Multicenter Registry of early and Late Clinical Outcomes to Everolimus-eluting Cobalt-chromium Stent In patients with ST-elevation Acute Myocardial Infarctio

Not Applicable

• Conditions: ST-elevation Acute Myocardial Infarction

• Registration Number: JPRN-UMIN000021053
• Lead Sponsor: onprofit Organization Nakanihon PCI society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients participating in the other ongoing registry or clinical study(except post-marketing surveillance of CoCr-EES), or receiving treatment which may impact on endpoints of this study. 2)Patients presenting with cardiogenic shock 3)Patients for whom 9-month, 12-month and 36-month CAG and clinical follow up is considered difficult (patient's residence should also be taken into account) 4)Patients with responsible lesion in left main trunk 5)Patients with renal insufficiency or with chronic renal failure with serum creatinine level of 2.0mg/dL or higher at visit 6)Patients on hemodialysis 7)Patients with a known history of adverse drug reactions to aspirin, or clopidogrel or prasugrel (This may not apply if safety of ticlopidine is confirmed as an alternative drug.) 8)Patients who are below the age of 20 9)Women who were positive in pregnancy test or wish to become pregnant during study duration 10)Patients who newly developed AMI attributable to the prior stented site 11)Patients with a known history of allergy to drug, polymer, metal, and other materials used in CoCr-EES 12)Patients diagnosed with hepatic insufficiency 13)Patients with target lesion in saphenous vein graft 14)Patients with active malignant tumor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target vessel failure (TVF) at 12 months after CoCr-EES implantation. TVF consists of defined as cardiac death, target vessel-related recurrent myocardial infarction (MI) and TLR associated with the target vessel.

Secondary Outcome Measures

Name	Time	Method
MI (QMI and Non-QMI) at 9 months and 36months Any TLR at 9 months and 36months Any TVR at 9 months and 36months Death (All-cause death and Cardiac Death) at 9 months and 36months MACE (Cardiac death, MI and TLR) at 9 months and 36months Definite or Probable stent thrombosis defined by Academic research consortium (ARC)