Impact of Evolocumab in Cardiac Transplant Patients With CAV
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|ClinicalTrials.gov Identifier: NCT03944577|
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplant||Drug: Evolocumab (Repatha)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Evolocumab (Repatha) in Cardiac Transplant Patients With Coronary Allograft Vasculopathy|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||March 1, 2022|
Experimental: Treatment Arm
Patients who will receive the study drug.
Drug: Evolocumab (Repatha)
Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks. All study participants will receive instruction on correct self-administration by research pharmacists. Study drug will be mailed to patients on a monthly basis for self-administration by patients. The evolocumab dose (140 mg every 2 weeks) will remain constant for the duration of the study. Side effects will be assessed on a quarterly basis. Serious adverse events considered related to treatment, death, and pregnancy will all result in immediate discontinuation of the study drug.
- To measure the effect of evolocumab on serum LDL as measured in mL/dL after 12 weeks of therapy in heart transplant patients. [ Time Frame: 12 weeks ]The primary objective of this study is to measure in the impact of PCSK9 inhibition via evolocumab on serum LDL in heart transplant patients with CAV after 12 weeks compared to baseline. Change in serum LDL will serve as the primary endpoint for comparison.
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): NCT03944577
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Douglas Stoller, MD, PhD 402-559-1350 email@example.com|