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

Heartcenter, University Medical Center St. Radboud

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Procedure: Percutaneous coronary intervention (PCI)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00138034

APRICOT-3

2003B257 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 49 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Percutaneous coronary intervention (PCI)

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous coronary intervention (PCI)

Dual antiplatelet therapy

Other group

Description:

Aspirin and clopidogrel for at least 6 months

Treatment:

Procedure: Percutaneous coronary intervention (PCI)