Atherosclerotic Cardiovascular Disease (ASCVD)TARGET-EXTREMENCT07615296
Target-Oriented Strategy of Ultra-Low LDL-C (<1.0 vs. 1.0-1.39 mmol/L) in Extreme-High-Risk ASCVD Patients: Clinical Benefit, Safety and Cost-Effectiveness Assessment
A study testing Lipid-lowering therapy targeting LDL-C <1.0 mmol/L and Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/L in people with Atherosclerotic Cardiovascular Disease (ASCVD), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether an ultra-low LDL-C target (<1.0 mmol/L) can improve clinical outcomes compared with a moderately low LDL-C target (1.0-1.39 mmol/L) in Chinese patients with extreme-high-risk atherosclerotic cardiovascular disease (ASCVD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease (ASCVD)
- What is being tested?
- Lipid-lowering therapy targeting LDL-C <1.0 mmol/L and Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Dec 2031
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years, any sex.
- Diagnosed with ultra-high-risk ASCVD per 2023 Chinese Lipid Guidelines: either ≥2 major ASCVD events within 24 months, or 1 major ASCVD event plus ≥2 high-risk factors (diabetes, multi-vessel disease, premature CHD family history, elevated Lp(a), hypertension).
- LDL-C ≥1.0 mmol/L after ≥4-week maximum-tolerated statin plus ezetimibe therapy, confirmed by central laboratory.
- Able to complete follow-up and examinations; no severe hepatic/renal dysfunction.
- Voluntary participation with written informed consent.
Who cannot join
- Hypersensitivity or intolerance to statins, ezetimibe, or PCSK9 inhibitors.
- Hemorrhagic stroke, active bleeding, severe trauma or major surgery within 6 months before enrollment.
- Malignancy (expected survival <3 years), severe liver/kidney disease, or autoimmune disease.
- Cognitive impairment (MoCA <20) or psychiatric disorders precluding assessment cooperation.
- Pregnant, breastfeeding, or planning pregnancy during the trial.
- Participation in other clinical trials or use of other lipid-lowering drugs within 3 months.
- Poor compliance or other conditions judged by investigators to interfere with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Hai Gao, MD, +86 13901015971, gaohai1221@mail.ccmu.edu.cn
About this study
Official title: Target-Oriented Strategy of Ultra-Low LDL-C Goal in Extreme-High-Risk ASCVD Patients (<1.0 vs. 1.0-1.39 mmol/L): Clinical Benefit, Safety and Cost-Effectiveness Assessment- A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint Adaptive Trial
The goal of this clinical trial is to learn whether an ultra-low LDL-C target (<1.0 mmol/L) can improve clinical outcomes compared with a moderately low LDL-C target (1.0-1.39 mmol/L) in Chinese patients with extreme-high-risk atherosclerotic cardiovascular disease (ASCVD). It also aims to evaluate long-term safety and cost-effectiveness, and explore potential benefit subgroups and underlying mechanisms. The main questions it aims to answer are:
Does an LDL-C target <1.0 mmol/L reduce major adverse cardiovascular events (MACE-4: cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, urgent coronary revascularization) compared with a target of 1.0-1.39 mmol/L?What are the long-term safety risks including cognitive decline, hemorrhagic stroke, new-onset diabetes, new malignancies and severe adverse drug reactions under different LDL-C targets?Researchers will compare participants receiving an LDL-C target <1.0 mmol/L with those receiving a target of 1.0-1.39 mmol/L to see if the ultra-low LDL-C strategy provides better clinical benefit with acceptable safety and economic value.
Read more
Participants will:
Receive lipid-lowering therapy following a mandatory titration-maintenance-off-target correction algorithm according to their assigned LDL-C target Undergo routine follow-up every 3 months, cognitive assessment every 6 months, and comprehensive annual re-examinations for a median of 2 years and up to 5 years Have centralized blinded lipid testing and endpoint adjudication by an independent Clinical Event Committee
- Being tested
- Lipid-lowering therapy targeting LDL-C <1.0 mmol/L, Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/L
- Keywords
- Extreme-high-risk ASCVD, LDL-C target, Ultra-low LDL-C, Lipid-lowering therapy
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid-lowering therapy targeting LDL-C <1.0 mmol/LDrug
Statin-ezetimibe-based lipid-lowering therapy with mandatory titration-maintenance-off-target correction algorithm. PCSK9 inhibitor is sequentially added and dose-adjusted based on centralized blinded lipid test results to achieve LDL-C level <1.0 mmol/L.
Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/LDrug
Standard statin-ezetimibe lipid-lowering therapy. Mandatory dose reduction (discontinue ezetimibe → halve statin → discontinue statin) will be performed if LDL-C drops below 1.0 mmol/L, to maintain LDL-C within 1.0-1.39 mmol/L.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-low LDL-C target group | Experimental | Participants receive statin-ezetimibe-based lipid-lowering therapy with mandatory titration algorithm, adding PCSK9 inhibitor sequentially to achieve LDL-C <1.0 mmol/L. Receives: Drug: Lipid-lowering therapy targeting LDL-C <1.0 mmol/L |
| Moderate-low LDL-C target group | Active comparator | Participants maintain statin-ezetimibe therapy; dose reduction is enforced if LDL-C <1.0 mmol/L to keep level within 1.0-1.39 mmol/L. Receives: Drug: Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events-4 (MACE-4)
Composite endpoint including cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization.
