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

This study has been completed.
Sponsor:
Collaborators:
Netherlands Heart Foundation
The Interuniversity Cardiology Institute of the Netherlands
Pfizer
Sanofi
Information provided by (Responsible Party):
Prof. Dr. F.W.A. Verheugt, Heartcenter, University Medical Center St. Radboud
ClinicalTrials.gov Identifier:
NCT00138034
First received: August 29, 2005
Last updated: April 25, 2012
Last verified: April 2012

August 29, 2005
April 25, 2012
January 2005
January 2010   (final data collection date for primary outcome measure)
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
6-month reocclusion
Complete list of historical versions of study NCT00138034 on ClinicalTrials.gov Archive Site
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.
1-year composite death, reinfarction, revascularization
Not Provided
Not Provided
 
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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
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
  • 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
    Intervention: Procedure: Percutaneous coronary intervention (PCI)
  • Dual antiplatelet therapy
    Aspirin and clopidogrel for at least 6 months
    Intervention: Procedure: Percutaneous coronary intervention (PCI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
February 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00138034
APRICOT-3, 2003B257
No
Prof. Dr. F.W.A. Verheugt, Heartcenter, University Medical Center St. Radboud
Heartcenter, University Medical Center St. Radboud
  • Netherlands Heart Foundation
  • The Interuniversity Cardiology Institute of the Netherlands
  • Pfizer
  • Sanofi
Principal Investigator: Freek WA Verheugt, MD PhD Radboud University Nijmegen Medical Center
Heartcenter, University Medical Center St. Radboud
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP