This trial is active, not recruiting.

Condition acute myocardial infarction
Treatment sequential therapy of atorvastatin
Sponsor Zhang Qi, MD
Start date January 2013
End date February 2017
Trial size 1200 participants
Trial identifier NCT01997294, 2011BAI11B05, RJH20130115


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year
sequential therapy of atorvastatin
80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI
(Placebo Comparator)
20mg/d before and after PPCI for 1 year
sequential therapy of atorvastatin
80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI

Primary Outcomes

Major Adverse Events (MACE) Occourance Rate
time frame: 30 days

Secondary Outcomes

Secondary Endpoints
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Sequential Therapy of Atorvastatin Improving Tissue Reperfusion and Clinical Outcomes of ST-elevated Acute Myocardial Infarction Study(The STRAIT Study)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine.