- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07311941
Rapid Escalation of LipiD Lowering Therapy to Reduce RecUrrent Cardiovascular Event (REDUCE-Lipid)
Rapid Escalation of LipiD Lowering Therapy to Reduce RecUrrent Cardiovascular Event (REDUCE) : All Comers Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Guangming Tan
- Phone Number: 852-35051518
- Email: xjldaniel@gmail.com
Study Locations
-
-
New Terrritories
-
Shatin, New Terrritories, Hong Kong, 999077
- Recruiting
- Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Acute Coronary Syndrome
Patient with acute coronary syndrome due to atherosclerotic coronary artery disease
|
|
Chronic coronary syndrome
Patient with chronic coronary syndrome due to atherosclerotic coronary artery disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Low-density lipoprotein cholesterol (LDL-C) level
Time Frame: Baseline
|
Absolute change in low-density lipoprotein cholesterol (LDL-C) level at baseline
|
Baseline
|
|
Low-density lipoprotein cholesterol (LDL-C) level
Time Frame: week 8
|
Absolute change in low-density lipoprotein cholesterol (LDL-C) level at week 8
|
week 8
|
|
Low-density lipoprotein cholesterol (LDL-C) level
Time Frame: Week 26
|
Absolute change in low-density lipoprotein cholesterol (LDL-C) level at week 26
|
Week 26
|
|
Low-density lipoprotein cholesterol (LDL-C) level
Time Frame: Week 52
|
Absolute change in low-density lipoprotein cholesterol (LDL-C) level at week 52
|
Week 52
|
|
Low-density lipoprotein cholesterol (LDL-C) level
Time Frame: Baseline
|
Percentage change in low-density lipoprotein cholesterol (LDL-C) level at Baseline
|
Baseline
|
|
Low-density lipoprotein cholesterol (LDL-C) level
Time Frame: Week 8
|
Percentage change in low-density lipoprotein cholesterol (LDL-C) level at week 8
|
Week 8
|
|
Low-density lipoprotein cholesterol (LDL-C) level
Time Frame: Week 26
|
Percentage change in low-density lipoprotein cholesterol (LDL-C) level at week 26
|
Week 26
|
|
Low-density lipoprotein cholesterol (LDL-C) level
Time Frame: Week 52
|
Percentage change in low-density lipoprotein cholesterol (LDL-C) level at week 52
|
Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of subject meeting LDL-C target
Time Frame: Week 26
|
Proportion of patients meeting prespecified LDL-C goals (>50% reduction from baseline) at week 26.
|
Week 26
|
|
Rate of subject meeting LDL-C target
Time Frame: Week 26
|
Proportion of patients meeting prespecified LDL-C goals (<1.4mmol/l) at week 26.
|
Week 26
|
|
Rate of subject meeting LDL-C target
Time Frame: Week 26
|
Proportion of patients meeting prespecified LDL-C goals (<1.8mmol/L) at week 26.
|
Week 26
|
|
12-Item Short Form Survey (SF-12)
Time Frame: Baseline
|
Patient's quality of life as measured by SF-12 at baseline
|
Baseline
|
|
12-Item Short Form Survey (SF-12)
Time Frame: Week 8
|
Patient's quality of life as measured by SF-12 at week 8
|
Week 8
|
|
12-Item Short Form Survey (SF-12)
Time Frame: Week 26
|
Patient's quality of life as measured by SF-12 at week 26
|
Week 26
|
|
12-Item Short Form Survey (SF-12)
Time Frame: Week 52
|
Patient's quality of life as measured by SF-12 at week 52
|
Week 52
|
|
Rate of major adverse cardiovascular event (MACE)
Time Frame: Baseline
|
Occurrence of any major adverse cardiovascular event (MACE) at Baseline
|
Baseline
|
|
Rate of major adverse cardiovascular event (MACE)
Time Frame: Week 8
|
Occurrence of any major adverse cardiovascular event (MACE) at week 8
|
Week 8
|
|
Rate of major adverse cardiovascular event (MACE)
Time Frame: Week 26
|
Occurrence of any major adverse cardiovascular event (MACE) at week 26
|
Week 26
|
|
Rate of major adverse cardiovascular event (MACE)
Time Frame: Week52
|
Occurrence of any major adverse cardiovascular event (MACE) at week 52
|
Week52
|
|
Modification of lipid lowering therapy (LLT)
Time Frame: Week 8
|
Modification of lipid lowering therapy (LLT) at week 8
|
Week 8
|
|
Modification of lipid lowering therapy (LLT)
Time Frame: Week 26
|
Modification of lipid lowering therapy (LLT) at week 26
|
Week 26
|
|
Modification of lipid lowering therapy (LLT)
Time Frame: Week 52
|
Modification of lipid lowering therapy (LLT) at week 52
|
Week 52
|
|
Lipid Lowering Therapy adherence
Time Frame: Week 52
|
LLT adherence, expressed in proportion of days covered, at week 52
|
Week 52
|
|
Tolerability of Lipid Lowering Therapy
Time Frame: Week 52
|
Rate of adverse drug event reported by subjects on lipid lowering therapy at week 52
|
Week 52
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024.356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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