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

NCT01997294 | Unknown DMC

• 2 other identifiers: RJH201301152011BAI11B05
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Keywords

sequential therapy; atorvastatin; acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Major Adverse Events (MACE) Occourance Rate

  1. 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)

  30 days

Secondary Outcomes (1)

• Secondary Endpoints

  12 months

Other Outcomes (1)

• Safty Endpoints

  12 months

Study Arms (2)

sequential therapy group

ACTIVE COMPARATOR

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

Usual Therapy of atorvastatin

PLACEBO COMPARATOR

20mg/d before and after PPCI for 1 year

Drug: Sequential therapy of atorvastatin

Interventions

Sequential therapy of atorvastatin DRUG

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

Usual Therapy of atorvastatin; sequential therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhang Qi, MD: lead

Study Sites (1)

Ruijin Hospital, Dept. of Cardiology

Shanghai, Shanghai Municipality, 200025, China

Location

Study Officials

• Weifeng Shen, MD. PhD.

  Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Visa Chief of Department of Cardiology

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 28, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 11, 2016

Record last verified: 2016-10

Locations

CN (1)