Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR (ARMYDA-IMR)

Central South University

Status and phase

Unknown

Phase 2

Conditions

Unstable Angina

Stable Angina

Acute Non-ST-segment Elevation Myocardial Infarction

Treatments

Drug: loading dose atorvastatin

Drug: conventional dose atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01761656

ARMYDA-IMR 01

Details and patient eligibility

About

The purpose of this study is to determine whether preoperative loading dose atorvastatin can prevent perioperative myocardial infarction during angiography and main adverse cardiac events 1 month after operation in stable angina, unstable angina and acute non-ST-segment elevation myocardial infarction patients undergoing elective coronary angiography and PCI, and determine whether its mechanisms are associated with microcirculation resistance.

Full description

With 20 years of popularity of the clinical applications of percutaneous coronary intervention (PCI), increasing attention has been paid to postoperative myocardial injury (MI) after PCI. NAPLES II1 and ARMYDA2Studies have shown that loading dose statin therapy before PCI for ACS patients can reduce perioperative myocardial infarction and major adverse cardiac events (MACE) and mortality 1 year after PCI. The core mechanism about the effects of statins on the clinical outcomes above-mentioned, which can not been completely explained by the lipid-lowering effect, so far have not been discovered in previous studies. Thus the interest of some researchers turned to the other point of view, such as coronary microcirculation. MI after PCI is a kind of non-ST-segment elevation myocardial infarction (NSTEMI) related to coronary microcirculation, which can not been detected by coronary angiography, but can be detected by index of microcirculatory resistance (IMR) examination.

In this study, we will recruit stable angina, unstable angina and acute non-ST-segment elevation myocardial infarction patients who have been confirmed by coronary angiography. At the time of enrollment, patients will be randomly assigned to loading dose group (atorvastatin 80 mg 12 hours before PCI and 40 mg 2 hours before PCI and then 20mg/d after PCI) or control group (atorvastatin 20 mg 12 hours before PCI and then 20mg/d after PCI). When PCI is performed, index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 month.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with stable angina
Patients with unstable angina patients
Patients with acute non STsegment elevation myocardial infarction
Patients willing to accept the need regular follow-up of this study
Patients 18-75 years of age
Patients who signed an informed consent form

Exclusion criteria

ST segment elevation acute myocardial infarction
Emergency coronary angiography in patients
Patients with abnormal liver function
Heavily calcified, distortions coronary lesions
LVEF <30% of patients
eGFR<30ml/min/1.73 Square meters
Liver disease or a history of muscle disease

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

loading dose atorvastatin

Experimental group

Description:

For the arm of loading dose atorvastatin, patients will be treated with 80 mg atorvastatin 12 hours before PCI and 40 mg atorvastatin 2 hours before PCI and then 20mg/d after PCI.

Treatment:

Drug: loading dose atorvastatin

conventional dose atorvastatin

Active Comparator group

Description:

For the arm of conventional dose atorvastatin, patients will be treated with 20 mg atorvastatin 12 hours before PCI and then 20mg/d after PCI.

Treatment:

Drug: conventional dose atorvastatin