Multislice Computed Tomography Assessment of PCSK9 Inhibition on Coronary Perfusion

Sponsor
ECRI bv
Study ID
NCT03851263
Phase
PHASE4
Status
Withdrawn

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Subcutaneous injection, using a pre-filled auto-injector pen. Each pen contains 1.0 ml fluid (containing 140 mg evolocumab) which is injected in the abdomen, thigh or outer area of upper arm every 2 weeks (q2w).

Study Details

The MARKOV study is an investigator-sponsored single arm, prospective study to assess the effect of evolocumab on the improvement in coronary flow (FFRCT) after 18 and 36 months of treatment in patients with coronary atherosclerosis.

Key Dates

Start date
Aug 30, 2019
Status verified
Dec 2019
Primary completion
Aug 27, 2021
Completion
Feb 24, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab
    All subjects are treated with evolocumab 140mg every 2 weeks (q2w) starting on day 1 and ending on day 1071 (week 153).

Primary Outcome Measure

Mean change in normalized area under the curve of fractional flow reserve derived from coronary computed tomography(CCTA) (FFRCT) at 18 months from baseline [ Time Frame: 18 months of treatment ]

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