Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR (ARMYDA-IMR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01761656|
Recruitment Status : Unknown
Verified January 2013 by Zhishan SUN, Central South University.
Recruitment status was: Recruiting
First Posted : January 7, 2013
Last Update Posted : January 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Stable Angina Unstable Angina Acute Non-ST-segment Elevation Myocardial Infarction||Drug: loading dose atorvastatin Drug: conventional dose atorvastatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||February 2014|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761656
|Contact: Zhishan SUN, doctor||+8613637405536 ext +firstname.lastname@example.org|
|Xiangtan Clinical College affiliated to Central South University||Recruiting|
|Xiangtan, Hunan, China, 411100|
|Contact: Zhishan SUN, doctor +8613637405536 ext +8673158211893 email@example.com|
|Study Chair:||Zhishan SUN, doctor||Central South University|