Chronic Coronary SyndromeREC-SAFETARGETNCT06821711
Optimal LDL-C Target in High-risk Patients After PCI
A study of Chronic Coronary Syndrome and Acute Coronary Syndromes, run by Xijing Hospital at 1 site in China.
Trial summary
Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD), establishing LDL-C as both a pathogenic risk factor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome, Acute Coronary Syndromes, Percutaneous Coronary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2025to 15 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients underwent percutaneous coronary intervention due to acute or chronic coronary syndrome
- Patients with ASCVD at extremely high risk
- Patients who are able to complete the follow-up and compliant with the allocated treatment
- ASCVD at extremely high risk is defined as fulfilling at least TWO of the following criteria:
- PCI for acute myocardial infarction (AMI, including STEMI or NSTEMI)
- Previous AMI, previous stroke, or previous intervention or surgery for peripheral vascular disease
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- Experienced cardiovascular event(s) with LDL-C≤1.8mmol/L
- LDL-C≥4.9mmol/L
- Diabetes
- CKD (eGFR < 60 ml/min/1.73m2)
- Current smoking
- Recurrent cardio/cerebrovascular events
- History of premature ASCVD (< 55 male, < 65 female)
- Complex PCI (fulfilling at least one of the following criteria: multivessel disease; in-stent restenosis; ≥ 3 stents implanted; total stent length ≥ 60 mm; bifurcation; left main disease; target lesions allocated in bypass graft; chronic total occlusion (≥ 3 months of occlusion))
Who cannot join
- Age less than 18 years;
- Unable to give informed consent or currently participating in other trials;
- Patient who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to randomization in women of child-bearing potential according to local practice), or plans to become pregnant during treatment;
- Concurrent medical condition with a life expectancy of less than 3 years;
- Hemodynamic unstable;
- Active liver disease or hepatic dysfunction (persistent unexplained ALT/AST elevations (≥ 3 × ULN)), patients with a transient increase ALT/AST due to the acute MI may be enrolled;
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- Unable to reach the LDL-C target by known intolerance or contradiction of lipid control medications;
- LDL-C ≤ 1.4 mmol/L at baseline without any lipid control medication lowering LDL-C;
- Known active infection or critical hematologic/endocrine dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Targeting LDL-C to Less Than 0.8 mmol/L in Patients After PCI With High Risk of Cardiovascular Disease: an Open-label, Assessor-blinded, Randomized Trial (REC-SAFETARGET Trial)
Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD), establishing LDL-C as both a pathogenic risk factor and a critical therapeutic target.
Lipid-lowering therapies targeting LDL-C have significantly decreased the overall risk in ASCVD patients. Consequently, current guidelines recommend, based on risk stratification, lowering LDL-C levels in high-risk ASCVD patients to <1.4 mmol/L with a ≥50% reduction from baseline. Findings from PROVE IT-TIMI 22, IMPROVE-IT, ODYSSEY OUTCOMES, and FOURIER-OLE trials suggest that achieving extremely low LDL-C levels may further reduce the risk of cardiovascular events in ASCVD patients without substantially increasing clinically relevant adverse events; however, randomized data was still scarce in supporting this notion.
Against these backgrounds, we have designed this trial to investigate whether targeting LDL-C levels <0.8 mmol/L in high-risk ASCVD patients results in a significant reduction in adverse events compared to targeting LDL-C levels of 0.8-1.4 mmol/L.
