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Effect of High Loading Dose of Atorvastatin in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention on Microvascular Perfusion Measured by Index of Microvascular Resistance

Effect of High Loading Dose of Atorvastatin in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention on Microvascular Perfusion Measured by Index of Microvascular Resistance

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000019505
Enrollment
64
Registered
2015-01-15
Start date
2014-01-15
Completion date
2014-12-15
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

Background: Statin (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors), given before percutaneous coronary intervention (PCI) was proven to reduce Major Cardiovascular Events (MCE) in patient with stable angina as well as acute coronary syndromes through its pleiotropic effect. Nevertheless, the debate regarding statin administration before primary PCI (PPCI) in STEMI patients is still on the rise. The aim of this study is to establish therapeutic effect of high dose atorvastatin (80 mg) and placebo before primary PCI on microvascular perfusion in STEMI patient using index of microcirculatory resistance (IMR). IMR are specific and quantitative assessment of coronary microvascular dysfunction, reliable on-site predictors of short-term myocardial viability and left ventricle functional recovery of patients undergoing primary PCI for STEMI Methods: This study is a double blind randomized controlled trial. A high loading dose of atorvastatin (80 mg) or placebo was administered before PPCI. Samples were taken from the population of STEMI patients which underwent PPCI and meet inclusion and exclusion criteria. The primary end point of this study is IMR. After successful primary percutaneous coronary intervention, IMR was measured using a pressure-temperature sensor-tipped coronary guidewire.

Interventions

High loading dose of atorvastatin (80 mg) before primary PCI. Atorvastatin was given in oral tablet formulation immediately after patients was diagnosed as STEMI in emergency department and planned to do primary PCI

Sponsors

Suci Indriani
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

ST elevation minimal 0.1 mV in 2 concomittant ECG lead or new or presumably new LBBB

Exclusion criteria

Cardiogenic shock, respiratory distress, arrythmia, pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026