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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Sequential therapy of atorvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sequential therapy group<br>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<br>* 80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI<br>|
| Placebo Comparator: Usual Therapy of atorvastatin<br>20mg/d before and after PPCI for 1 year | Drug: Sequential therapy of atorvastatin<br>* 80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sequential therapy, atorvastatin, acute myocardial infarction