Ezetimibe and Atorvastatin Therapy on TCFA

NCT02588235 | Unknown Phase 4 DMC

• 1 other identifier: TCFA-OCT XIJING01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• minimum fibrous cap thickness

  The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.

  12months

Study Arms (2)

Ezetimibe and Atorvastatin Therapy

EXPERIMENTAL

Atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）

Drug: Ezetimibe and Atorvastatin

Atorvastatin Therapy

ACTIVE COMPARATOR

Atorvastatin (20 mg/day）

Drug: Atorvastatin

Interventions

Ezetimibe and Atorvastatin DRUG

atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）

Also known as: Ezetrol and lipitor

Ezetimibe and Atorvastatin Therapy

Atorvastatin DRUG

atorvastatin (20 mg/day）

Also known as: Lipitor

Atorvastatin Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable angina or acute coronary syndrome 2.18-80 years old 3.hypercholesterolemia :total cholesterol level \>220 mg/dl (5.7mmol/L) and/or LDL-C level \>140 mg/dl(3.6mmol/L), or previously receiving statins therapy 4. the target vessel for OCT interrogation has not undergone angioplasty and has angiographic diameter stenosis from 25% to 75% 5.There are TCFAs in non-culprit, mild-to-moderate stenotic lesions above

You may not qualify if:

• administration of lipid-lowering drugs other than statins before enrollment
• significant stenotic lesions in all coronary vessels
• severe congestive heart failure (New York Heart Association class IV) ,or left ventricular ejection fraction\<35%
• more than 3 times of the upper limit of normal (ULN) in the creatine kinase (CK) and the transaminase level before enrollment and no relation with myocardial infarction
• renal failure (serum creatinine\>2.0 mg/dL）
• hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe
• Others: terminal stage cancer,a positive pregnancy test

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ezetimibe; Atorvastatin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yan Li, M.D., Ph.D.

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongdong Sun, M.D., Ph.D.

CONTACT

86 29 84775183; 51483696@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

CN (1)