Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI

NCT01293097 | Completed Phase 4 DMC

• 1 other identifier: ISCAP
• Study Type: interventional
• Target: 2,884
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 30-day MACEs after PCI

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

  30 days after PCI

Secondary Outcomes (5)

• Post-procedural change of inflammatory biomarkers (hs-CRP)

  24 hours after PCI

• Morbidity of CIN

  48 hours after PCI

• Elevation of ALT, AST and CK

  6 months after PCI

• Adverse events

  6 months after PCI

• Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events

  6 months after PCI

Study Arms (2)

Intensive statin therapy

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

Usual care

OTHER

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

Drug: Statin

Interventions

Atorvastatin DRUG

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

Also known as: Liptor

Intensive statin therapy

Statin DRUG

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

Also known as: Liptor, Zocor, Pravachol, Lescol

Usual care

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Division of Cardiology, Peking University First Hospital

Beijing, 10034, China

Location

MeSH Terms

Conditions

Angina, Unstable; Angina, Stable

Interventions

Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Pravastatin; Fluvastatin

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yong Huo, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of cardiology

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: June 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

CN (1)