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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01997294
• Other study ID #: RJH20130115
• Secondary ID: 2011BAI11B05
• Status: Active, not recruiting
• Phase: N/A
• First received: November 22, 2013
• Last updated: October 9, 2016
• Start date: January 2013
• Est. completion date: February 2017

Study information

• Verified date: October 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Sequential therapy of atorvastatin
80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI

Locations

Country	Name	City	State
China	Ruijin Hospital, Dept. of Cardiology	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Qi, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safty Endpoints	Impairment of liver and kidney function; Other adverse events related to statin use	12 months	Yes
Primary	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	No
Secondary	Secondary Endpoints	TMP and TIMI grade chage after stents implantation; EKG ST reduction; MACE ( same definition as primary endpoints)	12 months	No

External Links

•   website provided by CRO