Acute Anterior Myocardial InfarctionPhase 4NCT01936103
Effects of Intensive Statin Treatment on Left Ventricular Function
A Phase 4 study testing standard group and intensive group in people with Acute Anterior Myocardial Infarction, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Anterior Myocardial Infarction
- What is being tested?
- standard group and intensive group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Jul 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenyang Northen Hospital
Shenyang, Liaoning, 110016
Wang Geng, Dr, 13309886393
About this study
Official title: 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 .
- Conditions
- Acute Anterior Myocardial Infarction
- Being tested
- standard group, intensive group
- Keywords
- Acute anterior myocardial infarction, Percutaneous coronary stent implantation, Intensive statin therapy, Left ventricular function
- Medical subject headings
- Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard groupDrug
Also called Lipitor
standard statin treatment:Atorvastatin statins 20mg / night .
intensive groupDrug
Also called intensive Lipitor
intensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation
| Study group | Role | What they receive |
|---|---|---|
| standard group | Active comparator | patients in this group received standard statin treatment： Atorvastatin statins 20mg / night . Receives: Drug: standard group |
| intensive group | Experimental | 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 . Receives: Drug: intensive group |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular function
ultrasonic observation of left ventricular end-diastolic diameter
Measured: 30 days
left ventricular function
ultrasonic observation of left ventricular end-systolic volume
Measured: 30 days
left ventricular function
ultrasonic observation of left ventricular fractional shortening RWSI
Measured: 30 days
left ventricular function
ultrasonic observation of the left ventricular ejection fraction
Measured: 30 days
left ventricular function
ultrasonic observation of E/A
Measured: 30 days
Secondary outcomes (5)
the left ventricular function
Measured: 6 months
the left ventricular function
Measured: 1 year
plasma brain natriuretic peptide
Measured: 30days
plasma brain natriuretic peptide
Measured: 6 months
plasma brain natriuretic peptide
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startApr 2012
- Primary completionMay 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Anterior Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, MD, Shenyang Northern Hospital
- Investigators
- Geng Wang, Dr, Study director, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936103
- Sponsor's protocol ID
- NH-20120404
- Status last verified
- Aug 2013
- First submitted
- 23 Apr 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Statin Therapy on Left Ventricular Function for Patients With the First Acute Anterior Myocardial Infarction After Directly to Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT01936103
- Acronym / sponsor ID
- NH-20120404
- Conditions
- Acute Anterior Myocardial Infarction
- Keywords
- Acute anterior myocardial infarction, Percutaneous coronary stent implantation, Intensive statin therapy, Left ventricular function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 5 Sep 2013 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | Active comparator | Drug: standard grouppatients in this group received standard statin treatment： Atorvastatin statins 20mg / night . |
| intensive group | Experimental | Drug: intensive grouppatients 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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (12 listed)
- 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 )
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 |
|---|---|---|
| standard groupAlso: Lipitorstandard statin treatment:Atorvastatin statins 20mg / night . | Drug | standard group |
| intensive groupAlso: intensive Lipitorintensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation | Drug | intensive group |
Primary outcome
left ventricular function
Time frame: 30 days
ultrasonic observation of left ventricular end-diastolic diameter
left ventricular function
Time frame: 30 days
ultrasonic observation of left ventricular end-systolic volume
left ventricular function
Time frame: 30 days
ultrasonic observation of left ventricular fractional shortening RWSI
left ventricular function
Time frame: 30 days
ultrasonic observation of the left ventricular ejection fraction
left ventricular function
Time frame: 30 days
ultrasonic observation of E/A
5 secondary outcomes
the left ventricular function
Time frame: 6 months
the left ventricular function
Time frame: 1 year
plasma brain natriuretic peptide
Time frame: 30days
plasma brain natriuretic peptide
Time frame: 6 months
plasma brain natriuretic peptide
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
Geng Wang, Dr study director
Shenyang Northern Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing standard group and intensive group in people with Acute Anterior Myocardial Infarction, run by Shenyang Northern Hospital 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 3 inclusion and 12 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 5 Sep 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Geng Wang, Dr (+86-24-28897280, Wanggeng69@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular function (time frame: 30 days). The study lists 5 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 5 Sep 2013.