To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory effect of a low dose Immediate Release Aspirin (IR ASA) regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Naproxen sodium 220 mg qd or bid
ASA 81 mg qd
Unnamed facility
Austin, Texas, United States
Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration
Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.
Time frame: At hour 24 on Day 16 post treatment
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
Time frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.
Time frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
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Time frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19