, nausea, lightheadness	0.00% 0/7	0.00% 0/6	0.00% 0/6	16.7% 1/6 • Number of events 1

Additional Information

Robert Block, MD, MPH, FACP

University of Rochester Division of Epidemiology, Department of Community and Preventive Medicine

Phone: 585-275-3356

Email: robert_block@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place