The effect of combination of rosuvastatin and fenofibrate and metoprolol on the coronary atheroma plaque progression detected by multi-detector spiral computed tomography

The combination of rosuvastatin and fenofibrate and metoprolol can impede coronary atheroma plaque progression detected by multi-detector spiral computed tomography

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000394943

Enrollment

520

Registered

2011-04-14

Start date

2011-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To clarify the effect of combination of rosuvastatin and fenofibrate and metoprolol on the coronary atheroma plaque progression and plaque stabilization, and elucidated the possibility of this combination to reduce cardiovascular risk further.

Interventions

There are 3 intervention arms in this study. rosuvastatin 10 mg/day plus fenofibrate 80 mg/day plus metoprolol 50mg /day for 6 months rosuvastatin 10 mg/day plus fenofibrate 80 mg/day for 6 months rosuvastatin 10 mg/day plus metoprolol 50mg/day for 6 months. All of the drugs are taken as oral capsules or tablets.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1.no chest pain or atypical chest pain 2.mild to moderate coronary atheroma plaque by multidetector computed tomography (MDCT) 3. diameter narrowing is less than 50% 4. low-density lipoprotein cholesterol(LDL-C)>100mg/dl, triglyceride(TG)>150 mg/dL

Exclusion criteria

known coronary artery disease; previous coronary revascularization; signs or symptoms suggesting ischemia and coronary revascularization needed in a short time; current lipid-lowering pharmacotherapy; known genetic form of dyslipidemia; creatinine > 1.5 mg/dL; ALT or AST>40u/L; fasting serum TG> 500 mg/dL; inability to perform MDCT; uncontrolled hypertension; decompensated heart failure (class IV); known pregnancy; combined condition decreasing life expectancy; heart rate<60 beats/min; sick sinus syndrome; atrioventricular block over 2 degree type 2

Outcome results