Evocation Trial

JRCT ID: jRCTs051180022

Registered date:10/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: stable coronary artery disease
• Date of first enrollment: 22/03/2019
• Target sample size: 100
• Study type: Interventional

Intervention(s)

[Interventional treatment]
Evolocumab 140mg Q2W in addition to standard of care treatment
[Standard of care treatment]
Statins with/without drugs for hyperlipidemia including Ezetimib other than PCSK9 inhibitors according to approved usage and dose

Outcome(s)

• Primary Outcome: Index of microvascular resistance after PCI

Secondary Outcome

(1) Troponin T Level (Post-PCI)
(2)Change in Troponin T Level from Pre-PCI to Post-PCI
(3)Change in hs-CRP Level from Pre-PCI to Post-PCI
(4)Change in IL-6 Level from Pre-PCI to Post-PCI
(5)Change in PTX3 Level from Pre-PCI to Post-PCI
(6)Change in LOX-1 Level from Pre-PCI to Post-PCI
(7) LDL-C Level (Baseline, Pre-PCI)
(8)HDL-C Level (Baseline, Pre-PCI)
(9)Lp(a) Level (Baseline, Pre-PCI)
(10)hs-CRP Level (Baseline, Pre-PCI)
(11)IL-6 Level (Baseline, Pre-PCI)
(12)PTX3 Level (Baseline, Pre-PCI)
(13)LOX-1 Level (Baseline, Pre-PCI)
(14)BNP Level (Baseline, Pre-PCI)
(15)Perioperative myocardial infarction (Post-PCI)
(16)Perioperative myocardial damage (Post-PCI)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

(1)Patients aged 20 to 85 years.
(2)Patients with stable coronary artery disease who are planned to undergo PCI.
(3)Patients with high LDL-C levels after at least 2-week treatment of high-dose statin
(4)Patients who are capable of providing written consent.

Exclude criteria

(1)Any prior use of PCSK9 inhibitor therapy.
(2)Patients with previous MI in the terriory of the target coronary artery.
(3)Patients with target vessels which are two, three, or LMT.
(4)Patients with recent MI in past 6 weeks
(5)Patients with heart failure of New York Heart Failure Association class III or IV
(6)Patients with last known left ventricular ejection fraction <30%.
(7)Patients with serious renal impairment with an eGFR <30 mL/min/1.73m2 at screening
(8)Patients with hepatic dysfunction with AST or ALT 3-fold of upper limit of normal (ULN) at screening
(9)Patients who are pregnant, possibly pregnant, or breast feeding.
(10)Patients who have been enrolled in other clinical studies at the same time with this study (excluding observational studies such as registry studies).
(11)Patients who are judged by the investigator or subinvestigators to be not suitable for participation in the study.

Related Information

• Primary Sponsor: Ishihara Masaharu
• Source(s) of Monetary Support: Amgen K.K.
• Secondary ID(s): Nil known