Virtual Histology Findings and Effects of Varying Doses of Atorvastatin Treatment

NCT01200056 | Completed Phase 4 DMC

• 2 other identifiers: UW 07-266 (IRB HKU)HKCTR-517
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

While statin treatment may induce plaque regression, the effect of statin on plaque composition with varying doses is unknown. This study assessed such effects by volumetric virtual histology intravascular ultrasound (VH-IVUS). In this prospective, randomized, double-blinded pilot study, statin-naïve patients with stable angina requiring percutaneous coronary intervention (PCI) were randomized to receive 6 months of either atorvastatin 10mg or 40 mg daily. VH-IVUS was performed in all non-PCI lesions at baseline and 6 months; all analyses were performed by core laboratory.

Conditions

Coronary Disease; Ultrasonography, Interventional; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Keywords

Volumetric virtual histology intravascular ultrasound.; Statin-naive patient.; Varying doses atorvastatin.; Clinical outcomes.

Outcome Measures

Primary Outcomes (1)

• The primary endpoint would be the 6-month angiographic and VH-IVUS restudy findings.

  Our hypothesis was plaque regression and virtual histology intravascular ultrasound (VH-IVUS) plaque modification with statin therapy could be statin dose dependent, and may affect clinical outcomes. 2 clinically realistic doses of atorvastatin 10mg and 40mg were chosen in statin-naïve patients without previous myocardial infarction. The primary endpoint of this study would therefore be the 6 months angiographic and IVUS follow-up, looking at the volumetric gray-scale IVUS and VH-IVUS findings at 6 months for the whole cohort as well as the differences between the 2 groups.

  6 months

Secondary Outcomes (1)

• The secondary endpoint would be the occurrence of any major adverse cardiac events at 6 months (including any death, myocardial infarction or need for revascularization) as routinely monitored after all percutaneous interventional procedures.

  Throughout the 6 months study period.

Study Arms (2)

Atorvastatin 10mg low dose

ACTIVE COMPARATOR

Atorvastatin 10mg daily for 6 months and compared to atorvastatin 40mg daily in the other arm. The primary endpoint of 6 months VH-IVUS findings and clinical outcomes would be monitored and compared.

Drug: Atorvastatin 10mg versus 40mg.

Atorvastatin 40mg moderate dose

ACTIVE COMPARATOR

Atorvastatin 40mg daily for 6 months and compared to atorvastatin 10mg daily in the other arm. The primary endpoint of 6 months VH-IVUS findings and clinical outcomes would be monitored and compared.

Drug: Atorvastatin 10mg versus 40mg.

Interventions

Atorvastatin 10mg versus 40mg. DRUG

2 arms comparing atorvastatin 10mg daily for 6 months to atorvastatin 40mg daily for 6 months. The primary endpoint would be the 6 months VH-IVUS findings and clinical outcomes.

Also known as: Lipitor 10mg versus 40mg daily for 6 months.

Atorvastatin 10mg low dose; Atorvastatin 40mg moderate dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 to 85 (not pregnant) requiring percutaneous intervention to coronary stenosis.
• Statin naive patient.
• No history of myocardial infarction. Angina free for at least 8 weeks.

You may not qualify if:

• Any history of previous statin treatment and myocardial infarction
• Current acute coronary syndrome or in cardiogenic shock
• Surgical bypass candidate
• Chronic total occlusion and very tortuous calcified arteries precluding safe IVUS examination.
• Patient refused to give written informed consent.

Sponsors & Collaborators

• Prof. Stephen Lee: lead
• Queen Mary Hospital, Hong Kong: collaborator
• Pfizer: collaborator

Study Sites (1)

Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority

Hong Kong SAR, Hong Kong, China

Location

Related Publications (31)

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MeSH Terms

Conditions

Coronary Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Prof. Stephen WL LEE, MD FRCP FACC

  Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: August 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: June 1, 2010
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

CN (1)