NCT01936103

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 5, 2013

Status Verified

August 1, 2013

Enrollment Period

2.1 years

First QC Date

April 23, 2013

Last Update Submit

September 2, 2013

Conditions

Acute Anterior Myocardial Infarction

Keywords

Acute anterior myocardial infarctionPercutaneous coronary stent implantationIntensive statin therapyLeft ventricular function

Outcome Measures

Primary Outcomes (5)

  • left ventricular function

    ultrasonic observation of left ventricular end-diastolic diameter

    30 days

  • left ventricular function

    ultrasonic observation of left ventricular end-systolic volume

    30 days

  • left ventricular function

    ultrasonic observation of left ventricular fractional shortening RWSI

    30 days

  • left ventricular function

    ultrasonic observation of the left ventricular ejection fraction

    30 days

  • left ventricular function

    ultrasonic observation of E/A

    30 days

Secondary Outcomes (5)

  • the left ventricular function

    6 months

  • the left ventricular function

    1 year

  • plasma brain natriuretic peptide

    30days

  • plasma brain natriuretic peptide

    6 months

  • plasma brain natriuretic peptide

    1 year

Other Outcomes (9)

  • enzymes

    1 year

  • Major adverse cardiac and cerebral events at 1 year

    1 year

  • Aspartate aminotransferase (AST)

    1 year

  • +6 more other outcomes

Study Arms (2)

standard group

ACTIVE COMPARATOR

patients in this group received standard statin treatment： Atorvastatin statins 20mg / night .

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 .

Drug: intensive group

Interventions

standard groupDRUG

standard statin treatment:Atorvastatin statins 20mg / night .

Also known as: Lipitor
standard group
intensive groupDRUG

intensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation

Also known as: intensive Lipitor
intensive group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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 treated with PCI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenyang Northen Hospital

Shenyang, Liaoning, 110016, China

RECRUITING

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Geng Wang, Dr

    Shenyang Northern Hospital

    STUDY DIRECTOR

Central Study Contacts

Geng Wang, Dr

CONTACT

+86-24-28897280Wanggeng69@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president

Study Record Dates

First Submitted

April 23, 2013

First Posted

September 5, 2013

Study Start

April 1, 2012

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

September 5, 2013

Record last verified: 2013-08

Locations

CN(1)