The CHORAL Flow Study

Sponsor
Imperial College London
Study ID
NCT04073134
Phase
PHASE4
Status
Terminated

Conditions

  • Atherosclerosis
  • Coronary Artery Disease
  • Hyperlipidemias

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
  • Placebo — DRUG
    Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Study Details

CHORAL Flow is a randomised, double blinded, placebo-controlled trial of the effects of evolocumab on coronary flow at 12 weeks.

Key Dates

Start date
Sep 11, 2019
Status verified
Aug 2024
Primary completion
Mar 27, 2022
Completion
May 27, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Evolocumab
    Participants will receive evolocumab 140 mg subcutaneous injections once every 2 weeks.
  • Placebo Comparator: Placebo
    Participants will receive placebo subcutaneous injections once every 2 weeks.

Primary Outcome Measure

Maximal coronary flow velocity changes from baseline to 12 weeks [ Time Frame: Measured at baseline and after 12 weeks of therapy ]

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