- Conditions
- Chronic Coronary Syndrome, Acute Coronary Syndromes, Percutaneous Coronary Intervention, High Risk Patient
- Being tested
- Intensive LDL-C control, Conventional LDL-C control
- Keywords
- Acute coronary syndrome, Chronic coronary syndrome, Percutaneous coronary intervention, LDL-C, lipid
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive LDL-C controlOther
By Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up;
For patients with baseline LDL-C level < 3.0 mmol/L, it is recommended to start lipid control by statin + PCSK9i; for LDL-C level ≥ 3.0 mmol/L, statin + ezetimibe + PCSK9i
Conventional LDL-C controlOther
By Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up;
For patients with baseline LDL-C level < 3.0 mmol/L, it is recommended to start lipid control by statin alone or statin + ezetimibe; for LDL-C level ≥ 3.0 mmol/L, statin + PCSK9i
| Study group | Role | What they receive |
|---|---|---|
| LDL-C target < 0.8 mmol/L | Experimental | After randomization, investigators will optimize the intensive lipid-lowering regimen based on the patient's prior medication history, baseline LDL-C level, and target LDL-C level, adjusting and titrating LDL-C levels to achieve the target range. Receives: Other: Intensive LDL-C control |
| LDL-C target of 0.8 to 1.4 mmol/L | Active comparator | After randomization, investigators will optimize the intensive lipid-lowering regimen based on the patient's prior medication history, baseline LDL-C level, and target LDL-C level, adjusting and titrating LDL-C levels to achieve the target range. Receives: Other: Conventional LDL-C control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular and Cerebrovascular Events
MACCE, a composite of cardiovascular death, stroke, myocardial infarction, and any revascularization.
Measured: 24 months
Secondary outcomes (13)
Patient-oriented composite endpoint
PoCE, a composite of all-cause death, stroke, myocardial infarction, revascularization, is the first major secondary outcome.
Measured: 24 months
Device-oriented Composite Endpoint
DoCE, a composite of cardiovascular death, target vessel myocardial infarction, clinically and physiologically-indicated target lesion revascularization, is the second major secondary outcome.
Measured: 24 months
Composite of all-cause death, stroke, and myocardial infarction
The composite of all-cause death, stroke, and myocardial infarction is the third major secondary outcome.
Measured: 24 months
All-cause death
All-cause death is considered as other secondary endpoint
Measured: 24 months
Cardiovascular death
Cardiovascular death is considered as other secondary endpoint
Measured: 24 months
Myocardial infarction
Myocardial infarction is considered as other secondary endpoint
Measured: 24 months
Stroke
Stroke is considered as other secondary endpoint
Measured: 24 months
Ischemic stroke
Ischemic stroke is considered as other secondary endpoint
Measured: 24 months
Hemorrhagic stroke
Hemorrhagic stroke is considered as other secondary endpoint
Measured: 24 months
Revascularization
Revascularization is considered as other secondary endpoint
Measured: 24 months
Target lesion revascularization
Target lesion revascularization is considered as other secondary endpoint
Measured: 24 months
Clinically and physiologically-indicated target lesion revascularization
Clinically and physiologically-indicated target lesion revascularization is considered as other secondary endpoint
Measured: 24 months
Cardiovascular hospitalization
Cardiovascular hospitalization is considered as other secondary endpoint
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion15 Aug 2029 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Tao, MD, PhD, Xijing Hospital
- Investigators
- Ling Tao, Ph.D., M.D., Study chair, Department of Cardiology, Xijing HospitalChao Gao, Ph.D., M.D., Study chair, Department of Cardiology, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821711
- Sponsor's protocol ID
- KY20242295-F-1
- Acronym
- REC-SAFETARGET
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting LDL-C to Less Than 0.8 mmol/L in Patients After PCI With High Risk of Cardiovascular Disease: an Open-label, Assessor-blinded, Randomized Trial (REC-SAFETARGET Trial)
- ClinicalTrials.gov ID
- NCT06821711
- Acronym / sponsor ID
- REC-SAFETARGET / KY20242295-F-1
- Conditions
- Chronic Coronary Syndrome, Acute Coronary Syndromes, Percutaneous Coronary Intervention, High Risk Patient
- Keywords
- Acute coronary syndrome, Chronic coronary syndrome, Percutaneous coronary intervention, LDL-C, lipid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD), establishing LDL-C as both a pathogenic risk factor and a critical therapeutic target.
