Rosuvastatin Evaluation of Atherosclerotic Chinese Patients (REACH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis

NCT02546323

Atherosclerosis

COMPLETED PHASE3

A High-Resolution Magnetic Resonance Imaging Study to Evaluate the Effect of Rosuvastatin on Carotid Atherosclerotic Plaques

NCT02305862

Arteriosclerosis Diabetes Mellitus Lipid Disorder

UNKNOWN NA

LDL-C Lowering Efficacy and Safety of Rosuvastatin 20 mg/Day to10 mg/Day in Chinese ACS(Acute Coronary Syndrome) Patients

NCT02077257

Acute Coronary Syndrome

UNKNOWN PHASE4

A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques

NCT02532309

Carotid Atherosclerosis

UNKNOWN PHASE4

Resuvastatin Treatment for Symptomatic Middle Cerebral Artery Stenosis Based on High-resolution Magnetic Resonance Imaging

NCT02041117

Intracranial Arterial Stenosis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of 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

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlipidemia Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treat

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.

Group Type EXPERIMENTAL

Rosuvastatin (Crestor)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rosuvastatin (Crestor)

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Crestor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female patients between 18 and 75 years of age, inclusive.
2. LDL-C concentration ≥ 100mg/dl (2.6mmol/L), but less than 250mg/dl (6.5mmol/L); and TG ≤ 353mg/dl (4.0mmol/L).
3. New patients in regard to statin therapy.
4. 16%-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).
5. 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.
6. 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.
7. The patient must be able to comply with scheduled visits, the treatment plan and all laboratory tests.
8. The patient must provide written voluntary informed consent to participate in the study.

Exclusion Criteria

1. 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.
2. 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.
3. The patient has plans for surgical/endovascular intervention for carotid, coronary and/or peripheral arterial disease during the course of the study.
4. The patient has critical limb ischemia, as evidenced by ischemic rest pain, ulceration, or gangrene.
5. 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.
6. The patient has a history of malignant neoplasm within the previous 5 years (exception: curable non-melanoma skin malignancies).
7. The patient has a known immunodeficient state (e.g., human immunodeficiency virus) or is being treated with immunosuppressive drugs including cyclosporine.
8. The patient have to take medicines as follow:

* Hormonal therapy
* Cyclosporine
* Other lipid lowering agents: fish oil, garlic essential oil etc.
9. The patient has suffered deep vein thrombosis within the previous 3 months.
10. The patient has suffered brain haemorrhage before the study.
11. The patient has a history of recent alcohol abuse, drug abuse or significant mental illness.
12. The patient has any condition that would prevent the patient from giving voluntary informed consent.
13. The patient has an inability to tolerate oral medication administration.
14. The patient has a known or suspected allergy to the study medication(s) or the class of study medication to be administered.
15. The patient has a known or suspected allergy to MRI contrast agents (e.g., gadolinium).
16. The patient is enrolled or plans to enroll in another clinical drug or device/interventional trial during this study.
17. The patient has any other clinically significant medical condition that, in the opinion of the Investigator, could impact the patient's ability to successfully complete the trial.
18. The patient has the history of myopathy.
19. The patient has the history of epilepsy/seizures.
20. The patient has thyroid stimulating hormone (TSH) \> 1.5xULN.
21. The patients has LDL cholesterol \> 250mg/dL or total cholesterol \> 309 mg/dL or familial hypercholesterolemia.
22. The patient has uncontrolled hypertension, with SBP \>160 mmHg and / or DBP \>100 mmHg.
23. The patient has uncontrolled hyperglycemia with HbA1c \> 9% or diagnosed as DM recently (within 1 month before enrolment)
24. BMI ≥ 30 kg/m2
25. The patient has a pacemaker or other metallic foreign body.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No