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NCT00669045 Clinical Trial

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

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00669045
Other study ID # N2224n
Secondary ID
Status Completed
Phase N/A
First received April 27, 2008
Last updated February 13, 2017
Start date September 1, 2000
Est. completion date March 31, 2006

Study information
Verified date February 2017
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 253668
Est. completion date March 31, 2006
Est. primary completion date March 31, 2006
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Genentech, Inc.
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