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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
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Atorvastatin Atorvastatin
Hide Arm/Group Description Patients do not receive Atorvastatin prior to PCI in cath lab

Atorvastatin 80mg po given prior to PCI in cath lab

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

Period Title: Overall Study
Started 32 28
Completed 32 28
Not Completed 0 0
Arm/Group Title No Atorvastatin Atorvastatin Total
Hide Arm/Group Description Patients do not receive Atorvastatin prior to PCI in cath lab

Atorvastatin 80mg po given prior to PCI in cath lab

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

Total of all reporting groups
Overall Number of Baseline Participants 32 28 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 28 participants 60 participants
61.4  (8) 62.6  (10) 61.9  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Female
7
  21.9%
6
  21.4%
13
  21.7%
Male
25
  78.1%
22
  78.6%
47
  78.3%
1.Primary Outcome
Title Periprocedural Myonecrosis
Hide Description [Not Specified]
Time Frame 16-24 hours post PCI
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Atorvastatin Atorvastatin
Hide Arm/Group Description:
Patients do not receive Atorvastatin prior to PCI in cath lab

Atorvastatin 80mg po given prior to PCI in cath lab

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

Overall Number of Participants Analyzed 32 28
Measure Type: Number
Unit of Measure: participants
17 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Atorvastatin, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Atorvastatin Atorvastatin
Hide Arm/Group Description Patients do not receive Atorvastatin prior to PCI in cath lab

Atorvastatin 80mg po given prior to PCI in cath lab

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

All-Cause Mortality
No Atorvastatin Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
No Atorvastatin Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
No Atorvastatin Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/28 (0.00%) 
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
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