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

NCT05418166 | Unknown DMC FDA Drug

• 1 other identifier: Yongtai Gong
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome

Keywords

Evolocumab; Antiplatelet; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  1 week

• 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.

  1 week

Study Arms (3)

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

Evolocumab DRUG

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

1w-Evo; 24h-Evo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the first affiliated hospital of Harbin Medical University.

You may qualify if:

• Patients were diagnosed as acute coronary disease
• On therapy with Ticagrelor(90mg bid) and Aspirin(100mg qd), for at least 5 days.
• 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.
• Have not used Evolocumab in 30 days.

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

the first affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

about 4ml plasma in -80℃ refrigerator

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

yongtai Gong, PhD

CONTACT

15945181294; gongth@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 14, 2022
• Study Start: December 23, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-04

Locations

CN (1)