APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3
A Multicenter Randomized Trial in the Prevention of Reocclusion Following Successful Thrombolysis for Suspected Acute Myocardial Infarction: An Invasive Versus a Conservative Strategy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Percutaneous coronary intervention (PCI)
Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months
|
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Other Names:
|
|
Other: Dual antiplatelet therapy
Aspirin and clopidogrel for at least 6 months
|
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-month Reocclusion
Time Frame: 6 months
|
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
Time Frame: 6 months
|
The occurence of any one of the above mentioned outcome measures.
Only the first event per patient is counted.
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Freek WA Verheugt, MD PhD, Radboud University Nijmegen Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APRICOT-3
- 2003B257 (Other Identifier: Netherlands Heart Foundation)
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