Trial Outcomes & Findings for Lovaza's Effect on the Activation of Platelets (NCT NCT00515541)
NCT ID: NCT00515541
Last Updated: 2013-07-09
Results Overview
The PAP-8E measures platelet aggregation in platelet rich plasma (PRP). Platelet responses to a series of common agonists cause changes in optical density that are measured. The instrument is blanked (100% baseline (optimal transmission)) by inserting a platelet poor plasma (PPP) specimen into the appropriate channel. The PRP is then inserted into the same well. The difference in optical density between the PPP and the PRP 0% baseline (optical transmission) is recorded for several minutes when the agonist reagent is added to the PRP.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
up to and including closeout at 24 weeks
Results posted on
2013-07-09
Participant Flow
The study was conducted at the Carolina Center for Clinical Trials at the University of North Carolina at Chapel Hill campus. Enrollment period: 9/24/07 through 10/13/08.
Participant milestones
| Measure |
Group A: Subjects on Lovaza Only
Group A: Subject is healthly and not on Aspirin, Clopidogrel, or Warfarin. Subjects will be taking escalating doses of the study drug (Lovaza)up to 24 weeks.
|
Group B: Subjects on Lovaza Plus Aspirin
Group B: Subject is only taking Aspirin (\< or = 325mg) daily. Subjects will be taking escalating doses of study drug (Lovaza) in addition to aspirin up to 24 weeks.
|
Group C: Subjects on Lovaza Plus Clopidogrel and Aspirin
Subject is regularly taking Clopidogrel (75mg)and Aspirin (\< or = 325mg)daily, and not taking Warfarin. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Clopidogrel and Aspirin up to 24 weeks.
|
Group D: Subjects on Lovaza Plus Warfarin and Aspirin
Subject is regularly taking Warfarin and Aspirin (\< or = 325mg)daily, and not taking Clopidogrel. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Warfarin and Aspirin up to 24 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
10
|
11
|
|
Overall Study
6 Weeks (1 gm Lovaza)
|
10
|
10
|
10
|
10
|
|
Overall Study
12 Weeks (2 gm Lovaza)
|
10
|
10
|
10
|
10
|
|
Overall Study
18 Weeks (4 gm Lovaza)
|
10
|
9
|
10
|
9
|
|
Overall Study
24 Weeks (8 gm Lovaza)
|
10
|
7
|
10
|
6
|
|
Overall Study
COMPLETED
|
10
|
7
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
0
|
5
|
Reasons for withdrawal
| Measure |
Group A: Subjects on Lovaza Only
Group A: Subject is healthly and not on Aspirin, Clopidogrel, or Warfarin. Subjects will be taking escalating doses of the study drug (Lovaza)up to 24 weeks.
|
Group B: Subjects on Lovaza Plus Aspirin
Group B: Subject is only taking Aspirin (\< or = 325mg) daily. Subjects will be taking escalating doses of study drug (Lovaza) in addition to aspirin up to 24 weeks.
|
Group C: Subjects on Lovaza Plus Clopidogrel and Aspirin
Subject is regularly taking Clopidogrel (75mg)and Aspirin (\< or = 325mg)daily, and not taking Warfarin. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Clopidogrel and Aspirin up to 24 weeks.
|
Group D: Subjects on Lovaza Plus Warfarin and Aspirin
Subject is regularly taking Warfarin and Aspirin (\< or = 325mg)daily, and not taking Clopidogrel. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Warfarin and Aspirin up to 24 weeks.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
1
|
|
Overall Study
No show for appointments
|
0
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
2
|
Baseline Characteristics
Lovaza's Effect on the Activation of Platelets
Baseline characteristics by cohort
| Measure |
Group A: Subject on Lovaza Only
n=10 Participants
Group A: Subject is not on Aspirin, Clopidogrel, or Warfarin. Subject is taking escalating doses of study drug (Lovaza)over a 24 week period.
|
Group. B: Subject on Lovaza + Aspirin
n=12 Participants
Group B: Subject on Aspirin (\< or = 325mg and is not taking Clopidogrel or Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
|
Group C: Subject on Lovaza + Clopidogrel + Aspirin
n=10 Participants
Group C: Subject is taking Clopidogrel 75mg)and Aspirin (\< or = 325mg) and not taking Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
|
Group D: Subject on Lovaza + Warfarin + Aspirin
n=11 Participants
Group D: Subject is taking Warfarin and Aspirin (\< or = 325mg)and is not taking Clopidogrel. Subject is taking escalating doses of Lovaza over a 24 week period.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Gender
Female
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
NA participants
n=7 Participants
|
12 participants
n=31 Participants
|
|
Gender
Male
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
5 participants
n=206 Participants
|
NA participants
n=7 Participants
|
20 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
10 participants
n=206 Participants
|
11 participants
n=7 Participants
|
43 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: up to and including closeout at 24 weeksPopulation: Based on number of subjects completing 24 weeks
The PAP-8E measures platelet aggregation in platelet rich plasma (PRP). Platelet responses to a series of common agonists cause changes in optical density that are measured. The instrument is blanked (100% baseline (optimal transmission)) by inserting a platelet poor plasma (PPP) specimen into the appropriate channel. The PRP is then inserted into the same well. The difference in optical density between the PPP and the PRP 0% baseline (optical transmission) is recorded for several minutes when the agonist reagent is added to the PRP.
