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| ID | Type | Description | Link |
|---|---|---|---|
| 2003B257 | Other Identifier | Netherlands Heart Foundation |
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| Name | Class |
|---|---|
| Netherlands Heart Foundation | OTHER |
| The Interuniversity Cardiology Institute of the Netherlands | OTHER_GOV |
| Pfizer | INDUSTRY |
| Sanofi |
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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.
Randomized controlled study of elective percutaneous coronary intervention (PCI) of an open culprit lesion after fibrinolysis for ST-elevation myocardial infarction (STEMI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous coronary intervention (PCI) | Active Comparator | Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months |
|
| Dual antiplatelet therapy | Other | Aspirin and clopidogrel for at least 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention (PCI) | Procedure | PCI with bare metal stent placement of the culprit lesion the in the infarct related artery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Freek WA Verheugt, MD PhD | Radboud University Nijmegen Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Center | Nijmegen | Gelderland | 6500 HB | Netherlands |
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Patients were included from 1 january 2005 until december 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Percutaeous Coronary Intervention (PCI) | Stenting of culprit lesion followed by dual antiplatelet therapy |
| FG001 | Conservative Treatment | Conservative treatment of culprit lesion with dual antiplatelet therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Percutaeous Coronary Intervention (PCI) | Stenting of culprit lesion followed by dual antiplatelet therapy |
| BG001 | Conservative Treatment | Conservative treatment of culprit lesion with dual antiplatelet therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 6-month Reocclusion | Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography | Posted | Number | participants | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Percutaeous Coronary Intervention (PCI) | Stenting of culprit lesion followed by dual antiplatelet therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| intracerebral bleeding | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Doctor F.W.A. Verheugt | Radboud University Medical Center Nijmegen | +31(0)24-3614533 | f.verheugt@cardio.umcn.nl |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| INDUSTRY |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 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. | Posted | Number | participants | 6 months |
|
|
|
| 1 |
| 26 |
| 0 |
| 26 |
| EG001 | Conservative Treatment | Conservative treatment of culprit lesion with dual antiplatelet therapy | 0 | 23 | 0 | 23 |
Freek W.A. Verheugt
has to following potential conflict of interest:
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D019060 | Minimally Invasive Surgical Procedures |