Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR

Stable Angina Clinical Trial

— ARMYDA-IMR  

Official title:

Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01761656
• Other study ID #: ARMYDA-IMR 01
• Status: Recruiting
• Phase: Phase 2
• First received: December 28, 2012
• Last updated: January 7, 2013
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: January 2013
• Source: Central South University
• Contact: Zhishan SUN, doctor
• Phone: +8613637405536
• Email: clinton_sun[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Non-ST-segment Elevation Myocardial Infarction
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Stable Angina
• Unstable Angina

Intervention

Drug:
• loading dose atorvastatin
For loading dose atorvastatin intervention, patients will be treated with 80 mg atorvastatin (lipitor) 12 hours before PCI and 40 mg atorvastatin (lipitor) 2 hours before PCI and then 20mg/d after PCI.
• conventional dose atorvastatin
For conventional dose atorvastatin intervention, patients will be treated with 20 mg atorvastatin (lipitor) 12 hours before PCI and then 20mg/d after PCI.

Locations

Country	Name	City	State
China	Xiangtan Clinical College affiliated to Central South University	Xiangtan	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative myocardial infarction		1 month after PCI	Yes
Secondary	major adverse cardiac events (MACE) 1 month after PCI		1 month	Yes
Secondary	mortality 1 month after PCI		1 month	Yes