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

Myocardial Infarction Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

• NCT number: NCT00138034
• Study type: Interventional
• Source: Heartcenter, University Medical Center St. Radboud
• Status: Completed
• Phase: Phase 4
• Start date: January 2005
• Completion date: February 2010