CClinicalTrials.gg
CompletedNCT01791764Updated Feb 15, 2013

Hospital Mortality in Patients Submitted to Pharmacoinvasive Strategy With Tenecteplase (TNK)

An observational study in Acute Coronary Syndrome, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Federal University of São Paulo · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
368
Ages
18 Years and older
Sex
All
01

Study summary

This study has the following objective:

To identify related factors to hospital mortality in patients with ST-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy within a structured healthcare network.

Read the detailed description

Primary percutaneous coronary intervention is the main therapy for patients with ST-segment elevation acute myocardial infarction. However, a significant portion of these patients won't receive optimal treatment due to the small number of tertiary centers with interventional laboratories available for 24 hours a day, 7 days a week.

Specially in large urban centers and rural areas, where tertiary care hospitals are restricted to a specific region, alternative approaches must be developed. The pharmacoinvasive strategy has emerged as an alternative for patients admitted to primary care centers. It is based in up-front intravenous thrombolytic therapy and transfer to a tertiary center where early, systematic, coronary intervention will be performed between 3 to 24 hours after the administration of thrombolytic drugs, even in cases in which successful reperfusion was obtained.

02

Conditions studied

  • Acute Coronary Syndrome
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 368 is below the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients will be selected from primary care clinic.

Inclusion criteria

  • Clinical diagnosis of ST-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy with tenecteplase.

Exclusion criteria

Exclusion Criteria:

  • Absence of obstructive coronary disease
  • Surgical reference
  • Did not undergo catheterization
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
368 participants (actual)
Target follow-up
15 Days
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Hospital Mortality

    Time frame: During hospital stay,an expected average of 15 days

07

Study locations

1 site
  • Federal University of Sao Paulo
    Sao Paulo, SP, Brazil
08

References and documents

Publications

  • Falcao FJ, Alves CM, Barbosa AH, Caixeta A, Sousa JM, Souza JA, Amaral A, Wilke LC, Perez FC, Goncalves Junior I, Stefanini E, Carvalho AC. Predictors of in-hospital mortality in patients with ST-segment elevation myocardial infarction undergoing pharmacoinvasive treatment. Clinics (Sao Paulo). 2013 Dec;68(12):1516-20. doi: 10.6061/clinics/2013(12)07. PubMed 24473509 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01791764
Lead sponsor
Federal University of São Paulo
Responsible party
Felipe José de Andrade Falcão (Master, Federal University of São Paulo) — Principal investigator
First posted
Feb 15, 2013
Start date
Nov 2010
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Feb 15, 2013

Study contacts

Felipe JA Falcao
principal investigator · Federal University of São Paulo
Claudia MR Alves, Doctor
principal investigator · Federal University of São Paulo
Antonio CC Carvalho
study director · Federal University of São Paulo
Adriano HP Barbosa
study director · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion