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

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sequential therapy of atorvastatin
Sponsored by
Zhang Qi, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring sequential therapy, atorvastatin, acute myocardial infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ruijin Hospital, Dept. of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

sequential therapy group

Usual Therapy of atorvastatin

Arm Description

80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year

20mg/d before and after PPCI for 1 year

Outcomes

Primary Outcome Measures

Major Adverse Events (MACE) Occourance Rate
Cardiac Death (CD) 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) revascularization driven by syptoms (CABG or re-PCI)

Secondary Outcome Measures

Secondary Endpoints
TMP and TIMI grade chage after stents implantation; EKG ST reduction MACE ( same definition as primary endpoints)

Full Information

First Posted
November 22, 2013
Last Updated
October 9, 2016
Sponsor
Zhang Qi, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01997294
Brief Title
Sequential Therapy of Atorvastatin Improve Outcomes of ST-elevated Acute Myocardial Infarction
Official Title
Sequential Therapy of Atorvastatin Improving Tissue Reperfusion and Clinical Outcomes of ST-elevated Acute Myocardial Infarction Study（The STRAIT Study）
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhang Qi, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
sequential therapy, atorvastatin, acute myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sequential therapy group
Arm Type
Active Comparator
Arm Description
80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year
Arm Title
Usual Therapy of atorvastatin
Arm Type
Placebo Comparator
Arm Description
20mg/d before and after PPCI for 1 year
Intervention Type
Drug
Intervention Name(s)
Sequential therapy of atorvastatin
Intervention Description
80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI
Primary Outcome Measure Information:
Title
Major Adverse Events (MACE) Occourance Rate
Description
Cardiac Death (CD) 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) revascularization driven by syptoms (CABG or re-PCI)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Secondary Endpoints
Description
TMP and TIMI grade chage after stents implantation; EKG ST reduction MACE ( same definition as primary endpoints)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Safty Endpoints
Description
Impairment of liver and kidney function Other adverse events related to statin use
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weifeng Shen, MD. PhD.
Organizational Affiliation
Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University
Official's Role
Study Director
Facility Information:
Facility Name
Ruijin Hospital, Dept. of Cardiology
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Links:
URL
http://cdc.rocksh.cn/
Description
website provided by CRO

Learn more about this trial

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

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