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Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI) (ESTATE)

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ClinicalTrials.gov Identifier: NCT00979940
Recruitment Status : Terminated (Slower than anticipated enrollment for pilot study.)
First Posted : September 18, 2009
Results First Posted : September 22, 2015
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Drug: Atorvastatin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
No Atorvastatin Patients do not receive Atorvastatin prior to PCI in cath lab
Atorvastatin

Atorvastatin 80mg po given prior to PCI in cath lab

Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab.


Participant Flow:   Overall Study
    No Atorvastatin   Atorvastatin
STARTED   32   28 
COMPLETED   32   28 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
No Atorvastatin Patients do not receive Atorvastatin prior to PCI in cath lab
Atorvastatin

Atorvastatin 80mg po given prior to PCI in cath lab

Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab.

Total Total of all reporting groups

Baseline Measures
   No Atorvastatin   Atorvastatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   28   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.4  (8)   62.6  (10)   61.9  (9) 
Gender 
[Units: Participants]
     
Female   7   6   13 
Male   25   22   47 


  Outcome Measures

1.  Primary:   Periprocedural Myonecrosis   [ Time Frame: 16-24 hours post PCI ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Rolf Kreutz
Organization: Indiana University School of Medicine
phone: 3179620500
e-mail: rkreutz@iu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00979940     History of Changes
Other Study ID Numbers: 0712-15
1470
First Submitted: September 17, 2009
First Posted: September 18, 2009
Results First Submitted: August 24, 2015
Results First Posted: September 22, 2015
Last Update Posted: September 22, 2015