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

October 9, 2016 updated by: Zhang Qi, MD

Sequential Therapy of Atorvastatin Improving Tissue Reperfusion and Clinical Outcomes of ST-elevated Acute Myocardial Infarction Study（The STRAIT Study）

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital, Dept. of Cardiology

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Events (MACE) Occourance Rate
Time Frame: 30 days
  1. Cardiac Death (CD)
  2. Non-fatal re-inarction (CK-MB, cTNI or cTNT elevation again and over 3 times higher than up normal limit accompanied with syptoms or EKG indication)
  3. revascularization driven by syptoms (CABG or re-PCI)
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoints
Time Frame: 12 months
  1. TMP and TIMI grade chage after stents implantation; EKG ST reduction
  2. MACE ( same definition as primary endpoints)
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safty Endpoints
Time Frame: 12 months
  1. Impairment of liver and kidney function
  2. Other adverse events related to statin use
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhang Qi, MD

Investigators

  • Study Director: Weifeng Shen, MD. PhD., Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2013

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 9, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH20130115
  • 2011BAI11B05 (Other Grant/Funding Number: Ministry of Science and Techology of the Pelple's Republic of China)

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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