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Heart attack prevention shot tested in 16,000 patients

NCT ID NCT03705234

Disease control Sponsor: University of Oxford Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large phase 3 study tests a new cholesterol-lowering injection called inclisiran in over 16,000 people who have already had a heart attack, stroke, or artery surgery. The goal is to see if it safely reduces the risk of future heart attacks, strokes, or the need for emergency procedures. Participants receive either the injection or a placebo, and researchers track major heart events over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

16,124 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Dec 2049

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria History or evidence of at least one of the following: * Prior MI; or * Prior ischemic stroke; or * Peripheral artery disease as evident by prior lower extremity artery revascularization or aortic aneurysm repair. Minimum age is 40 years for men and 55 years for women Exclusion Criteria None of the following must be satisfied (based on self-reported medical history): * Acute coronary syndrome or stroke less than 4 weeks before the Screening visit or during the Run-in period; * Coronary revascularization procedure planned within the next 6 months; * Known chronic liver disease; * Current or planned renal dialysis or transplantation; * Previous exposure to inclisiran or participation in a randomized trial of inclisiran; * Previous (within about 3 months), current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran (none currently known); * Known to be poorly compliant with clinic visits or prescribed medication; * Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; cancer or evidence of spread within approximately the last 5 years, other than non-melanoma skin cancer; or history of alcohol or substance misuse) or may put the individual at significant risk in the opinion of the investigator (or their authorised deputy) if he/she were to participate in the trial; * Women of child-bearing potential, current pregnancy, or lactation; * Current participation in a clinical trial with an unlicensed drug or device; or * Staff personnel directly involved with the study and any family member of the investigational study staff.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerotic cardiovascular disease

Contacts and locations

Locations

  • CTSU, University of Oxford

    Oxford, Oxfordshire, OX3 7LF, United Kingdom

  • TIMI Study Group

    Boston, Massachusetts, 02115, United States

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