A Registration Study for Dyslipidemia
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|ClinicalTrials.gov Identifier: NCT02223143|
Recruitment Status : Recruiting
First Posted : August 22, 2014
Last Update Posted : November 15, 2016
|Condition or disease|
|Atherosclerotic Vascular Diseases|
This is a registry study to define the status of lipid lowering therapy in Taiwan and the effect of LLT on CVD morbidity and mortality in a large population of patients receiving primary or secondary prevention therapy. The medications will only depend on the decision made by the primary care physicians. The patient or physician can decide to be withdrawn from this registry at any time because of any reason.
All potential patients will be screened for the eligibility in a screening visit. Those who fill the inclusion criteria at screening will be invited for the registry study into different groups. The follow-up will take place yearly thereafter for 5 years, through clinical visiting, phone follow-up, or records from the NHIB Taiwan. At each clinical visit, vital signs, clinical endpoints, adverse events, concurrent medication information and laboratory specimens will be obtained as complete as possible. With phone or records from NHIB, only clinical endpoints will be recorded. If the primary care physician intends to treat the patient's lipid profile to the target, he/she can add, delete or adjust the LLT by his/her clinical judgement.
|Study Type :||Observational|
|Estimated Enrollment :||35000 participants|
|Official Title:||A Registration Study for Primary and Secondary Prevention in Dyslipidemic Taiwanese|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||October 2017|
- The time to first occurrence of a major cardiovascular event [ Time Frame: up to 5 years ]The major CV (cardiovascular) event will be defined as CV death, hospitalization for nonfatal MI (myocardial infarction) or stroke, or cardiac arrest with resuscitation
- Composite cardiovascular outcome [ Time Frame: up to 5 years ]The composite cardiovascular (CV) outcome will be any CV events (any major CV events plus hospitalization for any revascularization procedure, unstable angina, or congestive heart failure, and peripheral arterial disease, defined as new clinical diagnosis or hospitalization for such disease). In addition, individual components of the composite end points will be also prespecified as secondary outcomes, as will all-cause mortality.
- The biochemistry change [ Time Frame: up to 5 years ]The tertiary objective of this trial is to evaluate the biochemistry change of lipid profile change, myopathy, or liver enzyme change after the lipid lowering therapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223143
|Contact: C C W||+886-2-23123456 ext email@example.com|
|Contact: W T Kfirstname.lastname@example.org|
|Contact: C C W 886-2-23123456 ext 88560 email@example.com|
|Sub-Investigator: W T K|
|Principal Investigator:||C C Wfirstname.lastname@example.org|