PCSK 9 Inhibition as Secondary Prevention in Renal Transplant Patients
- Sponsor
- Hamid Al-Essa Organ Transplant Center
- Study ID
- NCT04665830
- Phase
- PHASE3
- Status
- Completed
Conditions
- Kideny Transplant Recipients With High Cardiovascular Risk Score
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Evolocumab — DRUGtreated patients with evolocumab for high cholesterol
Study Details
From this randomized controlled study, we aim to: A.Do do cardiovascular risk stratification of renal transplant recipients who are followed up in Hamed Al-Essa organ transplant center of Kuwait. B. To compare the effectiveness of a PCSK9 inhibitor plus maximum tolerated statin therapy vs. maximum tolerated statin therapy alone in the reduction of major cardiovascular events among renal transplant recipients with cardiovascular disease. C. To compare the effectiveness of a PCSK9 inhibitor plus maximum tolerated statin therapy vs. maximum tolerated statin therapy alone in terms of LDL-C-lowering, muscle symptoms, and quality of life. D. To compare patient adherence to the different treatment protocols.
Key Dates
- Start date
- May 1, 2018
- Status verified
- Dec 2020
- Primary completion
- May 1, 2020
- Completion
- May 1, 2020
Study Design
- Enrollment
- 200 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: Group 1Evolocumab group, patients who are receiving this therapy for 12 months.
- Placebo Comparator: Group 2The Statin group includes patients who are maintained on statin therapy.
Primary Outcome Measure
Any major cardiovascular events [ Time Frame: 24 months ]