Clinical trial NCT00138034: APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: Open infarct-related artery within 72 hours of thrombolysis
Lead sponsor: Heartcenter, University Medical Center St. Radboud
Sponsor class: OTHER
Collaborators: name: Netherlands Heart Foundation
name: The Interuniversity Cardiology Institute of the Netherlands
name: Pfizer
name: Sanofi
First posted: 2005-08-30
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: 6-month Reocclusion
timeFrame: 6 months
Secondary outcomes:
measure: Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Freek WA Verheugt, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: