Trial Outcomes & Findings for Efficacy of Statins In Prevention of CIN (NCT NCT01071993)
NCT ID: NCT01071993
Last Updated: 2017-12-04
Results Overview
Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \> 0.5 mg/dL or \>25% Increase From Baseline at 24 \& at 48 Hours
TERMINATED
NA
21 participants
48 hours
2017-12-04
Participant Flow
Participants were recruited and signed consent. No drugs were supplied to participants. Study sponsor could not provide study drugs to participants due to cost restraints.
Prior to assigning participants to specific arms of the protocol, site was informed that the study drug was no longer available.
Participant milestones
| Measure |
Atorvastatin
atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
|
Placebo
placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Statins In Prevention of CIN
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 48 hoursPopulation: Participants signed consent; however, study was terminated prior to randomization
Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \> 0.5 mg/dL or \>25% Increase From Baseline at 24 \& at 48 Hours
Outcome measures
Outcome data not reported
Adverse Events
Atorvastatin
Placebo
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