NCT06683131 (IMPROVE-AMI) is a Phase 4 clinical trial of Tafolecimab in Acute Myocardial Infarction (AMI), sponsored by The Affiliated Hospital of Xuzhou Medical University.

Who is sponsoring NCT06683131?

NCT06683131 is sponsored by The Affiliated Hospital of Xuzhou Medical University.

What drugs are being tested in NCT06683131?

Interventions in NCT06683131: Tafolecimab.

What condition does NCT06683131 study?

NCT06683131 studies Acute Myocardial Infarction (AMI).

Is NCT06683131 still recruiting?

NCT06683131 is currently not yet recruiting. Last updated 21 November 2025.

Last reviewed 2025-11-21 · How we verify

NCT06683131: IMPROVE-AMI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients

Not yet recruiting Phase 4 Last updated 21 November 2025

What this trial tests

Phase 4 trial testing Tafolecimab in Acute Myocardial Infarction (AMI) in 1,160 participants. Not yet recruiting.

Timeline

20 November 2025

Primary endpoint
30 November 2027

30 November 2027

Quick facts

Lead sponsor	The Affiliated Hospital of Xuzhou Medical University
Phase	Phase 4
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,160
Start date	20 November 2025
Primary completion	30 November 2027
Estimated completion	30 November 2027
Sites	13 locations across China

Drugs / interventions tested

Tafolecimab — full drug profile →

Conditions studied

Acute Myocardial Infarction (AMI) — all drugs for Acute Myocardial Infarction (AMI) →

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Who can join

Adults 18 to 75, any sex, with Acute Myocardial Infarction (AMI). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are: * Does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events? * Does drug tafolecimab improve the coronary microvascular dysfunction? * What medical problems do participants have when administering drug tafolecimab by injection? Researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat AMI. Participants will: * Administer drug tafolecimab by injection or not every month for 12 months * Receive the standard of care of AMI * Complete the measurement of coronary angiography-derived microcirculation resistance index after PCI * Complete cardiac magnetic resonance after PCI if available * Visit the clinic at 1,6,12 months after the first administration for checkups and tests * Report any discomfort, event or queries at any time

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2024.
Tamargo J, Agewall S, Ambrosio G, Borghi C, et al · · 2025 · cited 6× · PMID 40058879 · DOI 10.1093/ehjcvp/pvaf012
A predictive nomogram for intramyocardial hemorrhage in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention based on coronary angiography-derived index of microcirculatory resistance.
Wang Y, Lu Y, Yang Y, Han S, et al · · 2025 · PMID 40770686 · DOI 10.1186/s12872-025-05057-0

Verify or expand the search:

Other trials of Tafolecimab

Trials testing the same drug.

NCT07341958 — INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2) · NA · not yet recruiting
NCT07061535 — Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT06421298 — A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Com · Phase 2 · recruiting
NCT06096909 — Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention i · NA · not yet recruiting

Other recruiting trials for Acute Myocardial Infarction (AMI)

Currently open trials in the same condition.

NCT07400601 — A Clinical Cohort Registry Study on Primary PCI for Acute Myocardial Infarction at Zhongshan Hospital · recruiting
NCT07208006 — Very Early PCSK9 Inhibition for Acute Myocardial Infarction · NA · recruiting
NCT07537296 — Coronary and Myocardial Evaluation by Cardiac CT for Acute Myocardial Infarction · recruiting
NCT07276282 — Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction · Phase 3 · recruiting
NCT07293923 — Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock · NA · recruiting

Other The Affiliated Hospital of Xuzhou Medical University trials

Trials by the same sponsor.

NCT07295366 — Early Administration of PCSK9 Inhibitors After Thrombectomy for Atherosclerotic Acute Ischemic Stroke: A Randomized Cont · Phase 4 · recruiting
NCT07285395 — AT1019 Plus SBRT and PD-1 Inhibitor for Advanced Solid Tumors: An IIT Study · Phase 1 · recruiting
NCT07301372 — Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemi · Phase 4 · recruiting
NCT07133776 — Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Di · Phase 1, PHASE2 · not yet recruiting
NCT07133763 — Application of PD-1 Inhibitors, Tenofovir, Chidamide, and Lenalidomide in Relapsed/Refractory EBV-associated Lymphoproli · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06683131 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Affiliated Hospital of Xuzhou Medical University
Last refreshed: 21 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06683131.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing