Intensive Lipid Monitoring Following Percutaneous Coronary Intervention
AMGEN - Lipid Monitoring following Percutaneous Coronary Intervention (PCI)
Sponsor: Amgen Inc.
Enrolling: Male and Female Patients
Clinic Visits: 4
IRB Number: AAAT3045
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: This is a prospective, single-center, single-blind, two-arm, 1:1 randomized clinical trial. Patients who have undergone successful elective PCI will be screened with a lipid profile and eligible patients will be enrolled. Non-eligible patients will be enrolled in a registry. Randomization will be stratified by baseline LDL-C level and current statin therapy. In the intervention arm, LLT will be adjusted prior to discharge based on baseline LDL-C levels and according to a trial-specific algorithm for LLT; subjects and referring physicians will receive an algorithm with suggested LLT goals and therapeutic guidance according to repeat LDL-C levels. Subjects randomized to the control arm will receive standard post-elective PCI care (with follow-up calls as per study protocol). Telehealth monitoring and lipid profile assessment will occur at 2, 4, 6 and 12 months. All subjects will be followed via telephone. Subjects randomized to the intervention arm will receive specific instructions regarding LLT according to repeat LDL-C levels . A note will be sent to the referring physician with recommendations regarding LDL-C and non-HDL-C goals and LLT recommendations.
This study is closed
Investigator
Ajay Kirtane, MD, SM
Do You Qualify?
Are you willing to have bloodwork potentially 2 months, 4 months, 6 months, and 12 months after your PCI? Yes No
Are you already taking a PCSK9 inhibitor (ex: Evolocumab aka Repatha, Praluent aka alirocumab, Leqvio aka inclisiran)? Yes No
Do you have clinically significant liver disease? Yes No
Have you received an organ transplant or are you on a waiting list for an organ transplant? Yes No
Do you have active cancer? Yes No
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366