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Completed

NCT Number: NCT00138034

APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3

Reocclusion of the infarct artery is observed in about 30% of patients within three months after successful thrombolysis for acute myocardial infarction (MI). Reocclusion is associated with an increased risk of death, reinfarction and the need for revascularization. Even in the absence of clinical reinfarction, reocclusion results in impaired left ventricular (LV) recovery, leaving patients at increased risk of developing heart failure in the long-term. Prevention of reocclusion is therefore warranted. In previous trials, severity of the infarct related stenosis was the only independent predictor of reocclusion. With a lack of clinical predictors of reocclusion, many cardiologists therefore empirically favor routine revascularization after successful thrombolysis.

The APRICOT-3 will be the first randomized trial in the current era of improved angioplasty techniques to study the question of whether a routine invasive strategy after successful thrombolysis can reduce the incidence of reocclusion and subsequently improve clinical outcome and LV-function. After successful thrombolysis, patients will be randomized to either a routine invasive strategy or an ischemia-guided strategy. The investigators expect to demonstrate a lower reocclusion rate at the 6-month follow-up angiography (primary endpoint) and fewer associated events (death, reinfarction, revascularization, admissions for heart failure) in the routine invasive arm. In search of non-invasive parameters predictive of reocclusion, laboratory analysis of several coagulation and inflammatory markers will be performed. Finally, pooled analysis of all 3 APRICOT trials will focus on the identification of clinical predictors of reocclusion that can easily be obtained by history and physical examination.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

About this study

Randomized controlled study of elective percutaneous coronary intervention (PCI) of an open culprit lesion after fibrinolysis for ST-elevation myocardial infarction (STEMI)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • TIMI-3 in infarct-related artery with a stentable lesion with 72 hours of thrombolysis for ST-elevation myocardial infarction

Exclusion criteria

  • Use of oral anticoagulants.
  • Known intolerance to aspirin or clopidogrel.
  • Bypass graft as infarct-related artery.
  • Previously dilated infarct related artery.
  • Significant left main stenosis.
  • Unidentifiable culprit stenosis.

Treatment and study plan

Percutaneous Coronary Intervention (PCI)

Procedure

PCI with bare metal stent placement of the culprit lesion the in the infarct related artery

Other names: bare metal stent placement

Primary outcomes

  1. 6-month Reocclusion

    Time frame: 6 months

    Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography

Secondary outcomes

  1. Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography

    Time frame: 6 months

    The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.

Sponsors and collaborators

Lead sponsor

Heartcenter, University Medical Center St. Radboud

Other

Collaborators

  • Netherlands Heart Foundation
  • Pfizer
  • Sanofi
  • The Interuniversity Cardiology Institute of the Netherlands

Registry information

Official study title

A Multicenter Randomized Trial in the Prevention of Reocclusion Following Successful Thrombolysis for Suspected Acute Myocardial Infarction: An Invasive Versus a Conservative Strategy

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Aug 30, 2005
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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