Trial Outcomes & Findings for Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI) (NCT NCT00979940)
NCT ID: NCT00979940
Last Updated: 2015-09-22
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
16-24 hours post PCI
Results posted on
2015-09-22
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
28
|
|
Overall Study
COMPLETED
|
32
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI)
Baseline characteristics by cohort
| Measure |
No Atorvastatin
n=32 Participants
Patients do not receive Atorvastatin prior to PCI in cath lab
|
Atorvastatin
n=28 Participants
Atorvastatin 80mg po given prior to PCI in cath lab
Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 8 • n=99 Participants
|
62.6 years
STANDARD_DEVIATION 10 • n=107 Participants
|
61.9 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16-24 hours post PCIOutcome measures
| Measure |
No Atorvastatin
n=32 Participants
Patients do not receive Atorvastatin prior to PCI in cath lab
|
Atorvastatin
n=28 Participants
Atorvastatin 80mg po given prior to PCI in cath lab
Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab.
|
|---|---|---|
|
Periprocedural Myonecrosis
|
17 participants
|
15 participants
|
Adverse Events
No Atorvastatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Atorvastatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place