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

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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
Sponsor:
Information provided by (Responsible Party):
Zhishan SUN, Central South University

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. perioperative myocardial infarction [ Time Frame: 1 month after PCI ]

Secondary Outcome Measures :
  1. major adverse cardiac events (MACE) 1 month after PCI [ Time Frame: 1 month ]
  2. mortality 1 month after PCI [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Zhishan SUN, doctor +8613637405536 ext +8673158211893 clinton_sun@163.com

Locations
China, Hunan
Xiangtan Clinical College affiliated to Central South University Recruiting
Xiangtan, Hunan, China, 411100
Contact: Zhishan SUN, doctor    +8613637405536 ext +8673158211893    clinton_sun@163.com   
Sponsors and Collaborators
Central South University
Investigators
Study Chair: Zhishan SUN, doctor Central South University

Responsible Party: Zhishan SUN, Central South university, Central South University
ClinicalTrials.gov Identifier: NCT01761656     History of Changes
Other Study ID Numbers: ARMYDA-IMR 01
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Zhishan SUN, Central South University:
stable angina
unstable angina
acute non-ST-segment elevation myocardial infarction
PCI
perioperative myocardial infarction
major adverse cardiac events

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Angina Pectoris
Angina, Stable
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors