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Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI (ISCAP)

Primary Purpose

Non-ST Segment Elevation Myocardial Infarction, Unstable Angina Pectoris, Stable Angina Pectoris

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
Statin
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ST Segment Elevation Myocardial Infarction

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 20-75 years old
  • Patients with clinical diagnosis of NSTE-ACS (unstable angina or NSTE acute myocardial infarction) or stable angina pectoris (SAP) scheduled for selective coronary angiography
  • Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

  • Patients presenting with ST-segment elevation acute myocardial infarction (STEMI) or high risk NSTE-ACS, warranting emergency coronary angiography:
  • Experienced STEMI within previous 30 days
  • Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pravastatin 40mg/d, fluvastatin 80mg/d or rosuvastatin 5mg/d ) in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
  • Anticipated repeated PCI within 6 months
  • 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)
  • White blood cell < 4×109/L or platelet < 100×109/L
  • 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

Sites / Locations

  • Division of Cardiology, Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Intensive statin therapy

Usual care

Arm Description

Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Usual care, but statin dose should not be higher than that described in exclusion criteria.

Outcomes

Primary Outcome Measures

30-day MACEs after PCI
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI

Secondary Outcome Measures

Post-procedural change of inflammatory biomarkers (hs-CRP)
Post-procedural change of inflammatory biomarkers (hs-CRP)
Morbidity of CIN
Morbidity of CIN
Elevation of ALT, AST and CK
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.
Adverse events
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
Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.

Full Information

First Posted
February 9, 2011
Last Updated
April 28, 2013
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01293097
Brief Title
Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI
Acronym
ISCAP
Official Title
Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention(PCI)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized, open label, controlled, parallel group study is designed to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis. The goal is to set up an optimized protocol for peri-PCI statin treatment in Chinese CHD patients. Safety will also be observed.
Detailed Description
The study objective is to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis. 2160 patients with non-ST segment elevated acute coronary syndrome (ACS)or stable angina pectoris (SAP) scheduled for selective PCI are randomized into two groups. The study group is given atorvastatin 80 mg/d×2d before PCI while the control group receives usual care. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. After PCI procedure, the study group is given atorvastatin 40mg/d until 30 days after PCI while the control group receive usual care. The last visit will be at 6 months after PCI. Patients data such as troponin, CK-MB, Scr, CCR, ALT, AST before and after procedure will be recorded. 1100 effective patients will be finally enrolled. The study will be conducted at about 54 centers in China. Data will be collected on 2,100 NSTE or SAP patients undergoing PCI. Primary outcome: MACE within 30 days after PCI. Secondary outcome: Post-procedural change of inflammatory biomarkers (hs-CRP); Morbidity of CIN; Proportion of patients who experience at least once AST > 3ULN，ALT > 3ULN or CK > 5ULN after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>ULN after initiation of study treatment; Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events; Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST Segment Elevation Myocardial Infarction, Unstable Angina Pectoris, Stable Angina Pectoris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2884 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive statin therapy
Arm Type
Active Comparator
Arm Description
Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
Arm Title
Usual care
Arm Type
Other
Arm Description
Usual care, but statin dose should not be higher than that described in exclusion criteria.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Liptor
Intervention Description
Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
Intervention Type
Drug
Intervention Name(s)
Statin
Other Intervention Name(s)
Liptor, Zocor, Pravachol, Lescol
Intervention Description
Usual care, but statin dose should not be higher than that described in exclusion criteria
Primary Outcome Measure Information:
Title
30-day MACEs after PCI
Description
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
Time Frame
30 days after PCI
Secondary Outcome Measure Information:
Title
Post-procedural change of inflammatory biomarkers (hs-CRP)
Description
Post-procedural change of inflammatory biomarkers (hs-CRP)
Time Frame
24 hours after PCI
Title
Morbidity of CIN
Description
Morbidity of CIN
Time Frame
48 hours after PCI
Title
Elevation of ALT, AST and CK
Description
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.
Time Frame
6 months after PCI
Title
Adverse events
Description
Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events
Time Frame
6 months after PCI
Title
Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events
Description
Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.
Time Frame
6 months after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20-75 years old Patients with clinical diagnosis of NSTE-ACS (unstable angina or NSTE acute myocardial infarction) or stable angina pectoris (SAP) scheduled for selective coronary angiography Evidence of a personally signed and dated informed consent document Exclusion Criteria: Patients presenting with ST-segment elevation acute myocardial infarction (STEMI) or high risk NSTE-ACS, warranting emergency coronary angiography: Experienced STEMI within previous 30 days Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pravastatin 40mg/d, fluvastatin 80mg/d or rosuvastatin 5mg/d ) in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment. Anticipated repeated PCI within 6 months 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) White blood cell < 4×109/L or platelet < 100×109/L 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Huo, MD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Peking University First Hospital
City
Beijing
ZIP/Postal Code
10034
Country
China

12. IPD Sharing Statement

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Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI

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