Measured: Median 2 years, up to 5 years from randomization
Secondary outcomes (4)
All-cause mortality
Measured: Median 2 years, up to 5 years post-randomization
Major Adverse Cardiovascular Events-3 (MACE-3)
Measured: Median 2 years, up to 5 years post-randomization
individual components of MACE-4
Measured: Median 2 years, up to 5 years post-randomization
LDL-C target achievement rate
Measured: Median 2 years, up to 5 years post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease (ASCVD)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai Gao, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615296
- Sponsor's protocol ID
- LIPID-2026-001
- Acronym
- TARGET-EXTREME
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target-Oriented Strategy of Ultra-Low LDL-C Goal in Extreme-High-Risk ASCVD Patients (<1.0 vs. 1.0-1.39 mmol/L): Clinical Benefit, Safety and Cost-Effectiveness Assessment- A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint Adaptive Trial
- ClinicalTrials.gov ID
- NCT07615296
- Acronym / sponsor ID
- TARGET-EXTREME / LIPID-2026-001
- Keywords
- Extreme-high-risk ASCVD, LDL-C target, Ultra-low LDL-C, Lipid-lowering therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 29 May 2026 (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.
The goal of this clinical trial is to learn whether an ultra-low LDL-C target (<1.0 mmol/L) can improve clinical outcomes compared with a moderately low LDL-C target (1.0-1.39 mmol/L) in Chinese patients with extreme-high-risk atherosclerotic cardiovascular disease (ASCVD). It also aims to evaluate long-term safety and cost-effectiveness, and explore potential benefit subgroups and underlying mechanisms. The main questions it aims to answer are:
Does an LDL-C target <1.0 mmol/L reduce major adverse cardiovascular events (MACE-4: cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, urgent coronary revascularization) compared with a target of 1.0-1.39 mmol/L?What are the long-term safety risks including cognitive decline, hemorrhagic stroke, new-onset diabetes, new malignancies and severe adverse drug reactions under different LDL-C targets?Researchers will compare participants receiving an LDL-C target <1.0 mmol/L with those receiving a target of 1.0-1.39 mmol/L to see if the ultra-low LDL-C strategy provides better clinical benefit with acceptable safety and economic value.
Participants will:
Receive lipid-lowering therapy following a mandatory titration-maintenance-off-target correction algorithm according to their assigned LDL-C target Undergo routine follow-up every 3 months, cognitive assessment every 6 months, and comprehensive annual re-examinations for a median of 2 years and up to 5 years Have centralized blinded lipid testing and endpoint adjudication by an independent Clinical Event Committee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-low LDL-C target group | Experimental | Drug: Lipid-lowering therapy targeting LDL-C <1.0 mmol/LParticipants receive statin-ezetimibe-based lipid-lowering therapy with mandatory titration algorithm, adding PCSK9 inhibitor sequentially to achieve LDL-C <1.0 mmol/L. |
| Moderate-low LDL-C target group | Active comparator | Drug: Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/LParticipants maintain statin-ezetimibe therapy; dose reduction is enforced if LDL-C <1.0 mmol/L to keep level within 1.0-1.39 mmol/L. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-80 years, any sex.
- Diagnosed with ultra-high-risk ASCVD per 2023 Chinese Lipid Guidelines: either ≥2 major ASCVD events within 24 months, or 1 major ASCVD event plus ≥2 high-risk factors (diabetes, multi-vessel disease, premature CHD family history, elevated Lp(a), hypertension).
- LDL-C ≥1.0 mmol/L after ≥4-week maximum-tolerated statin plus ezetimibe therapy, confirmed by central laboratory.
- Able to complete follow-up and examinations; no severe hepatic/renal dysfunction.
- Voluntary participation with written informed consent.
Key exclusion criteria (7 listed)
- Hypersensitivity or intolerance to statins, ezetimibe, or PCSK9 inhibitors.
- Hemorrhagic stroke, active bleeding, severe trauma or major surgery within 6 months before enrollment.
- Malignancy (expected survival <3 years), severe liver/kidney disease, or autoimmune disease.
- Cognitive impairment (MoCA <20) or psychiatric disorders precluding assessment cooperation.
- Pregnant, breastfeeding, or planning pregnancy during the trial.
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 |
|---|---|---|
| Lipid-lowering therapy targeting LDL-C <1.0 mmol/LStatin-ezetimibe-based lipid-lowering therapy with mandatory titration-maintenance-off-target correction algorithm. PCSK9 inhibitor is sequentially added and dose-adjusted based on centralized blinded lipid test results to achieve LDL-C level <1.0 mmol/L. | Drug | Ultra-low LDL-C target group |
| Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/LStandard statin-ezetimibe lipid-lowering therapy. Mandatory dose reduction (discontinue ezetimibe → halve statin → discontinue statin) will be performed if LDL-C drops below 1.0 mmol/L, to maintain LDL-C within 1.0-1.39 mmol/L. | Drug | Moderate-low LDL-C target group |
Primary outcome
Major Adverse Cardiovascular Events-4 (MACE-4)
Time frame: Median 2 years, up to 5 years from randomization
Composite endpoint including cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization.
4 secondary outcomes
All-cause mortality
Time frame: Median 2 years, up to 5 years post-randomization
Major Adverse Cardiovascular Events-3 (MACE-3)
Time frame: Median 2 years, up to 5 years post-randomization
individual components of MACE-4
Time frame: Median 2 years, up to 5 years post-randomization
LDL-C target achievement rate
Time frame: Median 2 years, up to 5 years post-randomization
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 29 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid-lowering therapy targeting LDL-C <1.0 mmol/L and Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/L in people with Atherosclerotic Cardiovascular Disease (ASCVD), run by Beijing Anzhen 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 5 inclusion and 7 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 29 May 2026. 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 Hai Gao, MD (+86 13901015971, gaohai1221@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events-4 (MACE-4) (time frame: Median 2 years, up to 5 years from randomization). 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 29 May 2026.