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document
ApoA-I induction as a potential cardioprotective strategy : rationale for the SUSTAIN and ASSURE studies . BACKGROUND Considerable interest has focused on the development of therapies that target the functionality of high-density lipoproteins ( HDL ) . Upregulation of endogenous synthesis of the major protein on HDL particles , apolipoprotein A-I ( apoA-I ) , represents a novel approach to generation of new HDL particles . The Study of Quantitative Serial Trends in Lipids with Apolipoprotein A-I Stimulation ( SUSTAIN , NCT01423188 ) study aims to evaluate the lipid efficacy , safety and tolerability of an apoA-I inducer ( RVX-208 ) . The ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation ( ASSURE , NCT01067820 ) study aims to evaluate the effect of RVX-208 on plaque burden . METHODS In SUSTAIN , 172 patients with low levels of HDL-C will be randomized to receive RVX-208 100 mg bid or placebo for 24 weeks . The primary efficacy parameter will be the percentage change in HDL-C levels . In ASSURE , 310 patients with angiographic coronary artery disease and low HDL-C levels will be randomized to receive RVX-208 100 mg bid or placebo for 26 weeks . The primary efficacy parameter will be the nominal change in percent atheroma volume ( PAV ) , determined by analysis of intravascular ultrasound ( IVUS ) images of matched coronary artery segments acquired at baseline and at 26-week follow-up . The effect of RVX-208 on other lipid and inflammatory markers , safety and tolerability will also be assessed in both studies . CONCLUSION ApoA-I induction represents a potential novel strategy to reduce cardiovascular risk , by generating nascent HDL particles . These studies will provide early evaluation of the effects of RVX-208 on lipids and atherosclerotic plaque .
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Intervention_Pharmacological
ApoA-I
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Intervention_Pharmacological
apolipoprotein A-I
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Intervention_Pharmacological
Apolipoprotein A-I Stimulation
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Intervention_Pharmacological
apoA-I inducer ( RVX-208 )
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Intervention_Pharmacological
RVX-208
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Intervention_Control
placebo
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Intervention_Pharmacological
RVX-208
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Intervention_Control
placebo
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Intervention_Pharmacological
RVX-208
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Outcome_Other
lipid efficacy
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Outcome_Other
safety
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Outcome_Other
tolerability
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Outcome_Physical
percentage change in HDL-C levels
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Outcome_Physical
percent atheroma volume ( PAV )
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Outcome_Physical
lipid and inflammatory markers
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Outcome_Other
safety
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Outcome_Other
tolerability
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Outcome_Physical
cardiovascular risk
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Participant_Condition
In SUSTAIN ,
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Participant_Condition
patients with low levels of HDL-C will be randomized
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Participant_Sample-size
310
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Participant_Condition
angiographic coronary artery disease