Outcome measures
| Measure |
Group A: Subject on Lovaza Only
n=10 Participants
Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group B: Subject on Lovaza + Aspirin
n=7 Participants
Group B: Subject on study drug (Lovaza) plus Aspirin (\< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group C: Subject on Lovaza + Clopidogrel + Aspirin
n=10 Participants
Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (\< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group D: Subject on Lovaza + Warfarin + Aspirin
n=6 Participants
Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (\< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
|
|---|---|---|---|---|
|
Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)
Baseline (Week 0)
|
79.5 percent
Interval 36.0 to 100.0
|
0 percent
Interval 0.0 to 49.0
|
5.5 percent
Interval 2.0 to 10.0
|
8 percent
Interval 2.0 to 27.0
|
|
Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)
1 gram Lovaza Daily (Week 6)
|
79.5 percent
Interval 73.0 to 100.0
|
3 percent
Interval 0.0 to 8.0
|
6.5 percent
Interval 2.0 to 15.0
|
9 percent
Interval 3.0 to 58.0
|
|
Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)
2 grams Lovaza Daily (Week 12)
|
87.5 percent
Interval 35.0 to 93.0
|
2.5 percent
Interval 0.0 to 7.0
|
6 percent
Interval 3.0 to 10.0
|
12 percent
Interval 7.0 to 24.0
|
|
Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)
4 grams Lovaza Daily (Week 18)
|
82 percent
Interval 47.0 to 82.0
|
0 percent
Interval 0.0 to 2.0
|
4 percent
Interval 2.0 to 8.0
|
10 percent
Interval 6.0 to 18.0
|
|
Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)
8 grams Lovaza Daily (Week 24)
|
83 percent
Interval 80.0 to 85.0
|
3 percent
Interval 0.0 to 85.0
|
5 percent
Interval 1.0 to 14.0
|
22 percent
Interval 14.0 to 45.0
|
PRIMARY outcome
Timeframe: up to and including closeout at 24 weeksPopulation: Based on number of subjects completing 24 weeks
Bleeding time is a measure of how well platelets interact with blood vessel walls to form a clot. A manual blood pressure cuff is placed 2 inches above the antecubital fossa and inflated to 40mmHg. Using a standard Surgicutt device, a small incision is made and a stopwatch is started. The incision edge is blotted at 30 second intervals with standard filter paper until the bleeding has stopped. The time to hemostasis is noted.
Outcome measures
| Measure |
Group A: Subject on Lovaza Only
n=10 Participants
Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group B: Subject on Lovaza + Aspirin
n=7 Participants
Group B: Subject on study drug (Lovaza) plus Aspirin (\< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group C: Subject on Lovaza + Clopidogrel + Aspirin
n=10 Participants
Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (\< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group D: Subject on Lovaza + Warfarin + Aspirin
n=6 Participants
Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (\< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
|
|---|---|---|---|---|
|
Bleeding Time
Baseline (Week 0)
|
150 seconds
Interval 120.0 to 180.0
|
240 seconds
Interval 210.0 to 330.0
|
570 seconds
Interval 440.0 to 720.0
|
240 seconds
Interval 195.0 to 330.0
|
|
Bleeding Time
1 gram Lovaza Daily (Week 6)
|
240 seconds
Interval 180.0 to 300.0
|
345 seconds
Interval 240.0 to 450.0
|
720 seconds
Interval 450.0 to 720.0
|
285 seconds
Interval 218.0 to 323.0
|
|
Bleeding Time
2 grams Lovaza Daily (Week 12)
|
240 seconds
Interval 180.0 to 270.0
|
390 seconds
Interval 330.0 to 450.0
|
690 seconds
Interval 540.0 to 720.0
|
285 seconds
Interval 188.0 to 330.0
|
|
Bleeding Time
4 grams Lovaza Daily (Week 18)
|
255 seconds
Interval 180.0 to 270.0
|
330 seconds
Interval 300.0 to 420.0
|
600 seconds
Interval 360.0 to 780.0
|
240 seconds
Interval 210.0 to 300.0
|
|
Bleeding Time
8 grams Lovaza Daily (Week 24)
|
255 seconds
Interval 210.0 to 300.0
|
360 seconds
Interval 330.0 to 420.0
|
600 seconds
Interval 60.0 to 720.0
|
270 seconds
Interval 195.0 to 323.0
|
PRIMARY outcome
Timeframe: up to and including closeout at 24 weeksPopulation: Based on number of subjects completing 24 weeks. Change in EQELS value after the addition of Arachidonic Acid.
