NCT07276282Toboroz3. fázis
Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction
Effects of Ziltivekimab Versus Placebo on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction. A Serial, Multivessel, Intravascular Ultrasound, Near-infrared Spectroscopy and Optical Coherence Tomography Imaging Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 23.
Rövid összefoglaló (regiszter, angolul)
Despite improvements in the treatment, coronary artery disease (CAD) remains one of the leading causes of death worldwide. Around 20% of people who have suffered a heart attack (myocardial infarction) need to be hospitalized again within a year, and 10% experience another heart attack. Despite currently available medication, patients remain at risk of further episodes after a heart attack. Scientists have discovered that inflammation in the body plays a decisive role in the development and narrowing of arterial blockages (atherosclerosis). This study aims to investigate whether a new treatment that reduces inflammation can help improve the arteries of patients with CAD. This study will examine whether blocking certain inflammation-related substances with a new medicinal product called ziltivekimab affects the buildup and composition of plaques (fatty deposits) in the coronary arteries. Special imaging diagnostic techniques will be used to look inside the arteries and check whether the treatment helps reduce the narrowing caused by dangerous plaques, which can lead to future heart attacks. This is a clinical study in which participants are randomly divided into two groups (randomization): one group will receive the new treatment ziltivekimab and other group will receive a placebo (a harmless substance with no active ingredients). Both groups will continue to receive standard treatment for heart attacks. The study lasts approximately 15 months per participant. The full scientific title of the trial is: Effects of ziltivekimab versus placebo on coronary atherosclerosis in patients with acute myocardial infarction. A study with serial multi-vessel imaging obtained using intravascular ultrasound, near-infrared spectroscopy, and optical coherence tomography techniques.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 332 (tervezett)
- Első benyújtás
- 2025. nov. 28.
- Kezdés
- 2025. dec. 19.
- Elsődleges befejezés
- 2028. szept. 1.
- Fő szponzor
- ECRI bv
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT07276282
- EU CT-szám
- 2024-520364-34-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 332
- 2025. dec. 19. és az elsődleges befejezés (2028. szept. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Current use of anti-IL-6 products or anticipated use of such drugs any time during the study.
- Planned surgery within 12 months from the time of screening.
- Received a live or attenuated-live vaccine product within 4 weeks of study intervention administration or expected to receive a live or attenuated-live vaccine product during the treatment period.
Más betegség
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel.
- Left-main disease.
- Three-vessel disease.
- History of coronary artery bypass surgery.
- Uncontrolled cardiac arrhythmia.
- Severe kidney impairment.
- Active liver disease or hepatic dysfunction.
- Use of systemic immunosuppressive drugs or disease modifying anti-rheumatic drugs or anticipated chronic use of such drugs any time during the study.
- Known, or suspicion of, active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator
- History of recurrent serious infections.
- Known (acute or chronic) hepatitis B or hepatitis C
- History of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, low risk prostate cancer, or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN) at the discretion of the investigator.
- Major cardiac surgical within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG).
Egyéb
- Female of childbearing potential.
- TIMI flow \<2 of the infarct-related artery after PCI.
- Unstable clinical status (hemodynamic or electrical instability.
- Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation.
- Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals.
- Estimated life expectancy less than 2 years
Kiket keres a vizsgálat
- Informed consent obtained before any study-related activities.
- Age 18 years or above at the time of providing informed consent.
- Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with PCI.
- At least two major native coronary arteries each meeting angiographic criteria for intracoronary imaging immediately following the qualifying PCI procedure.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Bern University Hospital, Inselspital Bern Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Bern | Svájc | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.