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

April 25, 2012 updated by: Prof. Dr. F.W.A. Verheugt, Heartcenter, University Medical Center St. Radboud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Center

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:

  • 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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Percutaneous coronary intervention (PCI)
Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months
Procedure: Percutaneous coronary intervention (PCI)
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Other Names:
  • bare metal stent placement
Other: Dual antiplatelet therapy
Aspirin and clopidogrel for at least 6 months
Procedure: Percutaneous coronary intervention (PCI)
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Other Names:
  • bare metal stent placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

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

Sponsor

Heartcenter, University Medical Center St. Radboud

Collaborators

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

Investigators

  • Principal Investigator: Freek WA Verheugt, MD PhD, Radboud University Nijmegen Medical Center

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

January 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APRICOT-3
  • 2003B257 (Other Identifier: Netherlands Heart Foundation)

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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