- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01936103
Effects of Intensive Statin Treatment on Left Ventricular Function
September 2, 2013 updated by: Han Yaling, MD, Shenyang Northern Hospital
Effects of Intensive Statin Therapy on Left Ventricular Function for Patients With the First Acute Anterior Myocardial Infarction After Directly to Percutaneous Coronary Intervention.
First acute anterior myocardial infarction in patients with primary PCI preoperative and postoperative 30 days intensive dose atorvastatin statin therapy compared with conventional -dose therapy , patients can improve left ventricular function , reduce major adverse cardiovascular events .
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Geng Wang, Dr
- Phone Number: +86-24-28897280
- Email: Wanggeng69@hotmail.com
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110016
- Recruiting
- Shenyang Northen Hospital
-
Contact:
- Wang Geng, Dr
- Phone Number: 13309886393
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥ 18 years of age
- the first time clinical diagnosis of acute anterior myocardial infarction , the time of onset ≤ 12 hours ,intends underwent emergency PCI
- informed consent
Exclusion Criteria:
- Taking , or the need for long-term use of statins is greater than the initial dose
- treated with PCI again within a mouth
- active liver disease or liver dysfunction
- the diagnosis of myopathy
- severe renal insufficiency ( serum creatinine > 178umol / L )
- Statin drug allergy or had a serious adverse reaction
- severe aortic stenosis or mitral stenosis , hypertrophic obstructive cardiomyopathy , pericardial disease
- pregnancy
- malignancy or any other end-stage diseases result in a life expectancy of < 6 months
- be participating in other clinical studies
- not suitable for inclusion of the other cases
- not treated with PCI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: standard group
patients in this group received standard statin treatment: Atorvastatin statins 20mg / night .
|
standard statin treatment:Atorvastatin statins 20mg / night .
Other Names:
|
EXPERIMENTAL: intensive group
patients in this group received intensive statin treatment: Admission atorvastatin statins the 80mg, after surgery,atorvastatin 40mg / night,and until 30 days after the operation , and thereafter 20mg / night .
|
intensive statin treatment: Admission atorvastatin statins the 80mg, after surgery,atorvastatin 40mg / night,and until 30 days after the operation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
left ventricular function
Time Frame: 30 days
|
ultrasonic observation of left ventricular end-diastolic diameter
|
30 days
|
left ventricular function
Time Frame: 30 days
|
ultrasonic observation of left ventricular end-systolic volume
|
30 days
|
left ventricular function
Time Frame: 30 days
|
ultrasonic observation of left ventricular fractional shortening RWSI
|
30 days
|
left ventricular function
Time Frame: 30 days
|
ultrasonic observation of the left ventricular ejection fraction
|
30 days
|
left ventricular function
Time Frame: 30 days
|
ultrasonic observation of E/A
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the left ventricular function
Time Frame: 6 months
|
6 months
|
the left ventricular function
Time Frame: 1 year
|
1 year
|
plasma brain natriuretic peptide
Time Frame: 30days
|
30days
|
plasma brain natriuretic peptide
Time Frame: 6 months
|
6 months
|
plasma brain natriuretic peptide
Time Frame: 1 year
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
enzymes
Time Frame: 1 year
|
the level of CK peak
|
1 year
|
Major adverse cardiac and cerebral events at 1 year
Time Frame: 1 year
|
1 year after death, cardiac death , myocardial infarction , heart failure , cardiac causes hospitalization , revascularization combined endpoint of cerebrovascular events .
|
1 year
|
Aspartate aminotransferase (AST)
Time Frame: 1 year
|
Aspartate aminotransferase (AST) returned to normal in the perioperative period
|
1 year
|
enzymes
Time Frame: 1 year
|
CK-MB peak
|
1 year
|
enzymes
Time Frame: 1 year
|
troponin (TnT)
|
1 year
|
enzymes
Time Frame: 1 year
|
CK-MB peak time
|
1 year
|
Aspartate aminotransferase (AST)
Time Frame: 1 year
|
any elevation> 3 times the proportion
|
1 year
|
alanine aminotransferase (ALT)
Time Frame: 1 year
|
alanine aminotransferase (ALT)returned to normal in the perioperative period
|
1 year
|
alanine aminotransferase (ALT)
Time Frame: 1 year
|
any elevation> 3 times the proportion
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Geng Wang, Dr, Shenyang Northern Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (ANTICIPATED)
May 1, 2014
Study Completion (ANTICIPATED)
July 1, 2014
Study Registration Dates
First Submitted
April 23, 2013
First Submitted That Met QC Criteria
September 2, 2013
First Posted (ESTIMATE)
September 5, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 2, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Anterior Wall Myocardial Infarction
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- NH-20120404
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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