Status:
COMPLETED
PCSK 9 Inhibition as Secondary Prevention in Renal Transplant Patients
Lead Sponsor:
Hamid Al-Essa Organ Transplant Center
Conditions:
Kideny Transplant Recipients With High Cardiovascular Risk Score
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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....
Detailed Description
Background: Low-density lipoprotein (LDL) cholesterol is a well-established and modifiable risk factor for cardiovascular disease. Monoclonal antibodies that inhibit proprotein convertase subtilisin-...
Eligibility Criteria
Inclusion
- 1\. Signed informed consent, 2. Male or female Kuwaiti older than 30 and younger than ≤ 80 years of age at the signing of informed consent 3. History of clinically evident cardiovascular disease(diagnosis of myocardial infarction; non-hemorrhagic stroke or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with the ankle-brachial index (ABI) \< 0.85, or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease, 4. At least 1 major risk factor or at least 2 minor risk factors below: Major Risk Factors (1 Required): o diabetes (type 1 or type 2) o age ≥ 65 years at randomization (and ≤ 85 years at the time of informed consent) o MI or non-hemorrhagic stroke within 6 months of screening o additional diagnosis of myocardial infarction or non-hemorrhagic stroke excluding qualifying MI or non-hemorrhagic stroke o current daily cigarette smoking o history of symptomatic PAD (as mentioned before) if eligible by MI or stroke history; Minor Risk Factors (2 Required): o history of non-MI related coronary revascularization o residual coronary artery disease with ≥ 40% stenosis in ≥ 2 large vessels o Most recent HDL-C \<1.0 mmol/L for men and \<1.3 mmol/L for women by the central laboratory before randomization o Most recent CRP \> 2.0 mg/L by the central laboratory before randomization o Most recent LDL-C ≥ 3.4 mmol/L or non-HDL-C ≥ 4.1 mmol/L by the central laboratory before randomization o metabolic syndrome.
Exclusion
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04665830
Start Date
May 1 2018
End Date
May 1 2020
Last Update
December 14 2020
Active Locations (1)
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1
OTC, MOH , Kuwait
Kuwait City, Kuwait, Kuwait