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
Results First Received: February 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myocardial Infarction
Intervention: Procedure: Percutaneous coronary intervention (PCI)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were included from 1 january 2005 until december 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Percutaeous Coronary Intervention (PCI) Stenting of culprit lesion followed by dual antiplatelet therapy
Conservative Treatment Conservative treatment of culprit lesion with dual antiplatelet therapy

Participant Flow:   Overall Study
    Percutaeous Coronary Intervention (PCI)     Conservative Treatment  
STARTED     26     23  
COMPLETED     23     20  
NOT COMPLETED     3     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Percutaeous Coronary Intervention (PCI) Stenting of culprit lesion followed by dual antiplatelet therapy
Conservative Treatment Conservative treatment of culprit lesion with dual antiplatelet therapy
Total Total of all reporting groups

Baseline Measures
    Percutaeous Coronary Intervention (PCI)     Conservative Treatment     Total  
Number of Participants  
[units: participants]
  26     23     49  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     15     31  
>=65 years     10     8     18  
Age  
[units: years]
Mean ± Standard Deviation
  60  ± 12     59  ± 13     59  ± 12  
Gender  
[units: participants]
     
Female     4     4     8  
Male     22     19     41  
Region of Enrollment  
[units: participants]
     
Netherlands     20     20     40  
Austria     2     1     3  
Australia     4     2     6  



  Outcome Measures
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1.  Primary:   6-month Reocclusion   [ Time Frame: 6 months ]

2.  Secondary:   Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Professor Doctor F.W.A. Verheugt
Organization: Radboud University Medical Center Nijmegen
phone: +31(0)24-3614533
e-mail: f.verheugt@cardio.umcn.nl


No publications provided


Responsible Party: Prof. Dr. F.W.A. Verheugt, 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)