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

• Sponsor: First Affiliated Hospital of Harbin Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05418166
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 8.3
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: Evolocumab

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 Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome
• Actual Study Start Date: Dec 23, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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; 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.	Drug: Evolocumab; evolocumab 140mg subcutaneous injection after regular take Ticagrelor and Aspirin for 5 days.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the first affiliated hospital of Harbin Medical University	Harbin	Heilongjiang	China	150000

Sponsors and Collaborators

• First Affiliated Hospital of Harbin Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: First Affiliated Hospital of Harbin Medical University
• ClinicalTrials.gov Identifier: NCT05418166
• Other Study ID Numbers: Yongtai Gong
• First Posted: Jun 14, 2022
• Last Update Posted: Jun 14, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by First Affiliated Hospital of Harbin Medical University: Evolocumab; Antiplatelet; Acute Coronary Syndrome
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome; Evolocumab

Study Results

No Results Posted as of Jun 14, 2022