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
Recruitment status was Recruiting
Sponsor:
Xijing Hospital
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01372839
First received: June 10, 2011
Last updated: June 11, 2011
Last verified: July 2010
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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
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 Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013