APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Procedure: Percutaneous coronary intervention (PCI) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 6-month Reocclusion [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography
- Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.
| Enrollment: | 49 |
| Study Start Date: | January 2005 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Procedure: Percutaneous coronary intervention (PCI)
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Other Name: bare metal stent placement
|
|
Dual antiplatelet therapy
Aspirin and clopidogrel for at least 6 months
|
Procedure: Percutaneous coronary intervention (PCI)
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Other Name: bare metal stent placement
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Netherlands | |
| Radboud University Nijmegen Medical Center | |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Principal Investigator: | Freek WA Verheugt, MD PhD | Radboud University Nijmegen Medical Center |
More Information
No publications provided
| Responsible Party: | Prof. Dr. F.W.A. Verheugt, Professor of Cardiology, Heartcenter, University Medical Center St. Radboud |
| ClinicalTrials.gov Identifier: | NCT00138034 History of Changes |
| Other Study ID Numbers: | APRICOT-3, 2003B257 |
| Study First Received: | August 29, 2005 |
| Results First Received: | February 20, 2012 |
| Last Updated: | April 25, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Heartcenter, University Medical Center St. Radboud:
|
Open infarct-related artery within 72 hours of thrombolysis |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013