MedTrace Logo

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

NCT00138034 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-04-30

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

PROCEDURE

Percutaneous coronary intervention (PCI)

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

Sponsors & Collaborators

  • Netherlands Heart Foundation

    collaborator OTHER

  • The Interuniversity Cardiology Institute of the Netherlands

    collaborator OTHER_GOV

  • Pfizer

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • Heartcenter, University Medical Center St. Radboud

    lead OTHER

Principal Investigators

  • Freek WA Verheugt, MD PhD · Radboud University Nijmegen Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2010-01-31
Completion
2010-02-28

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
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 NCT00138034 on ClinicalTrials.gov