Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR (ARMYDA-IMR)
Recruitment status was: Recruiting
|Stable Angina Unstable Angina Acute Non-ST-segment Elevation Myocardial Infarction||Drug: loading dose atorvastatin Drug: conventional dose atorvastatin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR|
- perioperative myocardial infarction [ Time Frame: 1 month after PCI ]
- major adverse cardiac events (MACE) 1 month after PCI [ Time Frame: 1 month ]
- mortality 1 month after PCI [ Time Frame: 1 month ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: loading dose atorvastatin
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.
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.
Other Name: lipitor
Active Comparator: conventional dose atorvastatin
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.
Drug: 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.
Other Name: lipitor
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761656
|Contact: Zhishan SUN, doctor||+8613637405536 ext +email@example.com|
|Xiangtan Clinical College affiliated to Central South University||Recruiting|
|Xiangtan, Hunan, China, 411100|
|Contact: Zhishan SUN, doctor +8613637405536 ext +8673158211893 firstname.lastname@example.org|
|Study Chair:||Zhishan SUN, doctor||Central South University|