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

This study is currently recruiting participants.
Verified January 2013 by Central South University
Sponsor:
Information provided by (Responsible Party):
Zhishan SUN, Central South University
ClinicalTrials.gov Identifier:
NCT01761656
First received: December 28, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Stable Angina
Unstable Angina
Acute Non-ST-segment Elevation Myocardial Infarction
 Drug: loading dose atorvastatin
Drug: conventional dose atorvastatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

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

Further study details as provided by Central South University:

Primary Outcome Measures:
  • perioperative myocardial infarction [ Time Frame: 1 month after PCI ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • major adverse cardiac events (MACE) 1 month after PCI [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • mortality 1 month after PCI [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Zhishan SUN, Central South university, Central South University
ClinicalTrials.gov Identifier: NCT01761656     History of Changes
Other Study ID Numbers: ARMYDA-IMR 01
Study First Received: December 28, 2012
Last Updated: January 7, 2013
Health Authority: China: Ministry of Health

Keywords provided by 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:
Angina Pectoris
Angina, Unstable
Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
 Pathologic Processes
Necrosis
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013