Rosuvastatin Evaluation of Atherosclerotic Chinese Patients (REACH)

NCT00885872 | Unknown Phase 4

• 2 other identifiers: REACHD3560L00091
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the effect of rosuvastatin 10-20 mg on carotid atherosclerosis progression in Chinese patients by evaluating the change in the percentage of volume of lipid rich necrotic core (LRNC) using high-resolution magnetic resonance imaging (MRI) after 24-months treatment.

Conditions

Hyperlipidemia; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Change in the percentage of volume of lipid rich necrotic core (LRNC)using high-resolution MRI

  Disease progresson will be determined by the change in the percentage of volume of LRNC measured at 104 weeks (+/-14days) following the initiation of drug treatment in patients with atherosclerotic disease from baseline

  2 years

Secondary Outcomes (1)

• change in volume of wall and normalized wall index (NWI)

  2 years

Study Arms (1)

Treat

EXPERIMENTAL

At visit 2 each eligible subject will be allocated to rosuvastatin. Subjects who reach the criteria at visit 3, dosage of rosuvastatin will be titrated. The subjects will be encouraged to take the study drug at the same time each day for 104 weeks.

Drug: Rosuvastatin (Crestor)

Interventions

Rosuvastatin (Crestor) DRUG

at visit 2 each eligible subject will be allocated to rosuvastatin. study medication wil be taken orally with water once daily, as directed by the study physician. subjects who meet the criteria at visit 3, dosage of rosuvastatin will be titrated.

Also known as: Crestor

Treat

Eligibility Criteria

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

You may qualify if:

• Male or female patients between 18 and 75 years of age, inclusive.
• LDL-C concentration ≥ 100mg/dl (2.6mmol/L), but less than 250mg/dl (6.5mmol/L); and TG ≤ 353mg/dl (4.0mmol/L).
• New patients in regard to statin therapy.
• %-69% carotid artery stenosis by duplex ultrasound. At least one or more carotid plaques detectable in either the right or left side of the carotid artery 2.4 cm proximal and 2.4 cm distal to the bifurcation. Plaque must be more than 3 mm thick with calcification presenting less than 50% of the plaque area. The plaque must have a LRNC and intact fibrous cap detected by contrast-enhanced MRI (CE MRI).
• Female patients must agree to use an effective form of birth control throughout the 2-year study treatment period. They must be either documented post-menopausal, physically or surgically incapable of bearing children, or using barrier contraceptive methods. In addition to using contraception, women of childbearing potential must also have a negative serum pregnancy test at Screening.
• The patients who are willing to be enrolled have to remain on the low cholesterol dietary (refer to Chinese Guideline on Treatment of Dyslipidemia in Adult) for the study duration.
• The patient must be able to comply with scheduled visits, the treatment plan and all laboratory tests.
• The patient must provide written voluntary informed consent to participate in the study.

You may not qualify if:

• The patient has liver function tests \> 1.5 times the upper limit of normal, serum creatinine \> 2.0 mg/dL, GFR \< 30 ml/min or has abnormal laboratory values which are deemed clinically significant by the investigator.
• The patient has severe heart disease, including NYHA III-IV, uncontrolled arrhythmia and acute coronary syndrome. The patient has had a coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), carotid endarterectomy (CEA), carotid artery stent, or lower extremity revascularization/amputation. The patient had unstable angina or myocardial infarct within 3 months before enrolment.
• The patient has plans for surgical/endovascular intervention for carotid, coronary and/or peripheral arterial disease during the course of the study.
• The patient has critical limb ischemia, as evidenced by ischemic rest pain, ulceration, or gangrene.
• The patient has or is being treated or evaluated for diagnosed tuberculosis. The patient has had a chest x-ray obtained within the last month which shows signs consistent with possible tuberculosis.
• The patient has a history of malignant neoplasm within the previous 5 years (exception: curable non-melanoma skin malignancies).
• The patient has a known immunodeficient state (e.g., human immunodeficiency virus) or is being treated with immunosuppressive drugs including cyclosporine.
• The patient have to take medicines as follow:
• Hormonal therapy
• Cyclosporine
• Other lipid lowering agents: fish oil, garlic essential oil etc.
• The patient has suffered deep vein thrombosis within the previous 3 months.
• The patient has suffered brain haemorrhage before the study.
• The patient has a history of recent alcohol abuse, drug abuse or significant mental illness.
• The patient has any condition that would prevent the patient from giving voluntary informed consent.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (1)

• Du R, Cai J, Zhao XQ, Wang QJ, Liu DQ, Leng WX, Gao P, Wu HM, Ma L, Ye P. Early decrease in carotid plaque lipid content as assessed by magnetic resonance imaging during treatment of rosuvastatin. BMC Cardiovasc Disord. 2014 Jul 14;14:83. doi: 10.1186/1471-2261-14-83.

  PMID: 25022285 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Atherosclerosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ping Ye, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Du Ruixue, Dr/

CONTACT

13693578338; drx1972@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 27, 2010

Record last verified: 2009-04

Locations

CN (1)