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

NCT ID: NCT05418166

Last Updated: 2022-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-23

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pro-Evo

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

No interventions assigned to this group

24h-Evo

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

Evolocumab

Intervention Type DRUG

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

1w-Evo

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

Evolocumab

Intervention Type DRUG

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

Interventions

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Evolocumab

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

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the first affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yongtai Gong, PhD

Role: CONTACT

15945181294 ext. 0451-85553629

Facility Contacts

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yongtai Gong, PhD

Role: primary

15945181294

Other Identifiers

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Yongtai Gong

Identifier Type: -

Identifier Source: org_study_id

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