Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI (ISCAP)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-ST Segment Elevation Myocardial Infarction Unstable Angina Pectoris Stable Angina Pectoris |
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: | Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention(PCI) |
- 30-day MACEs after PCI [ Time Frame: 30 days after PCI ] [ Designated as safety issue: No ]30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
- Post-procedural change of inflammatory biomarkers (hs-CRP) [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]Post-procedural change of inflammatory biomarkers (hs-CRP)
- Morbidity of CIN [ Time Frame: 48 hours after PCI ] [ Designated as safety issue: No ]Morbidity of CIN
- Elevation of ALT, AST and CK [ Time Frame: 6 months after PCI ] [ 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.
- Adverse events [ Time Frame: 6 months after PCI ] [ 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 after PCI ] [ Designated as safety issue: No ]Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.
| Enrollment: | 2884 |
| Study Start Date: | June 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Intensive statin therapy
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
Other Name: Liptor
|
|
Usual care
Usual care, but 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
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China | |
| Division of Cardiology, Peking University First Hospital | |
| Beijing, China, 10034 | |
| Principal Investigator: | Yong Huo, MD | Peking University First Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Yong Huo, Director, Department of cardiology, Peking University First Hospital |
| ClinicalTrials.gov Identifier: | NCT01293097 History of Changes |
| Other Study ID Numbers: | ISCAP |
| Study First Received: | February 9, 2011 |
| Last Updated: | April 28, 2013 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Angina Pectoris Angina, Unstable Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Myocardial Infarction Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Arteriosclerosis |
Arterial Occlusive Diseases 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 June 18, 2013