Yokohama Assessment of Fluvastatin, Pravastatin, Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Yokohama-ACS)

NCT00549926 | Completed Phase 4

• 1 other identifier: Yokohama-ACS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of fluvastatin, pravastatin, pitavastatin, and atorvastatin on coronary plaque volume in patients with acute coronary syndrome, and to clarify the impact of moderate and intensive lipid lowering therapy on coronary plaque volume, serum lipids, and inflammation markers in patients with acute coronary syndrome in Japanese.

Conditions

Coronary Disease; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• the percent change in coronary plaque volume the percent change in integrated backscatter signal obtained by integrated backscatter IVUS

  9-11 month

Secondary Outcomes (3)

• absolute change from baseline in coronary plaque volume

  9-11 month

• absolute and percent changes in minimal lumen diameter(MLD) and percent(%) stenosis

  9-11 month

• absolute and percent changes in total cholesterol(TC);low-density lipoprotein(LDL)-cholesterol(LDL-C)

  9-11 month

Study Arms (4)

1

ACTIVE COMPARATOR

Drug: Fluvastatin

2

ACTIVE COMPARATOR

Drug: Pravastatin

3

ACTIVE COMPARATOR

Drug: Pitavastatin

4

ACTIVE COMPARATOR

Drug: Atorvastatin

Interventions

Fluvastatin DRUG

1

Pravastatin DRUG

2

Pitavastatin DRUG

3

Atorvastatin DRUG

4

Eligibility Criteria

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

You may qualify if:

• Patients who have been diagnosed as acute coronary syndrome, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) guidance.
• Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery.
• Patients with hypercholesterolemia as defined by any of the following criteria:
• TC ≧ 220 mg/dL
• LDL-C ≧ 140 mg/dL Cholesterol-lowering treatment is allowed according to the investigator's judgement when LDL-C ≧ 100 mg/dL or TC ≧ 180 mg/dL.
• Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial.
• Patients 20 years or older at the time of their consent.

You may not qualify if:

• Patients with bypass graft or in-stent restenosis at the site of PCI.
• Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.
• Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.
• Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors).
• Patients with familial hypercholesterolemia.
• Patients with cardiogenic shock.
• Patients receiving cyclosporine.
• Patients with any allergy to pravastatin, fluvastatin, pitavastatin, or atorvastatin.
• Patients with hepatobiliary disorders.
• Pregnant women, women suspected of being pregnant, or lactating women.
• Patients with renal disorders or undergoing dialysis.
• Patients who are ineligible in the opinion of the investigator.

Sponsors & Collaborators

• Yokohama City University Medical Center: lead

Study Sites (1)

Yokohama City University Medical Center

Yokohama, Japan

Location

Related Publications (2)

• Matsushita K, Hibi K, Komura N, Kimura Y, Matsuzawa Y, Konishi M, Maejima N, Iwahashi N, Kosuge M, Ebina T, Tamura K, Kimura K. Impact of serum lipoprotein (a) level on coronary plaque progression and cardiovascular events in statin-treated patients with acute coronary syndrome: a yokohama-acs substudy. J Cardiol. 2020 Jul;76(1):66-72. doi: 10.1016/j.jjcc.2020.01.005. Epub 2020 Feb 7.

  PMID: 32037254 DERIVED

• Hibi K, Sonoda S, Kawasaki M, Otsuji Y, Murohara T, Ishii H, Sato K, Koshida R, Ozaki Y, Sata M, Morino Y, Miyamoto T, Amano T, Morita S, Kozuma K, Kimura K, Fujiwara H; Ezetimibe-ACS Investigators. Effects of Ezetimibe-Statin Combination Therapy on Coronary Atherosclerosis in Acute Coronary Syndrome. Circ J. 2018 Feb 23;82(3):757-766. doi: 10.1253/circj.CJ-17-0598. Epub 2017 Dec 7.

  PMID: 29212965 DERIVED

MeSH Terms

Conditions

Coronary Disease; Hypercholesterolemia

Interventions

Fluvastatin; Pravastatin; pitavastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Naohiro Komura

  Yokohama City University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 26, 2007
• Study Start: October 1, 2007
• Study Completion: February 1, 2010
• Last Updated: February 17, 2010

Record last verified: 2010-02

Locations

JP (1)