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Status unknownNCT05418166EvoACSUpdated Jun 14, 2022

Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome

An observational study in Acute Coronary Syndrome, sponsored by First Affiliated Hospital of Harbin Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by First Affiliated Hospital of Harbin Medical University · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The aim of the present study is to investigate the effects of evolocumab in addition to statin therapy on platelet reactivity in patients with acute coronary syndrome (ACS) while on Ticagrelor and Aspirin treatment.

Read the detailed description

Ticagrelor is a commercially available antiplatelet adenosine diphosphate (ADP) antagonists. They exert their antiplatelet effects by binding to P2Y12 receptors on the platelet surface. Ticagrelor is used in combination with aspirin to prevent and treat thrombosis in patients with acute coronary syndrome, particularly after stent implantation.

Aspirin has an established role in the treatment of ACS and secondary prevention of ischaemic heart disease. Aspirin inhibits cyclo-oxygenase (COX) enzymes by irreversible acetylation to block platelet aggregation.

Evolocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). The use of evolocumab significantly reduced the incidence of cardiovascular events compared to statins alone. Whether the reduction in cardiovascular events is due to LDL reduction or other mechanisms is currently unclear.

02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • Evolocumab
  • Antiplatelet
  • Acute Coronary Syndrome
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's planned enrollment of 30 is below the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

First Affiliated Hospital of Harbin Medical University is the lead sponsor of 73 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients from the first affiliated hospital of Harbin Medical University.

Inclusion criteria

  1. Patients were diagnosed as acute coronary disease
  2. On therapy with Ticagrelor(90mg bid) and Aspirin(100mg qd), for at least 5 days.
  3. Fasting LDL-cholesterol ≥70 mg/dL or a non-high-density lipoprotein cholesterol (HDL-C) of ≥100 mg/dL after ≥4 weeks of optimized stable lipid-lowering therapy with maximally tolerated dose of statin.
  4. Have not used Evolocumab in 30 days.

Exclusion criteria

Exclusion Criteria:

  1. On treatment with any oral anticoagulant.
  2. On treatment with any antiplatelet agent other than Aspirin and Ticagrelor in the past 5 days.
  3. Creatinine clearance \<30 mL/minute.
  4. Known severe hepatic impairment.
  5. History of a serious hypersensitivity reaction to evolocumab
  6. Hemodynamic instability
  7. Pregnant and breastfeeding women.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • pro-Evo

    Patients regularly take Ticagrelor and Aspirin for five days.Platelet activity was test before inject Evolocumab.

  • 24h-Evo

    Patients regularly take Ticagrelor and Aspirin for five days, then inject Evolocumab 140mg. Platelet activity was test 24h after inject.

    Drug: Evolocumab

  • 1w-Evo

    Patients regularly take Ticagrelor and Aspirin for five days, then inject Evolocumab 140mg. Platelet activity was test 1 week after inject.

    Drug: Evolocumab

Interventions

  • DrugEvolocumab

    evolocumab 140mg subcutaneous injection after regular take Ticagrelor and Aspirin for 5 days.

06

What researchers measure

Primary outcomes

  1. Platelet Reactivity Defined by VerifyNow PU in Patients diagnosed ACS

    The primary end point of our study is the comparison of P2Y12 reaction units (PU) measured by VerifyNow in patients before use evolocumab and 24hours after injected and 1week after injected. PU is well-established measures of platelet reactivity and aggregation in response to antiplatelet medications. The higher is the PU the lower is the effect of the antiplatelet medication. Validity is defined as PU\<208.

    Time frame: 1 week

  2. Platelet Reactivity Defined by VerifyNow AU in Patients diagnosed ACS

    The second end point of our study is the comparison of COX-1 reaction units(AU) measured by VerifyNow in patients before use evolocumab and 24hours after injected and 1week after injected. AU is well-established measures of platelet reactivity and aggregation in response to antiplatelet medications. The higher is the AU the lower is the effect of the antiplatelet medication. Validity is defined as AU\<550.

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
  • the first affiliated hospital of Harbin Medical University
    Harbin, Heilongjiang 150000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05418166
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Responsible party
Sponsor
First posted
Jun 14, 2022
Start date
Dec 23, 2021
Primary completion
Sep 1, 2022 (estimated)
Completion
Sep 1, 2022 (estimated)
Last update
Jun 14, 2022

Study contacts

yongtai Gong, PhD
Contact
gongth@126.com
15945181294 ext. 0451-85553629

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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