A Multicenter Randomized Trial in the Prevention of Reocclusion Following Successful Thrombolysis for Suspected Acute Myocardial Infarction: An Invasive Versus a Conservative Strategy
Sponsor study identifier
Secondary identifiers
OTHER · Netherlands Heart Foundation
interventional
49
1 country
1
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
February 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 29, 2005
Actual (reported)August 30, 2005
Actual (reported)January 2010
Actual (reported)February 2010
Actual (reported)April 19, 2012
Actual (reported)6-month Reocclusion
Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography
6 months
Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography
6 months
Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months
Aspirin and clopidogrel for at least 6 months
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500 HB, Netherlands
Freek WA Verheugt, MD PhD
Radboud University Nijmegen Medical Center
49 participants (actual enrollment reported by the registry).
First Submitted
August 29, 2005
First Posted
August 30, 2005
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2010
Actual (reported)Study Completion
February 2010
Actual (reported)Last Updated
April 30, 2012
Results First Posted
April 19, 2012
Record last verified: 2012-04
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