Measurements were made using a modified device (EQELS) to specifications of constant current, high electric field and a scattering angle of 30 degrees. EQELS provides a sensitive assessment of subtle changes in the cell surface that occurs with activation, ligand binding or apoptosis. These changes are the result of different distributions of charged groups that define a surface charge finger print for the current state of activation of the cell. Resting state platelets have a negative surface charge, whereas fully activated platelets have a positive surface charge.
Outcome measures
| Measure |
Group A: Subject on Lovaza Only
n=10 Participants
Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group B: Subject on Lovaza + Aspirin
n=7 Participants
Group B: Subject on study drug (Lovaza) plus Aspirin (\< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group C: Subject on Lovaza + Clopidogrel + Aspirin
n=10 Participants
Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (\< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group D: Subject on Lovaza + Warfarin + Aspirin
n=6 Participants
Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (\< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
|
|---|---|---|---|---|
|
EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid
Baseline (Week 0)
|
0.28 mobility units
Interval -0.08 to 1.85
|
-0.04 mobility units
Interval -1.38 to 0.39
|
-1.04 mobility units
Interval -1.26 to -0.89
|
-1.10 mobility units
Interval -1.19 to -0.03
|
|
EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid
1 gram Lovaza Daily (Week 6)
|
-0.45 mobility units
Interval -0.93 to 0.18
|
-0.72 mobility units
Interval -1.03 to -0.37
|
-0.73 mobility units
Interval -1.09 to 0.56
|
-0.50 mobility units
Interval -0.79 to 0.09
|
|
EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid
2 grams Lovaza Daily (Week 12)
|
-0.95 mobility units
Interval -1.11 to -0.55
|
-1.30 mobility units
Interval -1.62 to -1.17
|
-1.29 mobility units
Interval -1.4 to -1.05
|
-0.58 mobility units
Interval -1.01 to 0.27
|
|
EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid
4 grams Lovaza Daily (Week 18)
|
-1.08 mobility units
Interval -1.39 to -0.99
|
-0.94 mobility units
Interval -1.11 to -0.89
|
-1.14 mobility units
Interval -1.29 to -0.94
|
-0.44 mobility units
Interval -1.91 to 0.76
|
|
EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid
8 grams Lovaza Daily (Week 24)
|
-0.88 mobility units
Interval -1.15 to -0.8
|
-0.97 mobility units
Interval -1.09 to -0.83
|
-0.89 mobility units
Interval -1.31 to -0.8
|
-0.19 mobility units
Interval -0.76 to 0.26
|
SECONDARY outcome
Timeframe: up to and including closeout at 24 weeksPopulation: Subjects would indicate if they had any bleeding episode during the trial at each of their testing intervals
was there any bleeding occurance during the accessed interval
Outcome measures
| Measure |
Group A: Subject on Lovaza Only
n=10 Participants
Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group B: Subject on Lovaza + Aspirin
n=12 Participants
Group B: Subject on study drug (Lovaza) plus Aspirin (\< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group C: Subject on Lovaza + Clopidogrel + Aspirin
n=10 Participants
Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (\< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
|
Group D: Subject on Lovaza + Warfarin + Aspirin
n=11 Participants
Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (\< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
|
|---|---|---|---|---|
|
The Occurence of Any Type of Bleeding
|
0 Number of occurance
|
1 Number of occurance
|
0 Number of occurance
|
0 Number of occurance
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=10 participants at risk
Lovaza only
|
Group B
n=12 participants at risk
Lovaza plus aspirin
|
Group C
n=10 participants at risk
Lovaza plus clopidogrel
|
Group D
n=11 participants at risk
Lovaza plus aspirin plus coumadin
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
16.7%
2/12 • Number of events 2 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/11 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
|
Gastrointestinal disorders
GI problem
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/12 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
18.2%
2/11 • Number of events 2 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
|
Blood and lymphatic system disorders
Minor Bleeding
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
8.3%
1/12 • Number of events 1 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/11 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
|
Gastrointestinal disorders
Elevated liver enzymes
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
8.3%
1/12 • Number of events 1 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/11 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
|
Cardiac disorders
Unknown medical issue
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/12 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
0.00%
0/10 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
9.1%
1/11 • Number of events 1 • Each patient was monitored for the full time period of 24 weeks, unless withdrawn from study early.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place