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
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.
- 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