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

Acute Coronary Syndrome Clinical Trial

— EvoACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418166
• Other study ID #: Yongtai Gong
• Status: Recruiting
• Start date: December 23, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: yongtai Gong, PhD
• Phone: 15945181294
• Email: gongth[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Evolocumab
evolocumab 140mg subcutaneous injection after regular take Ticagrelor and Aspirin for 5 days.

Locations

Country	Name	City	State
China	the first affiliated hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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