Trial Outcomes & Findings for Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention (NCT NCT00588471)

Results Overview

The hsCRP test evaluates vascular inflammation. People with higher hsCRP values have the highest risk of cardiovascular disease, and those with lower values have less of a risk. The American Heart Association and U.S. Centers for Disease Control and Prevention have defined risk groups as follows: Low risk: less than 1.0 mg/L Average risk: 1.0 to 3.0 mg/L High risk: above 3.0 mg/L

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

baseline, within 24 hours post percutaneous coronary intervention

Results posted on

2012-11-08

Participant Flow

Subjects were enrolled at the Mayo Clinic in Rochester, MN from 2002 until 2008.

66 subjects signed informed consent, but 9 subjects had to have the PCI procedure too quickly, and could not participate in the study.

Participant milestones

Participant milestones
Measure	Simvastatin Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.	Placebo Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
Overall Study STARTED	28	29
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simvastatin n=28 Participants Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.	Placebo n=29 Participants Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	29 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, within 24 hours post percutaneous coronary intervention

Population: The study was terminated early because not enough subjects could be recruited.

The hsCRP test evaluates vascular inflammation. People with higher hsCRP values have the highest risk of cardiovascular disease, and those with lower values have less of a risk. The American Heart Association and U.S. Centers for Disease Control and Prevention have defined risk groups as follows: Low risk: less than 1.0 mg/L Average risk: 1.0 to 3.0 mg/L High risk: above 3.0 mg/L

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, within 24 hours post percutaneous coronary intervention

Population: The study was terminated early because not enough subjects could be recruited.

The EndoPAT is a noninvasive test that involves putting probes on the index fingers of both hands and evaluating the blood flow to one hand before and after inflating a blood pressure cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will now show no blood flow, while the sensor on the opposite index finger will continue to display your normal blood flow level. After several minutes, the blood pressure cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, however, the blood vessels are unhealthy. The results are reported as the "Endoscore" (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart.

Outcome measures

Outcome data not reported

Adverse Events

Simvastatin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Simvastatin n=28 participants at risk Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.	Placebo n=29 participants at risk Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
General disorders Subject could not tolerate the Blood Pressure Cuff	3.6% 1/28 • Number of events 1 • All adverse events will be carefully monitored while the subject is on the study medicine, within 24 hours after the coronary procedure.	0.00% 0/29 • All adverse events will be carefully monitored while the subject is on the study medicine, within 24 hours after the coronary procedure.

Additional Information

Dr. Amir Lerman

Mayo Clinic

Phone: 507-255-7760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place