Acute Coronary SyndromeEvoACSNCT05418166
Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the first affiliated hospital of Harbin Medical University.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
yongtai Gong, PhD, 15945181294, gongth@126.com
About this study
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Evolocumab
- Keywords
- Evolocumab, Antiplatelet, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
evolocumab 140mg subcutaneous injection after regular take Ticagrelor and Aspirin for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start23 Dec 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418166
- Sponsor's protocol ID
- Yongtai Gong
- Acronym
- EvoACS
- Status last verified
- Apr 2022
- First submitted
- 5 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05418166
- Acronym / sponsor ID
- EvoACS / Yongtai Gong
- Conditions
- Acute Coronary Syndrome
- Keywords
- Evolocumab, Antiplatelet, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pro-Evo | – | –Patients regularly take Ticagrelor and Aspirin for five days.Platelet activity was test before inject Evolocumab. |
| 24h-Evo | – | Drug: EvolocumabPatients regularly take Ticagrelor and Aspirin for five days, then inject Evolocumab 140mg. Platelet activity was test 24h after inject. |
| 1w-Evo | – | Drug: EvolocumabPatients regularly take Ticagrelor and Aspirin for five days, then inject Evolocumab 140mg. Platelet activity was test 1 week after inject. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the first affiliated hospital of Harbin Medical University.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evolocumabevolocumab 140mg subcutaneous injection after regular take Ticagrelor and Aspirin for 5 days. | Drug | 1w-Evo, 24h-Evo |
Primary outcome
Platelet Reactivity Defined by VerifyNow PU in Patients diagnosed ACS
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yongtai Gong, PhD (15945181294 ext. 0451-85553629, gongth@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Reactivity Defined by VerifyNow PU in Patients diagnosed ACS (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.