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New shot before angioplasty may shield heart attack patients

NCT ID NCT06683131

Disease control Sponsor: The Affiliated Hospital of Xuzhou Medical University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether starting the drug tafolecimab (a PCSK9 inhibitor) just before emergency angioplasty can lower the chance of major heart problems over the next year in people having a heart attack. About 1,160 adults will either get the drug plus standard care or standard care alone. The drug is given as a shot before the procedure and then every two weeks for a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tafolecimab (a PCSK9 inhibitor drug given by injection)
What this could lead to
If it works, this could provide a new treatment option to reduce the risk of future heart problems after a heart attack.
What could go wrong
This is a Phase 4 trial, so the drug is already approved for other uses, but its benefit in this specific setting is unproven. Side effects from injections or the drug itself are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 2027

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

18 to 75 years

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: * Adults 18-75 years old * AMI diagnosed according to the latest guidelines, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) * The requirement for STEMI was that primary PCI was scheduled within 12 hours of onset. * The requirement for NSTEMI was that coronary angiography was scheduled within 2 hours for very high-risk participants and within 24 hours for high-risk participants . * Regardless of baseline LDL-C levels * Participants voluntarily took part in this study and signed informed consent Exclusion Criteria: * Previous or ongoing treatment for any PCSK9i * Allergy to PCSK9i, statins, or any of the drug ingredients used during the trial * History of hemorrhagic cerebrovascular disease * History of old myocardial infarction/chronic heart failure * History of PCI or coronary artery bypass grafting (CABG) or preparation for CABG * Above Killip level II * Prolonged cardiopulmonary resuscitation (\>20min) * Definite mechanical complications (including perforation of the interventricular septum, or rupture of the papillary tendon bundle or the left ventricular free wall) * malignant arrhythmia * Severe uncontrolled infection, bleeding disorder, end-stage renal disease, severe liver disease, endocrine dysfunction, or the expected less than 1 year survival of malignant tumors * Pregnant or lactating women * Participate in other clinical trials

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction

As listed by the trial registrant

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

Acute myocardial infarction (AMI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu, China

  • Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University)

    Nanjing, Jiangsu, China

  • Lianyungang Municipal Dongfang Hospital

    Lianyungang, Jiangsu, China

  • Peking University First Hospital

    Beijing, 100000, China

  • Shanghai Tenth People's Hospital

    Shanghai, China

  • Suining County People's Hospital

    Xuzhou, Jiangsu, China

  • Suqian Hospital of Jiangsu Provincial People's Hospital

    Suqian, Jiangsu, China

  • Taihe County People's Hospital

    Fuyang, Anhui, China

  • The Fifth People's Hospital of Huai'an City

    Huai'an, Jiangsu, China

  • The Fourth Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, China

  • The affiliated hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006, China

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, China

  • Xuzhou Mining Group General Hospital

    Xuzhou, Jiangsu, China

More trials for these conditions

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