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Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients

NCT00257309 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2017-01-19

Study results available
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Summary

General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of thrombolytic therapy (TT) for the treatment of AMI in patients \>=75 years old with ST-segment elevation or LBBB AMI \<6 hours of evolution without contraindications for TT.

Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT in patients \>=75 years old with AMI.

Participating Centers: 27 Spanish hospitals performing \>50 PA/year. Primary Endpoint (PE): Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30 days. There are also 7 secondary endpoints (SE).

Procedure: Diagnosis of inclusion/exclusion criteria --\> Centralized randomization --\> Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months. Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days and 12 months. Quality control: 100% variable and follow-up review by external CRO. Safety Committee and Event Adjudication Committee formed by experts not participating in the study.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

Tenecteplase + UFH (+ clopidogrel, since 01/97)

PROCEDURE

Primary angioplasty

Sponsors & Collaborators

  • Fondo de Investigacion Sanitaria

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • Cordis Corporation

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • Guidant Corporation

    collaborator INDUSTRY

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Spanish Society of Cardiology

    lead OTHER

Principal Investigators

  • Hector Bueno, MD, PhD · Spanish Society of Cardiology (WG on Ischemic Heart Disease and CCUs)

  • Rosa Ana Hernández-Antolín, MD · Spanish Society of Cardiology (WG on Interventional Cardiology)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-02-29
Completion
2008-12-31

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00257309 on ClinicalTrials.gov