Rapid Escalation of LipiD Lowering Therapy to Reduce RecUrrent Cardiovascular Event
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
Hyperlipidaemia especially elevation of low-density lipoprotein cholesterol (LDL-C) is known to be the main contributor to the development of atherosclerotic cardiovascular disease (ASCVD).
Lowering LDL-C have been shown to reduce the risk of ASCVD2,3. Both the American Heart Association (AHA) and the European Society of Cardiology (ESC) advocated aggressive LDL-C target with statin being the first-line lipid-lowering therapy (LLT). However, a significant portion of patients did not attain their LDL-C goal in our locality. Statin no adherence, low uptake of adjuvant non-statin LLT, and therapeutic inertia are few potential causes for not achieving the LDL-C target. ESC recommends repeating blood test in 6-8 weeks after addition or alternation of LLT, but this recommendation was not routinely followed in current local practice due to resources constrain.
This registry therefore aims to investigate the strategy of frequent monitoring of LDL-C and titration of LLT in achieving LDL-C treatment target at a dedicated specialist clinic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18
(Cohort 1) Diagnosis of acute coronary syndrome due to atherosclerotic coronary artery disease
(Cohort 2) Diagnosis of chronic coronary syndrome due to atherosclerotic coronary artery disease
Disqualifiers
Inability to provide valid consent by the patient or his legal guardian
Diagnosis of ACS due to other causes than atherosclerotic coronary artery disease.
Psychiatric or severe neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months.
Trial population
Patients aged greater than 18 and who are admitted for a diagnosis of acute coronary syndrome (ACS) due to atherosclerotic coronary artery disease based on invasive coronary angiography will be recruited into this registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Acute Coronary Syndrome
Group B: Chronic coronary syndrome
Trial outcomes
Primary outcomes
1
Low-density lipoprotein cholesterol (LDL-C) level
Absolute change in low-density lipoprotein cholesterol (LDL-C) level at baseline
Time frame
Baseline2
Low-density lipoprotein cholesterol (LDL-C) level
Absolute change in low-density lipoprotein cholesterol (LDL-C) level at week 8
Time frame
week 83
Low-density lipoprotein cholesterol (LDL-C) level
Absolute change in low-density lipoprotein cholesterol (LDL-C) level at week 26
Time frame
Week 264
Low-density lipoprotein cholesterol (LDL-C) level
Absolute change in low-density lipoprotein cholesterol (LDL-C) level at week 52
Time frame
Week 52Secondary outcomes
1
Rate of subject meeting LDL-C target
Proportion of patients meeting prespecified LDL-C goals (\>50% reduction from baseline) at week 26.
Time frame
Week 262
Rate of subject meeting LDL-C target
Proportion of patients meeting prespecified LDL-C goals (\<1.4mmol/l) at week 26.
Time frame
Week 263
Rate of subject meeting LDL-C target
Proportion of patients meeting prespecified LDL-C goals (\<1.8mmol/L) at week 26.
Time frame
Week 264
12-Item Short Form Survey (SF-12)
Patient's quality of life as measured by SF-12 at baseline
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov