Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Progenitor Cells and Coronary Atherosclerosis in Humans

Phase 3 Completed 70 enrolled Mayo Clinic GlaxoSmithKline · collab National Heart, Lung, and Blood Institute (NHLBI) · collab National Institute on Aging (NIA) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

AIM III is a prospective, randomized, double-blinded, placebo controlled trial. The study is directly connected to IRB 08-008161 as a specific aim of the National Institute of Health (NIH) grant. Participants may either consent to and qualify for AIM I and AIM II (IRB 08-008161) or have a cardiac catheterization with acetylcholine testing in the Cardiac Catheterization Laboratory at Mayo Clinic in Rochester, Minnesota to be considered for this study.

Timeline

Start: 2010-02-04
Primary completion: 2015-11
Completion: 2015-11

Outcome

Missed primary endpoint

paper On follow-up, there was no significant difference in the percent response to acetylcholine of coronary artery diameter in treatment vs. placebo group (+3 (IQR -9, 15) vs. +3 (-12, 19); p=0.87) PMID 29306475 ↗

paper or coronary blood flow (-5 (IQR -24, 54) vs. 39 (IQR -26, 67); p=0.41). PMID 29306475 ↗

paper Lp-PLA2 inhibition with darapladib did not improve coronary endothelial function, despite significantly reduced Lp-PLA2 activity with darapladib. PMID 29306475 ↗

Publications

Prasad M, Lennon R, Barsness GW, Prasad A, Gulati R, Lerman LO, Lerman A. Chronic inhibition of lipoprotein-associated phospholipase A2 does not improve coronary endothelial function: A prospective, randomized-controlled trial. Int J Cardiol. 2018 Feb 15;253:7-13. doi: 10.1016/j.ijcard.2017.09.171.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darapladib	Small molecule	160 mg	Oral

Indications

No indication recorded.