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

NCT ID: NCT00138034

Last Updated: 2012-04-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutaneous coronary intervention (PCI)

Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months

Group Type ACTIVE_COMPARATOR

Percutaneous coronary intervention (PCI)

Intervention Type PROCEDURE

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

Dual antiplatelet therapy

Aspirin and clopidogrel for at least 6 months

Group Type OTHER

Percutaneous coronary intervention (PCI)

Intervention Type PROCEDURE

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

Interventions

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Percutaneous coronary intervention (PCI)

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

Intervention Type PROCEDURE

Other Intervention Names

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bare metal stent placement

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Netherlands Heart Foundation

OTHER

Sponsor Role collaborator

The Interuniversity Cardiology Institute of the Netherlands

OTHER_GOV

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Heartcenter, University Medical Center St. Radboud

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. F.W.A. Verheugt

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Freek WA Verheugt, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Center

Locations

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Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2003B257

Identifier Type: OTHER

Identifier Source: secondary_id

APRICOT-3

Identifier Type: -

Identifier Source: org_study_id

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