Rosuvastatin Evaluation of Atherosclerotic Chinese Patients (REACH) (REACH)
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|ClinicalTrials.gov Identifier: NCT00885872|
Recruitment Status : Unknown
Verified April 2009 by Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : April 22, 2009
Last Update Posted : May 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipidemia Atherosclerosis||Drug: Rosuvastatin (Crestor)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 104-week, Open-label, Single-group Study: Rosuvastatin Evaluation of Atherosclerotic Chinese Patients (REACH)|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||March 2012|
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)
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.
Other Name: Crestor
- Change in the percentage of volume of lipid rich necrotic core (LRNC)using high-resolution MRI [ Time Frame: 2 years ]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
- change in volume of wall and normalized wall index (NWI) [ Time Frame: 2 years ]change in volume of wall and NWI measured at 13 weeks (+/-7days), 52 weeks (+/-7days), and 104 weeks (+/- 7days) following the initiation of drug treatment in patients with atherosclerotic disease from baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885872
|Contact: Du Ruixue, Drfirstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100000|
|Contact: Du Ruixue, Dr. 13693578338 email@example.com|
|Principal Investigator:||Ping Ye, Doctor||Chinese PLA General Hospital|