Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138034
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2005-08-29
Brief Title:
APRICOT-3 Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3
Sponsor:
Heartcenter University Medical Center St Radboud
Organization:
Heartcenter University Medical Center St Radboud
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
Randomized controlled study of elective percutaneous coronary intervention PCI of an open culprit lesion after fibrinolysis for ST-elevation myocardial infarction STEMI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2003B257 | OTHER | Netherlands Heart Foundation | None |