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

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Evolocumab

• Registration Number: NCT05418166
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

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.

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.

Study Timeline

• Study Start: 2021-12-23
• Status Verified: 2022-04
• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1w-Evo	Evolocumab	Patients regularly take Ticagrelor and Aspirin for five days, then inject Evolocumab 140mg. Platelet activity was test 1 week after inject.
24h-Evo	Evolocumab	Patients regularly take Ticagrelor and Aspirin for five days, then inject Evolocumab 140mg. Platelet activity was test 24h after inject.

Primary Outcome Measures

Name	Time	Method
Platelet Reactivity Defined by VerifyNow PU in Patients diagnosed ACS	1 week	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.
Platelet Reactivity Defined by VerifyNow AU in Patients diagnosed ACS	1 week	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.

Trial Locations

Locations (1)

the first affiliated hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China