Inclisiran Effectiveness in China: a Pragmatic Randomized Trial (V-INVINCIBLE)

Novartis

Status and phase: Not yet enrolling; Phase 4

Conditions: Coronary Heart Disease

Treatments: Combination Product: Standard of Care; Drug: inclisiran sodium injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06941792

CKJX839A1CN06

Details and patient eligibility

About

The current study will be conducted to evaluate the real-world effectiveness of inclisiran relative to standard of care (SoC) in Chinese patients with coronary heart disease (CHD), not only with the low-density lipoprotein cholesterol (LDL-C) change in 1 year, but also the LDL-C Test on Target for 1 year. This study further aims to assess the adherence, treatment patterns and satisfaction, and safety of inclisiran among Chinese patients.

Full description

The study is a multicenter, randomized, parallel, open-label, pragmatic trial, to assess the effectiveness of inclisiran in the real-world compared to SoC, in patients with CHD in China who did not achieve LDL-C goal despite maximally tolerated statin therapy for ≥4weeks stable using. CHD patients include patients with acute coronary syndrome and patients with chronic coronary syndrome.

After granting informed consent, being screened, and confirmed eligible for the study, participants will be randomized to 2 arms (inclisiran or SoC) in a 1:1 ratio.

Following the randomization, participants start inclisiran or SoC adaptation (which means switching to or adding on another/other lipid-lowering therapies (LLT[s]). This start date is defined as Day 0.

During follow-up, each participant will follow routine care, and the results of LDL-C tests will be collected for each Visit (every 3 months), with an allowable window of ±1.5 months. Each patient will be followed up until his/her end of study (EOS), which is the earliest of the end of follow-up period (Visit 4: approximately 12 months following Day 0), lost to follow-up, consent withdrawal, death, and participating in another interventional trial.

Enrollment: 1,590 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent must be obtained prior to participation in the study
2. Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS)
3. Aged ≥18 years at randomization
4. Despite maximally tolerated statin therapy for ≥4weeks stable using prior to screening, LDL-C result at screening not at goal (≥1.8 mmol/L).

The maximum tolerated dose of statins also includes patients with statin intolerance or contraindication.

Exclusion criteria

1. Received inclisiran during the 2 years prior to the screening.
2. Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening.
3. Participating in an interventional trial at enrollment
4. Having severe liver disorder (Child-Pugh class C)
5. Any other condition that may put the participant at significant risk if the participant participate in the current study, according to investigator's (or delegate's) judgment.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,590 participants in 2 patient groups

inclisiran group

Experimental group

Description:

patients in the inclisiran group will receive inclisiran (may or may not plus cholesterol absorption inhibitor at the discretion of the treating physician).

Treatment:

Drug: inclisiran sodium injection

Standard of Care group

Active Comparator group

Description:

Patients in the SoC group will switch to/add on another/other LLT(s) at the discretion of the treating physician, as long as it is not inclisiran or an investigational drug.

Treatment:

Combination Product: Standard of Care