Coronary Artery Disease
Conditions
Keywords
atorvastatin, clopidogrel, percutaneous intervention, periprocedural myonecrosis
Brief 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.
Interventions
DRUGAtorvastatin
Atorvastatin 80mg po given one time before PCI in cath lab.
Sponsors
National Center for Research Resources (NCRR)
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing revascularization for significant coronary artery disease * age range 21-85 years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Periprocedural Myonecrosis | 16-24 hours post PCI |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Atorvastatin Patients do not receive Atorvastatin prior to PCI in cath lab | 32 |
| Atorvastatin Atorvastatin 80mg po given prior to PCI in cath lab
Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab. | 28 |
| Total | 60 |
Baseline characteristics
| Characteristic | No Atorvastatin | Atorvastatin | Total |
|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 8 | 62.6 years STANDARD_DEVIATION 10 | 61.9 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 25 Participants | 22 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 28 |
| serious Total, serious adverse events | 0 / 32 | 0 / 28 |
Outcome results
Primary
Periprocedural Myonecrosis
Time frame: 16-24 hours post PCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Atorvastatin | Periprocedural Myonecrosis | 17 participants |
| Atorvastatin | Periprocedural Myonecrosis | 15 participants |
p-value: 0.97Chi-squared