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Effect van Colchicine op de Progressie van Coronaire Atherosclerose bij Patiënten met een TET2-CHIP Variant

30 september 2026 bijgewerkt door: Han Yaling, Shenyang Northern Hospital

Effect van Colchicine op de Progressie van Coronaire Atherosclerose bij Patiënten met TET2-CHIP Variant: een Pilot Klinische Studie (COLCHIP-Pilot)

This study aims to investigate whether TET2-associated clonal hematopoiesis of indeterminate potential (TET2-CHIP) can serve as a biomarker to guide precision use of colchicine in a population of clinically stable post-ACS patients receiving standard of care (SoC) therapy. Specifically, we will evaluate whether TET2-CHIP status predicts a differential response to colchicine. As a pilot study, it also aims to provide detailed data supporting design of further trial, such as sample size calculating, endpoint optimizing, etc.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a single-center, prospective, randomized, open-label, assessor-blinded pilot trial. A total of 120 patients will be enrolled and stratified by CHIP variant status into a TET2-CHIP group or a non-CHIP group. TET2-CHIP group (N = 60): Participants will be randomized (1:1) to colchicine 0.5 mg once daily plus SoC therapy (n = 30) or SoC therapy alone (control; n = 30). Non-CHIP group (N = 60): Participants will be randomized (1:1) to colchicine 0.5 mg once daily plus SoC therapy (n = 30) or SoC therapy alone (control; n = 30). SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines. Patients should also be instructed to follow heart healthy (low fat) diet and regular exercise program. The index qualifying ACS must have occurred at least 30 days and no more than 90 days prior to randomization.

Baseline assessment for all participants will include coronary CT angiography (CCTA) using photon-counting detector CT (PCD-CT), inflammatory biomarkers testing and CHIP variant sequencing. After randomization, participants will have visits at Month 0, 1, 3, 6, 9, and 12. Repeat CCTA for the assessment of coronary plaque will occur during the Month 12 visit. The primary endpoint is the percent change in total plaque volume in non-culprit coronary lesion from baseline to Month 12, measured by CCTA. Secondary endpoints include the percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque from baseline to Month 12; change in levels of inflammatory biomarkers (IL-6, IL-1β, IL-18, hs-CRP, and S100A12); change in the TET2-CHIP variant allele fraction; and major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization. Participants will be followed for 12 months.

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Zaixin Jiang, MD, PhD
  • Telefoonnummer: +8618646330195
  • E-mail: jzxdr2013@163.com

Studie Locaties

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • Werving
        • General Hospital of Northern Theater Command
        • Hoofdonderzoeker:
          • Yaling Han, MD, PhD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Age 40-85 years;

  2. Patients with recent hospitalization for documented ACS (the index event occurring 30-90 days before randomization) and meeting all of the following:

    1. During the index hospitalization, patients underwent either PCI or diagnostic coronary angiography alone,
    2. At least one non-culprit coronary lesion with 30%-70% diameter stenosis by visual estimation on coronary angiography,
    3. Clinically stable throughout the screening period,
    4. Receiving standard of care therapy for ACS in accordance with national guidelines,
    5. Peripheral blood DNA available for targeted sequencing, with results demonstrating either TET2-CHIP or no CHIP-associated variants;

  3. Written informed consent.

Exclusion Criteria:

  1. Prior coronary artery bypass grafting (CABG) before documented ACS;
  2. Other clinically significant cardiovascular diseases, including moderate-to-severe valvular heart disease (moderate or severe), heart failure (NYHA class III-IV), or atrial fibrillation;
  3. Non-culprit coronary anatomy (e.g., marked tortuosity, bifurcation lesions, or small vessels <1.5 mm in diameter) deemed to preclude plaque assessment by CCTA;
  4. Planned PCI or CABG;
  5. Abnormal liver function (ALT >3 times the upper limit of normal range) at randomization;
  6. Abnormal renal function (serum creatinine >1.5 times the upper limit of normal range or estimated eGFR <45 mL/min/1.73 m²) at randomization;
  7. Hematologic abnormalities: anemia (hemoglobin <100g/L), thrombocytopenia (platelet count <100×109/L) or leukopenia (white blood cell <3×109/L) at randomization;
  8. Inflammatory bowel disease (Crohn's or ulcerative colitis) or active diarrhea;
  9. Symptomatic peripheral neuropathy, pre-existing progressive neuromuscular disease or creatine kinase (CK) level > 3 times the upper limit of normal range as measured within the past 30 days and determined to be non-transient through repeat testing;
  10. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception;
  11. Any contraindication, known allergy or intolerance to colchicine;
  12. Colchicine use within 30 days prior to randomization, or planned colchicine therapy for other indications;
  13. Current or planned use of any of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics;
  14. Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs;
  15. History of malignancy (hematologic or solid-tumor);
  16. History of transplantation (hematopoietic stem cell or solid-organ);
  17. Significant radiation exposure (≥40 mSv) within the past 12 months;
  18. Known hypersensitivity to iodinated contrast media or uncontrolled active hyperthyroidism;
  19. Current enrollment in another clinical trial;
  20. A predicted life expectancy < 1 year;
  21. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Colchicine with SoC therapy (TET2-CHIP group)

Participants with TET2-CHIP will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months.
Geneesmiddel: Colchicine 0.5 mg orally once daily for 12 months.

SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines.

Ander: SoC therapy

SoC therapy
Geen tussenkomst: SoC therapy alone (TET2-CHIP group)

Participants with TET2-CHIP will receive SoC therapy alone (no colchicine) for 12 months.
Experimenteel: Colchicine with SoC therapy (non-CHIP group)

Participants without CHIP-associated variants will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months.
Geneesmiddel: Colchicine 0.5 mg orally once daily for 12 months.

SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines.

Ander: SoC therapy

SoC therapy
Geen tussenkomst: SoC therapy alone (non-CHIP group)

Participants without CHIP-associated variants will receive SoC therapy alone (no colchicine) for 12 months.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent change in total plaque volume of coronary artery plaque
Tijdsspanne: Up to 12 months

Percent change in total plaque volume of coronary artery plaque measured by CCTA
Up to 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque
Tijdsspanne: Up to 12 months

Percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque measured by CCTA.
Up to 12 months
Change in levels of inflammatory biomarkers
Tijdsspanne: Up to 12 months

Change in levels of circulating IL-6, IL-1β, IL-18, hs-CRP, and S100A12.
Up to 12 months
Change in TET2-CHIP variant allele fraction at 6 months
Tijdsspanne: Up to 6 months

Change in TET2-CHIP variant allele fraction measured by next generation sequencing.
Up to 6 months
Change in TET2-CHIP variant allele fraction at 12 months
Tijdsspanne: Up to 12months

Change in TET2-CHIP variant allele fraction measured by next generation sequencing.
Up to 12months
Major adverse cardiovascular events (MACE)
Tijdsspanne: Up to 12 months

A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization.
Up to 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shenyang Northern Hospital

Onderzoekers

  • Studie stoel: Yaling Han, MD, PhD, The General Hospital of Northern Theater Command

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 juni 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

15 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 januari 2026

Eerst geplaatst (Werkelijk)

23 januari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

30 september 2026

Laatst geverifieerd

1 januari 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PRECISE

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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