TerminatedNCT00979940ESTATEUpdated Sep 22, 2015Results posted

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

An interventional study of Atorvastatin in Coronary Artery Disease, sponsored by Indiana University School of Medicine. Terminated at 2 sites in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-09-22.

Sponsored by Indiana University School of Medicine · Not applicable, Interventional, and Treatment

Why this study was terminated

Slower than anticipated enrollment for pilot study.

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 21 Years to 85 Years
Sex: All

Study summary

This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.

Conditions studied

Coronary Artery Disease

Browse trials for

Coronary Artery Disease 5,598

Keywords

atorvastatin
clopidogrel
percutaneous intervention
periprocedural myonecrosis

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 60 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

patients undergoing revascularization for significant coronary artery disease
age range 21-85 years

Exclusion criteria

Exclusion Criteria:

non-STEMI, STEMI
cancer
renal failure with creatinine>3.0mg/dl
liver cirrhosis
lymphoproliferative disorder
pregnancy
thrombocytopenia\<150'000
coagulopathy (INR>1.5)
abnormal liver function tests
illicit drug use
history of statin intolerance
history of rhabdomyolysis
planned use of Glycoprotein IIb/IIIa inhibitors during PCI
current therapy with atorvastatin, pravastatin, lovastatin, fluvastatin, or rosuvastatin

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

No intervention
No atorvastatin
Patients do not receive Atorvastatin prior to PCI in cath lab
Experimental
atorvastatin
Atorvastatin 80mg po given prior to PCI in cath lab
Drug: Atorvastatin

Interventions

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

What researchers measure

Primary outcomes

Periprocedural Myonecrosis
Time frame: 16-24 hours post PCI

Results

Posted Sep 22, 2015

Participant flow

Participant flow — Overall Study
Milestone	No Atorvastatin	Atorvastatin
Started	32	28
Completed	32	28
Not completed	0	0

Outcome measures

PrimaryPeriprocedural Myonecrosis

Time frame:: 16-24 hours post PCI
Reported as:: Number · participants

Periprocedural Myonecrosis
participants	No Atorvastatin	Atorvastatin
Periprocedural Myonecrosis	17	15

Statistical analysis

No Atorvastatin vs Atorvastatin · Chi-squared · p = 0.97

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
No Atorvastatin	—	0/32 (0%)	0/32 (0%)
Atorvastatin	—	0/28 (0%)	0/28 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	No Atorvastatin	Atorvastatin	Total
Mean	61.4 ± 8	62.6 ± 10	61.9 ± 9

Sex: Female, Male
Sex: Female, Male(Participants)	No Atorvastatin	Atorvastatin	Total
Female	7	6	13
Male	25	22	47

Study locations

2 sites

Methodist Hospital
Indianapolis, Indiana 46202, United States
Wishard Hospital
Indianapolis, Indiana 46202, United States

References and documents

Publications

Kreutz RP, Breall JA, Sinha A, von der Lohe E, Kovacs RJ, Flockhart DA. Simultaneous administration of high-dose atorvastatin and clopidogrel does not interfere with platelet inhibition during percutaneous coronary intervention. Clin Pharmacol. 2016 Jun 3;8:45-50. doi: 10.2147/CPAA.S98790. eCollection 2016. PubMed 27350760 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00979940
Lead sponsor: Indiana University School of Medicine
Collaborators: National Center for Research Resources (NCRR)
Responsible party: Sponsor
First posted: Sep 18, 2009
Start date: Nov 2008
Primary completion: Jun 2014
Completion: Aug 2014
Results posted: Sep 22, 2015
Last update: Sep 22, 2015

Study contacts

Rolf Kreutz, MD

principal investigator · Indiana University School of Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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