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ST-elevation Myocardial InfarctionPhase 3NCT01334671

The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCI

A Phase 3 study testing Atorvastatin in people with ST-elevation Myocardial Infarction and (STEMI), run by General Hospital of Chinese Armed Police Forces at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the clinical effect of intensive statin therapy before emergency PCI in patients with STEMI. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
ST-elevation Myocardial Infarction, (STEMI)
What is being tested?
Atorvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
Feb 2011to Mar 2013
Phase
Phase 3
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

Who may be able to join

  • 1.Clinical diagnosis of STEMI less than 12 hours 2.Eligible for emergency PCI

Who cannot join

  • 1.Contradiction to atorvastatin 2.Contradiction to aspirin, clopidogrel and contrast medium 3.Life expectancy less than 3 months 4.Tumor or inflammatory diseases

Trial locations and contacts

1 site in 1 country.

HuiLiang LIU, Doctor contact

86-10-57976531

lhl518@vip.sina.com

Yong Yang, Doctor contact

86-10-57976533

yangyongfmmu@yahoo.com.cn

China1 site, 1 recruiting

  • General Hospital of Chinese People's Armed Police Forces

    Beijing, 100039

    HuiIiang Liu, Doctor, 86-10-57976531, lhl518@vip.sina.com

    Yong Yang, Doctor, 86-10-57976533, 672862837@qq.com;yangyongfmmu@yahoo.com.cn

    Recruiting

Other trials in China

About this study

Official title: The Clinical Effect of Intensive Statin Therapy in STEMI(ST-elevated Myocardial Infarction) Patients Before Emergency PCI(Percutaneous Coronary Intervention)

The purpose of this study is to evaluate the clinical effect of intensive statin therapy before emergency PCI in patients with STEMI.

Read the detailed description

150 STEMI patients planned for emergency PCI were randomized to three groups, Group 1:received atorvastatin 80-mg loading dose before PCI then followed by 40-mg daily for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 2:received atorvastatin 40-mg qd after PCI for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 3: received atorvastatin 20-mg qd after PCI (n=50).Before PCI,all subjects received oral administration of aspirin 300mg and clopidogrel 300mg.Levels of creatine kinase,CK-MB(creatine kinase-MB),were measured to estimate myocardial damage degree.HS-CRP(high sensitivity C -reactive protein),NO(NO synthase),SAA(Serum amyloid A) were measured at preoperation 1 hour,postoperative 24 and 72 hours,7days after PCI. To compare echocardiography changes among three groups.Patients enrolled in the study need to receive follow-up survey which was carried out by clinical doctors.Hence,MACEs were analyzed during 6-month follow-up.So, the aim of our study is to evaluate the clinical significance of loading dosage of atorvastatin therapy and analyze the mechanism underlying it.

Being tested
Atorvastatin
Keywords
ST-elevation myocardial infarction(STEMI), emergency percutaneous coronary intervention(PCI), lipitor or Atorvastatin
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Also called lipitol

    Group 1:80mg before PCI and 40mg per day after PCI for one month then 20mg per day until the end of the trial Group 2:40mg per day after PCI for one month then 20mg per day until the end of the trial Group 3:20mg per day after PCI until the end of the trial

Study groups in NCT01334671
Study groupRoleWhat they receive
group 1, AtorvastatinExperimentalSTEMI patients will be randomly divided into three groups Group 1 which has been give 80mg atorvastatin before PCI will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial
Receives: Drug: Atorvastatin
group 2 , AtorvastatinExperimentalGroup 2 will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial
Receives: Drug: Atorvastatin
group 3 , AtorvastatinExperimentalGroup 3 will be administered with atorvastatin 20mg per day until the end of the trial
Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACEs (Major adverse cardiac events)

    MACEs were compared among three groups during follow-up in STEMI patients undergoing emergency PCI.

    Measured: follow-up for 6 months

Secondary outcomes (4)

  1. Echocardiographic changes

    to compare echocardiographic changes ( left ventricular ejection fraction(LVEF); Left Ventricular Internal Diameter diastolic(LVIDd);Left Ventricular Internal Diameter systolic (LVIDs),Left Ventricular Enddiastolic Volume(LVEDV);Left Ventricular Endsystolic Volume(LVESV)at postoperative 6 month among three groups

    Measured: postoperative 6 month

  2. HS-CRP,NO,SAA values

    to compare hs-crp,no,saa values at differnt treatment period among three groups

    Measured: preoperation 1 hour,postoperative 24 and 72 hours,postoperative 7 days

  3. CK,CK-MB

    to estimate myocardial damage degree among three groups

    Measured: preoperation 1hour,postoperation 4/8/12/16/20/24hours

  4. AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride)

    to monitor adverse drug reaction

    Measured: preoperation 1 hour,postoperation 24 and 72hours,postoperation 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionDec 2012 (estimated)
  4. Study completionMar 2013 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01334671
Sponsor's protocol ID
W2-2009041
Status last verified
Apr 2011
First submitted
30 Mar 2011
Last updated
13 Apr 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Walter DH, Dimmeler S, Zeiher AM. Effects of statins on endothelium and endothelial progenitor cell recruitment. Semin Vasc Med. 2004 Nov;4(4):385-93. doi: 10.1055/s-2004-869595.

    PubMed 15861319

  • Wilson AM, Ryan MC, Boyle AJ. The novel role of C-reactive protein in cardiovascular disease: risk marker or pathogen. Int J Cardiol. 2006 Jan 26;106(3):291-7. doi: 10.1016/j.ijcard.2005.01.068.

    PubMed 16337036

  • Katayama T，Nakashima H，Yonekura T，et al. Significance of acutephase inflammatory reactants as an indicator of prognosis after acute myocardial infarction：which is the most useful predictor？J Cardiol，2003

  • Topol EJ. Intensive statin therapy--a sea change in cardiovascular prevention. N Engl J Med. 2004 Apr 8;350(15):1562-4. doi: 10.1056/NEJMe048061. Epub 2004 Mar 8. No abstract available.

    PubMed 15007111

  • Albrecht C，KaePPel N，Gauglitz G.Twoimmunoassay formats for fully automated CRPdetection in human serum【J」Anal Bioanal Chem，2008， 391(5):1845一1852.

  • Wu TL, I Chen Tsai, Chang PY, Tsao KC, Sun CF, Wu LL, Wu JT. Establishment of an in-house ELISA and the reference range for serum amyloid A (SAA): complementarity between SAA and C-reactive protein as markers of inflammation. Clin Chim Acta. 2007 Feb;376(1-2):72-6. doi: 10.1016/j.cca.2006.07.012. Epub 2006 Jul 15.

    PubMed 16916504

  • Antoniades C, Tousoulis D, Vasiliadou C, Pitsavos C, Chrysochoou C, Panagiotakos D, Tentolouris C, Marinou K, Koumallos N, Stefanadis C. Genetic polymorphism on endothelial nitric oxide synthase affects endothelial activation and inflammatory response during the acute phase of myocardial infarction. J Am Coll Cardiol. 2005 Sep 20;46(6):1101-9. doi: 10.1016/j.jacc.2005.05.072.

    PubMed 16168297

  • Liu HL, Yang Y, Yang SL, Luo JP, Li H, Jing LM, Shen ZQ. Administration of a loading dose of atorvastatin before percutaneous coronary intervention prevents inflammation and reduces myocardial injury in STEMI patients: a randomized clinical study. Clin Ther. 2013 Mar;35(3):261-72. doi: 10.1016/j.clinthera.2013.01.009. Epub 2013 Feb 12.

    PubMed 23410871

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atorvastatin in people with ST-elevation Myocardial Infarction and (STEMI), run by General Hospital of Chinese Armed Police Forces 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 1 inclusion and 1 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 13 Apr 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 HuiLiang LIU, Doctor (86-10-57976531, lhl518@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACEs (Major adverse cardiac events) (time frame: follow-up for 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01334671, which also lists 8 linked publications.

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 13 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.

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