Postpartum Low-Dose Aspirin After Preeclampsia for Optimization of Cardiovascular Risk (PAPVASC)
Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
Women who develop preeclampsia (PE) in pregnancy are at a greater risk for adverse
cardiovascular health outcomes. PE is associated with vascular remodeling and functional
changes in the postpartum, reflective of its systemic effects during gestation. Aberrant
microvascular endothelial function has been demonstrated in pharmacological studies of
formerly preeclamptic women. However, clinicians do not have any recourse for modulating
vascular functional adaptations nor mitigating the future risk for maternal disease in the
early postpartum. Low-dose aspirin (LD-ASA) is commonly prescribed to prevent PE and confers
a consistently positive effect on mitigating PE risk when given in early gestation to women
at risk. While the precise effect of LD-ASA on PE development is not fully understood,
existing evidence suggests it may confer an array of anti-thrombotic, vasodilatory,
pro-endothelial effects that mitigate the risk of disease.
This study will be a randomized, placebo-controlled trial of LD-ASA administration over 6
months in the early postpartum in women with prior severe PE. Women will be identified,
enrolled, and randomized to either treatment or placebo groups. Treatment groups will receive
81 mg daily oral aspirin, while control groups will receive an equivalent placebo pill.
Vascular functional assessment at study outset will take place, combining laser speckle
contrast imaging and iontophoresis of dilute vasoactive drug solutions. Blood and urine will
be obtained for analysis of cardiometabolic and endothelial factors. Participants will take
their assigned study drug for 6 months, after which a retest appointment will take place to
assess vascular functional changes.