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

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ClinicalTrials.gov Identifier: NCT00138034
Recruitment Status : Completed
First Posted : August 30, 2005
Results First Posted : April 19, 2012
Last Update Posted : April 30, 2012
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

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 30, 2005
Results First Submitted Date  ICMJE February 20, 2012
Results First Posted Date  ICMJE April 19, 2012
Last Update Posted Date April 30, 2012
Study Start Date  ICMJE January 2005
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
6-month Reocclusion
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
1-year composite death, reinfarction, revascularization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3
Official Title  ICMJE A Multicenter Randomized Trial in the Prevention of Reocclusion Following Successful Thrombolysis for Suspected Acute Myocardial Infarction: An Invasive Versus a Conservative Strategy
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2012)
49
Original Enrollment  ICMJE
 (submitted: August 29, 2005)
400
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00138034
Other Study ID Numbers  ICMJE APRICOT-3
2003B257 ( Other Identifier: Netherlands Heart Foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. F.W.A. Verheugt, Heartcenter, University Medical Center St. Radboud
Study Sponsor  ICMJE Heartcenter, University Medical Center St. Radboud
Collaborators  ICMJE
  • Netherlands Heart Foundation
  • The Interuniversity Cardiology Institute of the Netherlands
  • Pfizer
  • Sanofi
Investigators  ICMJE
Principal Investigator: Freek WA Verheugt, MD PhD Radboud University Nijmegen Medical Center
PRS Account Heartcenter, University Medical Center St. Radboud
Verification Date April 2012

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