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Sequential Therapy of Atorvastatin Improve Outcomes of ST-elevated Acute Myocardial Infarction

Z

Zhang Qi, MD

Status

Unknown

Conditions

Acute Myocardial Infarction

Treatments

Drug: Sequential therapy of atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01997294
RJH20130115
2011BAI11B05 (Other Grant/Funding Number)

Details and patient eligibility

About

Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment.

Enrollment

1,200 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Sighed informed consent
  • Diagnosised as acute myocardial infarction
  • Time frame less than 12 hours since the occurance of chest pain
  • Aggred to receive sirolimus-eluted coronary stents
  • Patients willing to accepte follow-up

Exclusion criteria

  • Allegy to statins or with a history against statin therapy
  • Allegy to any products that will be used during PPCI
  • Disagreed to receive PPCI and other related therapy
  • Existing sever liver dysfuntion that statins can not be used according to the guildlines
  • Sever kidney dysfunction (creatinine >3mg/dl or eGFR<30ml/min)
  • Sever left ventricular dysfunction (Killip grade 3)
  • Patients are currently taking medicine that may influence the use of statin
  • Patients with a history of alcohol abuse or durg abuse
  • Woman during pregnancy or lactation
  • Patients who has attended other clinical trials
  • Patients who has received PCI or CABG previously
  • Patients who can not agree to accept study protocol
  • Other conditions that may not sutible for the current study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,200 participants in 2 patient groups, including a placebo group

sequential therapy group
Active Comparator group
Description:
80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year
Treatment:
Drug: Sequential therapy of atorvastatin
Usual Therapy of atorvastatin
Placebo Comparator group
Description:
20mg/d before and after PPCI for 1 year
Treatment:
Drug: Sequential therapy of atorvastatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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