Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR (ARMYDA-IMR)
Primary Purpose
Stable Angina, Unstable Angina, Acute Non-ST-segment Elevation Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
loading dose atorvastatin
conventional dose atorvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Stable Angina focused on measuring stable angina, unstable angina, acute non-ST-segment elevation myocardial infarction, PCI, perioperative myocardial infarction, major adverse cardiac events
Eligibility Criteria
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
Sites / Locations
- Xiangtan Clinical College affiliated to Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
loading dose atorvastatin
conventional dose atorvastatin
Arm 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.
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.
Outcomes
Primary Outcome Measures
perioperative myocardial infarction
Secondary Outcome Measures
major adverse cardiac events (MACE) 1 month after PCI
mortality 1 month after PCI
Full Information
NCT ID
NCT01761656
First Posted
December 28, 2012
Last Updated
January 7, 2013
Sponsor
Central South University
1. Study Identification
Unique Protocol Identification Number
NCT01761656
Brief Title
Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR
Acronym
ARMYDA-IMR
Official Title
Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Unstable Angina, Acute Non-ST-segment Elevation Myocardial Infarction
Keywords
stable angina, unstable angina, acute non-ST-segment elevation myocardial infarction, PCI, perioperative myocardial infarction, major adverse cardiac events
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
loading dose atorvastatin
Arm Type
Experimental
Arm 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.
Arm Title
conventional dose atorvastatin
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
loading dose atorvastatin
Other Intervention Name(s)
lipitor
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
conventional dose atorvastatin
Other Intervention Name(s)
lipitor
Intervention Description
For conventional dose atorvastatin intervention, patients will be treated with 20 mg atorvastatin (lipitor) 12 hours before PCI and then 20mg/d after PCI.
Primary Outcome Measure Information:
Title
perioperative myocardial infarction
Time Frame
1 month after PCI
Secondary Outcome Measure Information:
Title
major adverse cardiac events (MACE) 1 month after PCI
Time Frame
1 month
Title
mortality 1 month after PCI
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishan SUN, doctor
Phone
+8613637405536
Ext
+8673158211893
Email
clinton_sun@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishan SUN, doctor
Organizational Affiliation
Central South University
Official's Role
Study Chair
Facility Information:
Facility Name
Xiangtan Clinical College affiliated to Central South University
City
Xiangtan
State/Province
Hunan
ZIP/Postal Code
411100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhishan SUN, doctor
Phone
+8613637405536
Ext
+8673158211893
Email
clinton_sun@163.com
12. IPD Sharing Statement
Learn more about this trial
Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR
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