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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01997294
Enrollment
1200
Registered
2013-11-28
Start date
2013-01-31
Completion date
2017-02-28
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

sequential therapy, atorvastatin, acute myocardial infarction

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.

Interventions

DRUGSequential therapy of atorvastatin

80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI

Sponsors

Zhang Qi, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Events (MACE) Occourance Rate30 days1. 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)

Secondary

MeasureTime frameDescription
Secondary Endpoints12 months1. TMP and TIMI grade chage after stents implantation; EKG ST reduction 2. MACE ( same definition as primary endpoints)

Other

MeasureTime frameDescription
Safty Endpoints12 months1. Impairment of liver and kidney function 2. Other adverse events related to statin use

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026