Trial Outcomes & Findings for Effects of Atorvastatin on Myonecrosis (NCT NCT00344019)

Last Updated: 2018-01-02

Results Overview

As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

97 participants

Primary outcome timeframe

24 hours

Results posted on

2018-01-02

Participant Flow

Patients presenting to cath lab for angiogram with unstable angina were approached for participation. If patients agreed to participate, blood was drawn for laboratory evaluation of cardiac enzymes. If enzymes elevated, patient unable to continue participation. Patients proceeded to angiogram as planned. If no PCI performed, patient excluded.

97 patients were consented to participate but 74 of them were screen failed afterward due to not meeting angiographic, laboratory or other inclusion criteria. Hence, patients who were screened, but did not complete the study, were not considered enrolled

Participant milestones

Participant milestones
Measure	Atorvastatin 80 mg 80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI	Placebo Oral Tablet placebo on average of 2-4 hours pre angio/PCI for ACS Placebo Oral Tablet: placebo pre-PCI for ACS	Screening Patients that signed consent to participate. Of 97 patients that consented, only 23 completed the study. 74 patients did not continue likely due to no PCI indicated at time of angiogram. Individual subject data no longer available.
Overall Study STARTED	12	11	74
Overall Study COMPLETED	12	11	0
Overall Study NOT COMPLETED	0	0	74

Reasons for withdrawal

Reasons for withdrawal
Measure	Atorvastatin 80 mg 80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI	Placebo Oral Tablet placebo on average of 2-4 hours pre angio/PCI for ACS Placebo Oral Tablet: placebo pre-PCI for ACS	Screening Patients that signed consent to participate. Of 97 patients that consented, only 23 completed the study. 74 patients did not continue likely due to no PCI indicated at time of angiogram. Individual subject data no longer available.
Overall Study did not meet final inclusion criteria	0	0	74

Baseline Characteristics

Effects of Atorvastatin on Myonecrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atorvastatin 80 mg 80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI	Placebo Oral Tablet placebo on average of 2-4 hours pre angio/PCI for ACS Placebo Oral Tablet: placebo pre-PCI for ACS	Screening n=97 Participants \# patients who signed consent form prior to angiography. 74 did not continue, 23 completed the study. It is believed that most of the 74 did not continue due to the fact that no PCI was indicated at time of angiography	Total n=97 Participants Total of all reporting groups
Age, Customized Age >18 yrs	0 Participants n=5 Participants	0 Participants n=7 Participants	97 Participants n=5 Participants	97 Participants n=4 Participants
Sex: Female, Male Female	—	—	23 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	—	—	74 Participants n=5 Participants	74 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	—	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	—	96 Participants n=5 Participants	96 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	—	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	—	—	5 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	—	—	85 Participants n=5 Participants	85 Participants n=4 Participants
Race (NIH/OMB) More than one race	—	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	—	—	7 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment United States	—	—	97 participants n=5 Participants	97 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours

Other events: 0 other events

Deaths: 0 deaths

Screening

Serious events: 4 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Atorvastatin 80 mg 80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI	Placebo Oral Tablet placebo on average of 2-4 hours pre angio/PCI for ACS Placebo Oral Tablet: placebo pre-PCI for ACS	Screening n=97 participants at risk 97 patients screened 23 patients completed study in 1:1 randomization scheme. Randomization assignment not known. Data no longer available. No data analyzed
Cardiac disorders staged revasculalrization	— 0/0	— 0/0	1.0% 1/97 • Number of events 1
Respiratory, thoracic and mediastinal disorders increasing shortness of breath	— 0/0	— 0/0	1.0% 1/97 • Number of events 1
Nervous system disorders intracranial hemmorhage	— 0/0	— 0/0	1.0% 1/97 • Number of events 1
Cardiac disorders cardiorespiratory arrest	— 0/0	— 0/0	1.0% 1/97 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

BIDMC

Phone: 6176678800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place