NCT03851263

Multislice Computed Tomography Assessment of PCSK9 Inhibition on Coronary Perfusion

Multi-slice CT Scan Assessment of the Impact of PCSK9 Inhibition With Evolocumab on Coronary Perfusion in Patients With Reduced Coronary Fractional Flow Reserve (FFR).

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ECRI bv · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The MARKOV study is an investigator-initiated, open-label, single arm, international, multicenter, 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. The study will be conducted in 5 sites in 3 different countries in Europe. Patients will receive evolocumab for approximately 3 year. The expected duration of the entire study from First Subject First Visit to Last Subject Last Follow-up is 46 months (3 year and 10 months).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab	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).

Timeline

• Start date: 2019-08-30
• Primary completion: 2021-08-27
• Completion: 2023-02-24
• First posted: 2019-02-22
• Last updated: 2019-12-06