Clinical trial NCT05418166: Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome
Official title: Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: Evolocumab
Antiplatelet
Acute Coronary Syndrome
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Platelet Reactivity Defined by VerifyNow PU in Patients diagnosed ACS
timeFrame: 1 week
measure: Platelet Reactivity Defined by VerifyNow AU in Patients diagnosed ACS
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: the first affiliated hospital of Harbin Medical University
state: Heilongjiang
Study officials:
References: