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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138034
• Other study ID #: APRICOT-3
• Secondary ID: 2003B257
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: April 25, 2012
• Start date: January 2005
• Est. completion date: February 2010

Study information

• Verified date: April 2012
• Source: Heartcenter, University Medical Center St. Radboud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Percutaneous coronary intervention (PCI)
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland

Sponsors (5)

Lead Sponsor	Collaborator
Heartcenter, University Medical Center St. Radboud	Netherlands Heart Foundation, Pfizer, Sanofi, The Interuniversity Cardiology Institute of the Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography	The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.	6 months	Yes