- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02223143
A Registration Study for Dyslipidemia
A Registration Study for Primary and Secondary Prevention in Dyslipidemic Taiwanese
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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 The patient or physician can decide to be withdrawn from this registry at any time because of any reason.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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Taipei, Taiwan
- Rekrytering
- NTUH
-
Kontakt:
- C C W
- Telefonnummer: 88560 886-2-23123456
- E-post: chauchungwu@ntu.edu.tw
-
Underutredare:
- W T K
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- One with atherosclerotic vascular diseases
- One without ASVD but with at least 1 CV risk factor
- Apparent healthy persons
Exclusion Criteria:
- One with hemodynamically significant valvular or congenital heart disease
- One with any non-cardiovascular diseases which may affect prognosis
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The time to first occurrence of a major cardiovascular event
Tidsram: 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
|
up to 5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Composite cardiovascular outcome
Tidsram: 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.
|
up to 5 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The biochemistry change
Tidsram: 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.
|
up to 5 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: C C W, chauchungwu@ntu.edu.tw
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 200910021R
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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