An Observational Study of TNKase in Patients Enrolled in the National Registry of Myocardial Infarction 4 and 5 (POST)

February 13, 2017 updated by: Genentech, Inc.

A Phase IV, Prospective, Observational Study of TNKase in Patients Enrolled in the National Registry of Myocardial Infarction 4 and 5 (POST)

The POST study comprised patients whose data were entered into the NRMI 4 and 5 databases. NRMI is a prospective, observational study of patients presenting with AMI in the United States. NRMI was launched in 1990 and to date has enrolled more than 2.5 million AMI patients. More than 1,700 hospitals have participated in NRMI during the last 16 years. The NRMI 4 and 5 substudies were sponsored by Genentech and collected data on approximately 160,000 AMI patients (both ST elevation and non-ST-elevation MI) hospitalized in the United States each year. This corresponds to approximately 18% of the AMI patients in the United States.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

253668

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of LBBB or ST-segment elevation (new or of unknown duration)
  • ICD-9-CM discharge code of 410.X1
  • Treatment with one of the following regimens: TNKase; Other thrombolytic regimens; No initial reperfusion

Exclusion Criteria:

  • Patients who were transferred out of the facility
  • Patients with pending data clarification forms on fields related to study variables

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2000

Primary Completion (Actual)

March 31, 2006

Study Completion (Actual)

March 31, 2006

Study Registration Dates

First Submitted

April 27, 2008

First Submitted That Met QC Criteria

April 27, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N2224n

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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