Pilot study of low- vs. high-dose Rosuvastatin in minor heart attack patients and healthy controls: assessment of skin microvascular blood flow.

Does one week of 10mg vs. 40mg Rosuvastatin improve skin microvascular blood flow in stable non-ST segment elevation myocardial infarction (NSTEMI) and healthy controls? A pilot study.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000575730

Enrollment

Registered

2013-05-21

Start date

2016-01-01

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

The cardiovascular system is made up of the heart, blood vessels and blood, and is responsible for the delivery of nutrients and removal of waste from the body. Blood flow is primarily regulated by the very small blood vessels. Examination of the skin blood vessels using laser Doppler flowmetry is an easy method that provides an index of global microvasculature function. Statins are a class of drug that reduce cardiovascular events and mortality. In addition to lowering cholesterol levels, statins demonstrate a number of other effects that protect the heart. After a heart attack, statins improve patient outcomes by improving the function of the large and small blood vessels. Rosuvastatin is more potent and effective than other statins. However, no studies have investigated the effect of Rosuvastatin on the very small skin blood vessels in patients who have had a minor heart attack. This pilot study aims to evaluate the effect of 1-week low- vs. high-dose Rosuvastatin therapy on very small blood vessel function in patients who present with a minor heart attack compared to a healthy population. We hypothesise that 1-week high-dose Rosuvastatin in minor heart attack patients and healthy controls does not improve the function of the very small blood vessels when compared to 1-week low-dose Rosuvastatin.

Interventions

40mg Rosuvastatin (Crestor) tablet administered orally once daily in the morning for 7 days. Drug tablet return will be used to monitor adherence.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

55 Years to 70 Years

Healthy volunteers

Inclusion criteria

Post-menopausal women (STRAW +10 definition) and age-matched men NSTEMI group only - Evidence of NSTEMI: Electrocardiographic ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or anginal equivalent)

Exclusion criteria

Current statin therapy Skin pathology on volar forearms Previous myocardial infarction or coronary artery bypass grafting Known serious or hypersensitivity reactions to statin, anti-platelet agents (aspirin or clopidogrel), or heparin Cardiogenic shock or symptomatic hypotension or sitting SBP < 95mmHg Congestive heart failure (NYHA Class III or IV) or LVEF < 35% Inability to provide informed consent Non-English speaking

Outcome results