Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR

NCT01761656 | Unknown Phase 2 DMC

• 1 other identifier: ARMYDA-IMR 01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• perioperative myocardial infarction

  1 month after PCI

Secondary Outcomes (2)

• major adverse cardiac events (MACE) 1 month after PCI

  1 month

• mortality 1 month after PCI

  1 month

Study Arms (2)

loading dose atorvastatin

EXPERIMENTAL

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

conventional dose atorvastatin

ACTIVE COMPARATOR

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

Interventions

loading dose atorvastatin DRUG

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.

Also known as: lipitor

loading dose atorvastatin

conventional dose atorvastatin DRUG

For conventional dose atorvastatin intervention, patients will be treated with 20 mg atorvastatin (lipitor) 12 hours before PCI and then 20mg/d after PCI.

Also known as: lipitor

conventional dose atorvastatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Xiangtan Clinical College affiliated to Central South University

Xiangtan, Hunan, 411100, China

RECRUITING

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction; Cardiovascular Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Zhishan SUN, doctor

  Central South University

  STUDY CHAIR

Central Study Contacts

Zhishan SUN, doctor

CONTACT

+8613637405536; clinton_sun@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Central South university

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 7, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

CN (1)