Lipid-lowering therapies targeting LDL-C have significantly decreased the overall risk in ASCVD patients. Consequently, current guidelines recommend, based on risk stratification, lowering LDL-C levels in high-risk ASCVD patients to <1.4 mmol/L with a ≥50% reduction from baseline. Findings from PROVE IT-TIMI 22, IMPROVE-IT, ODYSSEY OUTCOMES, and FOURIER-OLE trials suggest that achieving extremely low LDL-C levels may further reduce the risk of cardiovascular events in ASCVD patients without substantially increasing clinically relevant adverse events; however, randomized data was still scarce in supporting this notion.
Against these backgrounds, we have designed this trial to investigate whether targeting LDL-C levels <0.8 mmol/L in high-risk ASCVD patients results in a significant reduction in adverse events compared to targeting LDL-C levels of 0.8-1.4 mmol/L.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDL-C target < 0.8 mmol/L | Experimental | Other: Intensive LDL-C controlAfter randomization, investigators will optimize the intensive lipid-lowering regimen based on the patient's prior medication history, baseline LDL-C level, and target LDL-C level, adjusting and titrating LDL-C levels to achieve the target range. |
| LDL-C target of 0.8 to 1.4 mmol/L | Active comparator | Other: Conventional LDL-C controlAfter randomization, investigators will optimize the intensive lipid-lowering regimen based on the patient's prior medication history, baseline LDL-C level, and target LDL-C level, adjusting and titrating LDL-C levels to achieve the target range. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients underwent percutaneous coronary intervention due to acute or chronic coronary syndrome
- Patients with ASCVD at extremely high risk
- Patients who are able to complete the follow-up and compliant with the allocated treatment
Key exclusion criteria (9 listed)
- Age less than 18 years;
- Unable to give informed consent or currently participating in other trials;
- Patient who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to randomization in women of child-bearing potential according to local practice), or plans to become pregnant during treatment;
- Concurrent medical condition with a life expectancy of less than 3 years;
- Hemodynamic unstable;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive LDL-C controlBy Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up; For patients with baseline LDL-C level < 3.0 mmol/L, it is recommended to start lipid control by statin + PCSK9i; for LDL-C level ≥ 3.0 mmol/L, statin + ezetimibe + PCSK9i | Other | LDL-C target < 0.8 mmol/L |
| Conventional LDL-C controlBy Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up; For patients with baseline LDL-C level < 3.0 mmol/L, it is recommended to start lipid control by statin alone or statin + ezetimibe; for LDL-C level ≥ 3.0 mmol/L, statin + PCSK9i | Other | LDL-C target of 0.8 to 1.4 mmol/L |
Primary outcome
Major Adverse Cardiovascular and Cerebrovascular Events
Time frame: 24 months
MACCE, a composite of cardiovascular death, stroke, myocardial infarction, and any revascularization.
13 secondary outcomes
Patient-oriented composite endpoint
Time frame: 24 months
Device-oriented Composite Endpoint
Time frame: 24 months
Composite of all-cause death, stroke, and myocardial infarction
Time frame: 24 months
All-cause death
Time frame: 24 months
Cardiovascular death
Time frame: 24 months
Myocardial infarction
Time frame: 24 months
Stroke
Time frame: 24 months
Ischemic stroke
Time frame: 24 months
Hemorrhagic stroke
Time frame: 24 months
Revascularization
Time frame: 24 months
Target lesion revascularization
Time frame: 24 months
Clinically and physiologically-indicated target lesion revascularization
Time frame: 24 months
Cardiovascular hospitalization
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ling Tao, Ph.D., M.D. study chair
Department of Cardiology, Xijing Hospital
Chao Gao, Ph.D., M.D. study chair
Department of Cardiology, Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Coronary Syndrome and Acute Coronary Syndromes, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Gao, M.D., Ph.D. (86 18629551066, woshigaochao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular and Cerebrovascular Events (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.