Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI
NCT ID: NCT05613426
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
330 participants
INTERVENTIONAL
2023-04-03
2026-12-30
Brief Summary
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Eligible patients were randomly randomized 1:1:1 to one of the following three groups immediately after enrollment: (1) Intensive statin group: rosuvastatin 20 mg per day, in addition to usual therapy; (2) Combined intensive statin and PCSK9 inhibitor group: rosuvastatin 20 mg per day and subcutaneous injection of evolocumab 140 mg twice a month, for at least 3 months, and preferably 6 months; (3) PCSK9 inhibitor alone group: subcutaneous injection of evolocumab 140 mg, twice a month for at least 3 months and preferably 6 months.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intensive statin group
Rosuvastatin, 20 mg per day after randomization
Rosuvastatin 20 mg
Very early use of Rosuvastatin before primary PCI in anterior STEMI
Combined intensive statin and PCSK9 inhibitor group
Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization
Rosuvastatin 20 mg
Very early use of Rosuvastatin before primary PCI in anterior STEMI
Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]
Very early use of Evolocumab before primary PCI in anterior STEMI
PCSK9 inhibitor alone group
Evolocumab, 140 mg twice a month after randomization
Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]
Very early use of Evolocumab before primary PCI in anterior STEMI
Interventions
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Rosuvastatin 20 mg
Very early use of Rosuvastatin before primary PCI in anterior STEMI
Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]
Very early use of Evolocumab before primary PCI in anterior STEMI
Eligibility Criteria
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Inclusion Criteria
* Persistent chest pain or chest discomfort
* Onset within 12 hours
* ST-segment elevation ≥0.1 millivolt in two adjacent precordial leads, or a new-onset left bundle branch block with dynamic changes
* Primary PCI is planned
Exclusion Criteria
* Prior intravenous thrombolytic therapy
* Prior use of Statins, PCSK9 inhibitors or Ezetimibe
* Cardiogenic shock
* Acute heart failure or pulmonary edema
* Prior chronic heart failure
* Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \<30ml/min/1.73m2, or on dialysis)
* Prolonged (\> 20 minutes) cardiopulmonary resuscitation
* Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)
* Malignant arrhythmias that are difficult to control with drugs
* Severe chronic obstructive pulmonary disease or respiratory failure
* Severe infection
* Neurological disorders
* Bleeding history of cerebrovascular, gastrointestinal, respiratory, urinary or other organs within the last month
* Active bleeding or bleeding diatheses
* Use of anticoagulants
* Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year
* Pregnant or lactating women
18 Years
75 Years
ALL
No
Sponsors
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Henan Institute of Cardiovascular Epidemiology
OTHER
Responsible Party
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Chuanyu Gao
Vice President, Chief of Cardiology Department
Locations
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The People's Hospital of Gongyi
Gongyi, Henan, China
Kaifeng Central Hospital
Kaifeng, Henan, China
The People's Hospital of Changyuan
Xinxiang, Henan, China
Hopeshine Minsheng Hospital of Xinzheng
Xinzheng, Henan, China
The People's Hospital of Xuchang
Xuchang, Henan, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Lei Li
Role: primary
Jieyun Liu
Role: primary
Guangyan He
Role: primary
Yanhong Li
Role: primary
Shuya Zhou
Role: primary
Junhui Zhang, Doctor
Role: primary
Other Identifiers
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HenanICE202204
Identifier Type: -
Identifier Source: org_study_id