Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01372839
First received: June 10, 2011
Last updated: June 11, 2011
Last verified: July 2010
  Purpose

Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.


Condition Intervention Phase
Myocardial Infarction
Unstable Angina
Drug: Atorvastatin
Drug: Statin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • 30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post-procedural change of inflammatory biomarkers (hs-CRP) [ Time Frame: 24h ] [ Designated as safety issue: No ]
  • Morbidity of CIN [ Time Frame: 48h ] [ Designated as safety issue: No ]
  • Elevation of ALT, AST and CK [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Proportion of patients who experience at least once AST>3UNL,ALT>3UNL or CK>5UNL after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>UNL after initiation of study treatment.

  • Number of Participants with Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events

  • Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.

  • serum adiponectin concentration [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2010
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin
80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
Drug: Atorvastatin
Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
Usual care
statin dose should not be higher than that described in exclusion criteria.
Drug: Statin
Usual care, but statin dose should not be higher than that described in exclusion criteria

Detailed Description:

This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-85 years old
  • Patients with clinical diagnosis of ACS
  • Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

  • Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
  • LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
  • Endstage congestive heart failure, or LVEF < 30%
  • Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
  • Myopathy or increased creatine kinase (CK>2 UNL)
  • Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L)
  • Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
  • Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
  • Pregnancy, lactation, or child bearing potential women without any effective contraception
  • Accompanied with malignant disease or other disease, which cause life expectancy < 6 months
  • Participating in other interventional clinical trails using drugs or devices
  • Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372839

Contacts
Contact: Ling Tao, M.D Ph.D +86-15002955798 lingtao2006@gmail.com

Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ling Tao, M.D Ph.D    +86-15002955798    lingtao2006@gmail.com   
Principal Investigator: Ling Tao, M.D Ph.D         
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Yong Huo, MD Division of Cardiology, Peking University First Hospital
  More Information

No publications provided

Responsible Party: Ling Tao, Department of Cardiology of Xijing Hospital; Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01372839     History of Changes
Other Study ID Numbers: xj050511
Study First Received: June 10, 2011
Last Updated: June 11, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Myocardial Infarction
Unstable Angina

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
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
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014