<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02223143</url>
  </required_header>
  <id_info>
    <org_study_id>200910021R</org_study_id>
    <nct_id>NCT02223143</nct_id>
  </id_info>
  <brief_title>A Registration Study for Dyslipidemia</brief_title>
  <official_title>A Registration Study for Primary and Secondary Prevention in Dyslipidemic Taiwanese</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is a leading&#xD;
      cause of morbidity and mortality. Dyslipidemia has long been recognized to be the most&#xD;
      important risk factor in the development of atherosclerosis in human beings. In Taiwan, the&#xD;
      rates for hypercholesterolemia (≧250mg/dl) were 4.3% and 5.5% in 1970; 12.99% in 1980; and&#xD;
      17.1% in 1990. Those for hypertriglyceridemia (≧200 mg/dl) were 6.5% and 11.1% in 1970 and&#xD;
      13.0% in 1990. Low serum HDL-C was an isolated and independent coronary risk factor among a&#xD;
      good number of Taiwanese people. Lowering of low-density lipoprotein cholesterol (LDL-C) with&#xD;
      statins has in the last decade become part of the standard treatment regimen in patients with&#xD;
      dyslipidemia. However, most embarrassing, is the insufficient data for clinical use in&#xD;
      Taiwan. It is necessary to have rationalized and balanced guideline for the management of&#xD;
      dyslipidemia in Taiwan, based on our local epidemiological, clinical and basic research data.&#xD;
      Because all these trials were conducted in Caucasians and no large-scaled end-point research&#xD;
      about the lipid lowering therapy (LLT) was published in Asians before, this registry study&#xD;
      attempts to define the status of lipid lowering therapy in Taiwan and the effect of LLT on&#xD;
      CVD morbidity and mortality in a large population of patients receiving primary or secondary&#xD;
      prevention therapy. The medications will only depend on the decision made by the primary care&#xD;
      physicians. The patient or physician can decide to be withdrawn from this registry at any&#xD;
      time because of any reason. The lipid profile change, myopathy, or liver enzyme change after&#xD;
      the LLT will also be recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a registry study to define the status of lipid lowering therapy in Taiwan and the&#xD;
      effect of LLT on CVD morbidity and mortality in a large population of patients receiving&#xD;
      primary or secondary prevention therapy. The medications will only depend on the decision&#xD;
      made by the primary care physicians. The patient or physician can decide to be withdrawn from&#xD;
      this registry at any time because of any reason.&#xD;
&#xD;
      All potential patients will be screened for the eligibility in a screening visit. Those who&#xD;
      fill the inclusion criteria at screening will be invited for the registry study into&#xD;
      different groups. The follow-up will take place yearly thereafter for 5 years, through&#xD;
      clinical visiting, phone follow-up, or records from the NHIB Taiwan. At each clinical visit,&#xD;
      vital signs, clinical endpoints, adverse events, concurrent medication information and&#xD;
      laboratory specimens will be obtained as complete as possible. With phone or records from&#xD;
      NHIB, only clinical endpoints will be recorded. If the primary care physician intends to&#xD;
      treat the patient's lipid profile to the target, he/she can add, delete or adjust the LLT by&#xD;
      his/her clinical judgement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2009</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The time to first occurrence of a major cardiovascular event</measure>
    <time_frame>up to 5 years</time_frame>
    <description>The major CV (cardiovascular) event will be defined as CV death, hospitalization for nonfatal MI (myocardial infarction) or stroke, or cardiac arrest with resuscitation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite cardiovascular outcome</measure>
    <time_frame>up to 5 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The biochemistry change</measure>
    <time_frame>up to 5 years</time_frame>
    <description>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.</description>
  </other_outcome>
  <enrollment type="Anticipated">35000</enrollment>
  <condition>Atherosclerotic Vascular Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All potential patients will be screened for the eligibility in a screening visit. Those who&#xD;
        fill the inclusion criteria at screening will be invited for the registry study into&#xD;
        different groups.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One with atherosclerotic vascular diseases&#xD;
&#xD;
          -  One without ASVD but with at least 1 CV risk factor&#xD;
&#xD;
          -  Apparent healthy persons&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  One with hemodynamically significant valvular or congenital heart disease&#xD;
&#xD;
          -  One with any non-cardiovascular diseases which may affect prognosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>C C W</last_name>
    <role>Principal Investigator</role>
    <affiliation>chauchungwu@ntu.edu.tw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>C C W</last_name>
    <phone>+886-2-23123456</phone>
    <phone_ext>88560</phone_ext>
    <email>chauchungwu@ntu.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>W T K</last_name>
    <phone>+886-2-33668810</phone>
    <email>t87134@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NTUH</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>C C W</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>88560</phone_ext>
      <email>chauchungwu@ntu.edu.tw</email>
    </contact>
    <investigator>
      <last_name>W T K</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>November 14, 2016</last_update_submitted>
  <last_update_submitted_qc>November 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lipid lowering therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02223143
org study id: 200910021R
nct id: NCT02223143
lead sponsor: 
has dmc: Yes
Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is a leading
      cause of morbidity and mortality. Dyslipidemia has long been recognized to be the most
      important risk factor in the development of atherosclerosis in human beings. In Taiwan, the
      rates for hypercholesterolemia (≧250mg/dl) were 4.3% and 5.5% in 1970; 12.99% in 1980; and
      17.1% in 1990. Those for hypertriglyceridemia (≧200 mg/dl) were 6.5% and 11.1% in 1970 and
      13.0% in 1990. Low serum HDL-C was an isolated and independent coronary risk factor among a
      good number of Taiwanese people. Lowering of low-density lipoprotein cholesterol (LDL-C) with
      statins has in the last decade become part of the standard treatment regimen in patients with
      dyslipidemia. However, most embarrassing, is the insufficient data for clinical use in
      Taiwan. It is necessary to have rationalized and balanced guideline for the management of
      dyslipidemia in Taiwan, based on our local epidemiological, clinical and basic research data.
      Because all these trials were conducted in Caucasians and no large-scaled end-point research
      about the lipid lowering therapy (LLT) was published in Asians before, this registry study
      attempts 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. The lipid profile change, myopathy, or liver enzyme change after
      the LLT will also be recorded.
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.
observational model: Case-Only
time perspective: Prospective
measure: The time to first occurrence of a major cardiovascular event
time frame: up to 5 years
description: The major CV (cardiovascular) event will be defined as CV death, hospitalization for nonfatal MI (myocardial infarction) or stroke, or cardiac arrest with resuscitation
measure: Composite cardiovascular outcome
time frame: up to 5 years
description: 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.
measure: The biochemistry change
time frame: up to 5 years
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: C C W
role: Principal Investigator
affiliation: chauchungwu@ntu.edu.tw
last name: C C W
phone: +886-2-23123456
phone ext: 88560
email: chauchungwu@ntu.edu.tw
last name: W T K
phone: +886-2-33668810
email: t87134@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Atherosclerosis
sharing ipd: Yes