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

Study Overview
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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)

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention (PCI)


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous coronary intervention (PCI)<br>Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months | Procedure: Percutaneous coronary intervention (PCI)<br>* PCI with bare metal stent placement of the culprit lesion the in the infarct related artery<br>* Other names: bare metal stent placement;|
| Other: Dual antiplatelet therapy<br>Aspirin and clopidogrel for at least 6 months | Procedure: Percutaneous coronary intervention (PCI)<br>* PCI with bare metal stent placement of the culprit lesion the in the infarct related artery<br>* Other names: bare metal stent placement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open infarct-related artery within 72 hours of thrombolysis