Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Progenitor Cells and Coronary Atherosclerosis in Humans
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|ClinicalTrials.gov Identifier: NCT01067339|
Recruitment Status : Completed
First Posted : February 11, 2010
Results First Posted : March 15, 2017
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Endothelial Dysfunction||Drug: darapladib Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Lp-PLA2, Progenitor Cells and Coronary Atherosclerosis in Humans AIM III|
|Study Start Date :||February 4, 2010|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
darapladib, tablet, 160 mg, by mouth, one time daily, 6 month duration
Placebo Comparator: Placebo
Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
placebo, by mouth, once daily for six months
- Percentage Change in Coronary Artery Diameter [ Time Frame: baseline, six months ]The change of coronary artery diameter was measured in response to a maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary artery diameter provides a measure of endothelium dependent epicardial function.
- Percentage Change in Coronary Blood Flow (CBF) [ Time Frame: baseline, six months ]The change in coronary blood flow was measured in response to maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary blood flow provides a measure of endothelium dependent microvascular function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067339
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amir Lerman, MD||Mayo Clinic|